Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial (OASIS)

• ClinicalTrials.gov Identifier: NCT04809064
• Recruitment Status: Recruiting
• First Posted: March 22, 2021
• Last Update Posted: July 7, 2023
• Sponsor: University of Pittsburgh
• Collaborator: Walter Reed National Military Medical Center
• Information provided by (Responsible Party): Adam Popchak, University of Pittsburgh

Study Description

Brief Summary:

This clinical trial will investigate the effects of three surgical procedures and the associated post-operative rehabilitation to optimize time to return to military duty, work and sports, and patient-reported physical function for military personnel and civilians with traumatic anterior shoulder instability and 10-20% glenoid bone loss.

Condition or disease	Intervention/treatment	Phase
Shoulder Dislocation; Glenohumeral Dislocation; Anterior Shoulder Dislocation	Procedure: Arthroscopic Bankart repair procedure; Procedure: Open Bankart; Procedure: Latarjet; Other: Post-Operative Rehabilitation	Not Applicable

Detailed Description:

The objective of this clinical trial is to determine the optimal surgical procedure and post-operative rehabilitation strategy for treatment of military personnel and civilians with shoulder instability and subcritical bone loss. Investigators will conduct a randomized, controlled trial comparing arthroscropic Bankart with remplissage/rehabilitation versus open Bankart/rehabilitation versus Latarjet/rehabilitation.

Aim 1: The investigators will determine the effects of arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion versus open Bankart versus Latarjet on patient reported outcomes (Western Ontario Shoulder Instability score [WOSI]), time to Return to Duty/Activity (RTD/A) at pre-injury levels, and recurrent instability/re-injury at 6 months, 1 and 2 years.

Aim 2: The investigators will determine if participation in rehabilitation that optimizes range of motion, strength, and functional performance predicts successful RTD/A, WOSI score, and recurrent instability at 6 months, 1, and 2 years.

Subject Population: Male and female military personnel and civilians between the ages of 17 and 50 with a traumatic anterior shoulder dislocation with associated 10-20% glenoid bone loss and plans to return to physically demanding work or sports, without multi-directional instability, concomitant shoulder pathologies (e.g. rotator cuff tears, motor nerve lesion, fractures, osteoarthritis > Samilson Pietro grade 2), neuromuscular conditions including seizures, a history of shoulder surgery related to any intraarticular soft tissue, and vascular injury will be eligible to participate.

Study / Experimental Design: Randomized controlled trial (Aim 1), Prospective cohort (Aim 2).

Methodology: 400 individuals will be randomized to arthroscopic Bankart with remplissage of a Hill-Sachs lesion/rehabilitation vs. open Bankart/rehabilitation vs. open Latarjet/rehabilitation.

To address Aim 1, individuals with traumatic anterior shoulder instability with subcritical bone loss will be randomized to arthroscopic Bankart repair with remplissageof a Hill-Sachs lesion, or open Bankart, or Latarjet. To address Aim 2, all individuals will enter into rehabilitation with specific instructions for the first 12 weeks dependent on the surgical arm to which they are randomized. After week 12, all rehabilitation programs will be similar and progressed based upon the results of interim testing at 3, 4, and 6 months.

Participants will be followed for 24 months, with primary outcomes consisting of patient-reported physical function and time to return to pre-injury military duty, work and sports. Secondary outcomes will include shoulder-specific and generic patient-reported measures of physical function and health related quality of life and recurrent instability.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
• Actual Study Start Date: January 24, 2022
• Estimated Primary Completion Date: September 2024
• Estimated Study Completion Date: September 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arthroscopic Bankart repair with remplissage of Hill-Sachs lesion/rehabilitation; Arthroscopic Bankart repair surgery with remplissage of Hill-Sachs lesion and post-operative rehabilitation.	Procedure: Arthroscopic Bankart repair procedure; Bankart repair with remplissage consists of arthroscopic anterior inferior capsulolabral repair with arthroscopic infraspinatus tenodesis to the posterior humeral head.; Other: Post-Operative Rehabilitation; Post-operative rehabilitation will be conducted following surgical procedure-specific rehabilitation guidelines and will be progressed based on individual needs.
Experimental: Open Bankart/rehabilitation; Open Bankart surgery and post-operative rehabilitation.	Procedure: Open Bankart; Open Bankart repair consists of anterior capsulorrhaphy with labral repair.; Other: Post-Operative Rehabilitation; Post-operative rehabilitation will be conducted following surgical procedure-specific rehabilitation guidelines and will be progressed based on individual needs.
Experimental: Latarjet/rehabilitation; Latarjet surgical procedure and post-operative rehabilitation.	Procedure: Latarjet; Latarjet consists of open transfer of the coracoid to the anterior glenoid bone deficiency.; Other: Post-Operative Rehabilitation; Post-operative rehabilitation will be conducted following surgical procedure-specific rehabilitation guidelines and will be progressed based on individual needs.

Outcome Measures

Primary Outcome Measures :

1. Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 3 months after randomization ]
   The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
2. Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 6 months after randomization ]
   The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
3. Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 12 months after randomization ]
   The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
4. Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 24 months after randomization ]
   The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
5. Time to Return to Pre-Injury Level of Activity [ Time Frame: Monthly starting at 3 months after randomization and continuing to 24 months ]
   Time to return to pre-injury level military duty, work and sports.
6. Recurrent Instability / Re-injury [ Time Frame: 3 months after randomization ]
   Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
7. Recurrent Instability / Re-injury [ Time Frame: 6 months after randomization ]
   Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
8. Recurrent Instability / Re-injury [ Time Frame: 12 months after randomization ]
   Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
9. Recurrent Instability / Re-injury [ Time Frame: 24 months after randomization ]
   Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.

Secondary Outcome Measures :

1. Single Assessment Numerical Evaluation (SANE) [ Time Frame: 3 months after surgery ]
   The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
2. Single Assessment Numerical Evaluation (SANE) [ Time Frame: 6 months after surgery ]
   The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
3. Single Assessment Numerical Evaluation (SANE) [ Time Frame: 12 months after surgery ]
   The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
4. Single Assessment Numerical Evaluation (SANE) [ Time Frame: 24 months after surgery ]
   The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
5. Brophy Shoulder Activity Level [ Time Frame: 3 months after randomization ]
   The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.
6. Brophy Shoulder Activity Level [ Time Frame: 6 months after randomization ]
   The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.
7. Brophy Shoulder Activity Level [ Time Frame: 12 months after randomization ]
   The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.
8. Brophy Shoulder Activity Level [ Time Frame: 24 months after randomization ]
   The Brophy Shoulder Activity Level is a patient-reported measure of participant's level of sports activity. It consists of 5 items that are rated in a 5-point scale (0-4), where higher scores indicate greater activity engagement. Possible scores on the scale range from 0 - 20.
9. Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE) [ Time Frame: 3 months after randomization ]
   The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.
10. Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE) [ Time Frame: 6 months after randomization ]
    The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.
11. Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE) [ Time Frame: 12 months after randomization ]
    The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.
12. Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE) [ Time Frame: 24 months after randomization ]
    The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Scale - Upper Extremity (UE) consists of an item bank of 121 items that assesses physical function regardless of the health condition present that can be administered as a computer adaptive test (CAT) or through the use of short forms. The Physical Function scale scores transformed to a T-score in which a score of 50 represents the US population average with a standard deviation of 10 indicating the population standard deviation.
13. Patient-Reported Outcome Measurement Information System (PROMIS) Global-10 [ Time Frame: 3 months after surgery ]
    The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.
14. Patient-Reported Outcome Measurement Information System (PROMIS) Global-10 [ Time Frame: 6 months after surgery ]
    The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.
15. Patient-Reported Outcome Measurement Information System (PROMIS) Global-10 [ Time Frame: 12 months after surgery ]
    The PROMIS Global-10 is a 10-item patient reported global measure of physical and emotional health. The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.
16. Patient-Reported Outcome Measurement Information System (PROMIS) Global-10 [ Time Frame: 24 months after surgery ]
    The PROMIS Global-10 is a 10-item patient reported global measure of physical and emotional health. The PROMIS-10 Global Health also measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. It includes physical and mental health component scores that can be transformed to t score distributions with a mean of 50 and standard deviation of 10. A higher score indicates better health.
17. Tampa Scale for Kinesiophobia-11 (TSK-11) [ Time Frame: 3 months after surgery ]
    The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.
18. Tampa Scale for Kinesiophobia-11 (TSK-11) [ Time Frame: 6 months after surgery ]
    The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.
19. Tampa Scale for Kinesiophobia-11 (TSK-11) [ Time Frame: 12 months after surgery ]
    The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.
20. Tampa Scale for Kinesiophobia-11 (TSK-11) [ Time Frame: 24 months after surgery ]
    The Tampa Scale for Kinesiophobia-11 quantifies fear of re-injury due to movement and physical activity. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Total TSK-11 scores range from 11 - 44, with higher scores indicating greater fear of pain, movement, and injury.
21. Brief Resilience Scale [ Time Frame: 3 months after randomization ]
    The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.
22. Brief Resilience Scale [ Time Frame: 6 months after randomization ]
    The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.
23. Brief Resilience Scale [ Time Frame: 12 months after randomization ]
    The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.
24. Brief Resilience Scale [ Time Frame: 24 months after randomization ]
    The Brief Resilience Scale is a 6-item questionnaire that measures an individual's ability to recover from an ongoing health related stress. It uses a 5-point Likert scale that ranges from "strongly disagree" to "strongly agree." Totally, the individual responses creates a range of possible scores from 6 - 30. The total score is then divided by the total number of questions answered for the final score. The scores range from 1 to 5, where higher scores indicate positive resilience capabilities.
25. Patient Acceptable Symptom State (PASS) [ Time Frame: 3 months after randomization ]
    The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.
26. Patient Acceptable Symptom State (PASS) [ Time Frame: 6 months after randomization ]
    The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.
27. Patient Acceptable Symptom State (PASS) [ Time Frame: 12 months after randomization ]
    The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.
28. Patient Acceptable Symptom State (PASS) [ Time Frame: 24 months after randomization ]
    The Patient Acceptable Symptom State is assessed by asking the participant the question: Taking into account all the activity you have during your daily life, your level of pain and also activity limitations and participation restrictions, do you consider the current state of your shoulder satisfactory?" The PSS question is answered "Yes" or "No". A response of "Yes" indicates that the individual is satisfied with his/her current symptom state. The PASS question has show to have sufficient rest re-test reliability in patients after orthopaedic surgery, with a reported kappa coefficient of 0.78.
29. Functional Comorbidity Index [ Time Frame: 3 months after surgery ]
    The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.
30. Functional Comorbidity Index [ Time Frame: 6 months after surgery ]
    The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.
31. Functional Comorbidity Index [ Time Frame: 12 months after surgery ]
    The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.
32. Functional Comorbidity Index [ Time Frame: 24 months after surgery ]
    The Functional Comorbidity Index (FCI) is an 18-item measure assessing the presence of medical comorbidities. The FCI is a self-administered report of medical comorbidities associated with physicla function. Using medical comorbidities is an important factor in creating risk adjustment models for orthopaedic trauma. The FCI was found to demonstrate a stronger association with the SF-36 physical function subscale (R2 = 0.29) than the Charleston (R2 = 0.18) and Kaplan-Feinstein (R2 = 0.17) indices. When individuals were classified into high and low function based ont he SF-36, the FCI correctly classified 77% of the cases.
33. Passive Range of Motion of the Shoulder [ Time Frame: 3 months after surgery ]
    The range of passive elevation and external rotation and internal rotation of both shoulders will be measured with a goniometer. Range of motion measurements to the nearest 1 degree will be made with a large clear plastic gonionometer marked in 1 degree increments.
34. Passive Range of Motion of the Shoulder [ Time Frame: 4 months after surgery ]
    The range of passive elevation and external rotation and internal rotation of both shoulders will be measured with a goniometer. Range of motion measurements to the nearest 1 degree will be made with a large clear plastic gonionometer marked in 1 degree increments.
35. Passive Range of Motion of the Shoulder [ Time Frame: 6 months after surgery ]
    The range of passive elevation and external rotation and internal rotation of both shoulders will be measured with a goniometer. Range of motion measurements to the nearest 1 degree will be made with a large clear plastic gonionometer marked in 1 degree increments.
36. Isometric Muscle Strength of the Shoulder [ Time Frame: 3 months after surgery ]
    Isometric muscle strength of shoulder will be assessed in 5 positions (external rotation at 0 degrees, external rotation at 90 degrees, internal rotation at 0 degrees, internal rotation at 90 degrees and scapular plane abduction at 90 degrees) using a hand-held dynamometer.
37. Isometric Muscle Strength of the Shoulder [ Time Frame: 4 months after surgery ]
    Isometric muscle strength of shoulder will be assessed in 5 positions (external rotation at 0 degrees, external rotation at 90 degrees, internal rotation at 0 degrees, internal rotation at 90 degrees and scapular plane abduction at 90 degrees) using a hand-held dynamometer.
38. Isometric Muscle Strength of the Shoulder [ Time Frame: 6 months after surgery ]
    Isometric muscle strength of shoulder will be assessed in 5 positions (external rotation at 0 degrees, external rotation at 90 degrees, internal rotation at 0 degrees, internal rotation at 90 degrees and scapular plane abduction at 90 degrees) using a hand-held dynamometer.
39. Performance on Functional Tests of the Upper Extremity - Closed Kinetic Chain Upper Extremity Stability test [ Time Frame: 4 months after surgery ]
    Closed Kinetic Chain Upper Extremity Stability test: Participants take a full pushup position. They alternatingly touch each hand with the other, as fast as they can, for 15 seconds. Number of touches in 15 seconds.Three trials will be performed and the average value will be calculated.
40. Performance on Functional Tests of the Upper Extremity - Closed Kinetic Chain Upper Extremity Stability test [ Time Frame: 6 months after surgery ]
    Closed Kinetic Chain Upper Extremity Stability test: Participants take a full pushup position. They alternatingly touch each hand with the other, as fast as they can, for 15 seconds. Number of touches in 15 seconds.Three trials will be performed and the average value will be calculated.
41. Performance on Functional Tests of the Upper Extremity - Unilateral Seated Shot-Put test [ Time Frame: 4 months after surgery ]
    Unilateral Seated Shot-Put test: Distance of shot-put recorded in centimeters. The distance a 2.72 kg medicine ball is pushed, from block against participant's back to the site of ball contact on the floor. The participant will complete three trials for each arm, with the average of 3 trials being used for analysis.
42. Performance on Functional Tests of the Upper Extremity - Unilateral Seated Shot-Put test [ Time Frame: 6 months after surgery ]
    Unilateral Seated Shot-Put test: Distance of shot-put recorded in centimeters. The distance a 2.72 kg medicine ball is pushed, from block against participant's back to the site of ball contact on the floor. The participant will complete three trials for each arm, with the average of 3 trials being used for analysis.
43. Performance on Functional Tests of the Upper Extremity - Push-ups [ Time Frame: 4 months after surgery ]
    Push-ups: Number of push-ups that can be completed in 60 seconds is counted. The test is performed twice and the higher number of repetitions achieved is recorded.
44. Performance on Functional Tests of the Upper Extremity - Push-ups [ Time Frame: 6 months after surgery ]
    Push-ups: Number of push-ups that can be completed in 60 seconds is counted. The test is performed twice and the higher number of repetitions achieved is recorded.
45. Performance on Functional Tests of the Upper Extremity - Weighted Overhead Ball Throw [ Time Frame: 4 months after surgery ]
    Weighted Overhead Ball Throw: Participant will throw a 9.07 kg medicine ball overhead, with both hands. Distance of throw recorded in centimeters. Three trials will be performed.
46. Performance on Functional Tests of the Upper Extremity - Weighted Overhead Ball Throw [ Time Frame: 6 months after surgery ]
    Weighted Overhead Ball Throw: Participant will throw a 9.07 kg medicine ball overhead, with both hands. Distance of throw recorded in centimeters. Three trials will be performed.
47. Performance on Functional Tests of the Upper Extremity - Upper Quarter Y-Balance test [ Time Frame: 4 months after surgery ]
    Upper Quarter Y-Balance test: Maximum reach in 3 directions (medial, inferolateral, and superolateral), recorded in centimeters. Subjects stand in a three-point plank position with the tested shoulder perpendicular to the hand and the feet shoulder-width apart. Three test trials will be performed on each side with 30 seconds of rest in between each trial. A normalized composite score is the mean of the average distance in all three reach directions.
48. Performance on Functional Tests of the Upper Extremity - Upper Quarter Y-Balance test [ Time Frame: 6 months after surgery ]
    Upper Quarter Y-Balance test: Maximum reach in 3 directions (medial, inferolateral, and superolateral), recorded in centimeters. Subjects stand in a three-point plank position with the tested shoulder perpendicular to the hand and the feet shoulder-width apart. Three test trials will be performed on each side with 30 seconds of rest in between each trial. A normalized composite score is the mean of the average distance in all three reach directions.
49. Clinical Measures after Surgical Stabilization - Pain [ Time Frame: 2 weeks after surgery ]
    Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
50. Clinical Measures after Surgical Stabilization - Pain [ Time Frame: 6 weeks +/- 2 weeks after surgery ]
    Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
51. Clinical Measures after Surgical Stabilization - Pain [ Time Frame: 3 months after surgery ]
    Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
52. Clinical Measures after Surgical Stabilization - Pain [ Time Frame: 5 months +/- month after surgery ]
    Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
53. Clinical Measures after Surgical Stabilization - Pain [ Time Frame: 12 months after surgery ]
    Pain: Pain intensity will be recorded utilizing an 11-point numeric pain scale (NPRS) that ranges from 0 (no pain) to 10 (worst imaginable pain). Th current, least, and worst pain intensity in the past 24 hours will be recorded and summed to create a pain score that ranges from 0 to 30.
54. Clinical Measures after Surgical Stabilization - Pain Medication Usage [ Time Frame: 2 weeks after surgery ]
    Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
55. Clinical Measures after Surgical Stabilization - Pain Medication Usage [ Time Frame: 6 weeks +/- 2 weeks after surgery ]
    Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
56. Clinical Measures after Surgical Stabilization - Pain Medication Usage [ Time Frame: 3 months after surgery ]
    Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
57. Clinical Measures after Surgical Stabilization - Pain Medication Usage [ Time Frame: 5 months +/- month after surgery ]
    Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
58. Clinical Measures after Surgical Stabilization - Pain Medication Usage [ Time Frame: 12 months after surgery ]
    Pain Medication Usage: At follow-up visit, current narcotic pain medication usage is recorded. Usage (Yes/No): If "Yes," name of medication, dose, frequency of use, and indication is noted.
59. Clinical Measures after Surgical Stabilization - Use of Post-op Brace [ Time Frame: 2 weeks after surgery ]
    Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
60. Clinical Measures after Surgical Stabilization - Use of Post-op Brace [ Time Frame: 6 weeks +/- 2 weeks after surgery ]
    Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
61. Clinical Measures after Surgical Stabilization - Use of Post-op Brace [ Time Frame: 3 months after surgery ]
    Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
62. Clinical Measures after Surgical Stabilization - Use of Post-op Brace [ Time Frame: 5 months +/- month after surgery ]
    Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
63. Clinical Measures after Surgical Stabilization - Use of Post-op Brace [ Time Frame: 12 months after surgery ]
    Use of Post-op Brace: Usage (Yes/No): If "No," date brace was discontinued will be recorded.
64. Clinical Measures after Surgical Stabilization - Wound Status [ Time Frame: 2 weeks after surgery ]
    Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
65. Clinical Measures after Surgical Stabilization - Wound Status [ Time Frame: 6 weeks +/- 2 weeks after surgery ]
    Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
66. Clinical Measures after Surgical Stabilization - Wound Status [ Time Frame: 3 months after surgery ]
    Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
67. Clinical Measures after Surgical Stabilization - Wound Status [ Time Frame: 5 months +/- month after surgery ]
    Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
68. Clinical Measures after Surgical Stabilization - Wound Status [ Time Frame: 12 months after surgery ]
    Wound Status: At follow-up visit, wound status recorded as healed, healing, draining, open, erythema or presence of a superficial wound infection.
69. Clinical Measures after Surgical Stabilization - Neurovascular status [ Time Frame: 2 weeks after surgery ]
    Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
70. Clinical Measures after Surgical Stabilization - Neurovascular status [ Time Frame: 6 weeks +/- 2 weeks after surgery ]
    Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
71. Clinical Measures after Surgical Stabilization - Neurovascular status [ Time Frame: 3 months after surgery ]
    Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
72. Clinical Measures after Surgical Stabilization - Neurovascular status [ Time Frame: 5 months +/- month after surgery ]
    Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
73. Clinical Measures after Surgical Stabilization - Neurovascular status [ Time Frame: 12 months after surgery ]
    Neurovascular status: Assessment of neurovascular status will include assessment of pulses, sensation to pain, and distal motor function. Brachial pulses will be recorded as symmetrical, diminished, or absent. Sensation to pain will be recorded as normal, diminished or absent. Distal motor function of the wrist will be recorded as strong/symmetrical to the contralateral arm, diminished, or absent.
74. Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests [ Time Frame: 2 weeks after surgery ]
    Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded.
75. Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests [ Time Frame: 3 months after surgery ]
    Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded.
76. Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests [ Time Frame: 5 months +/- month after surgery ]
    Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded.
77. Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests [ Time Frame: 12 months after surgery ]
    Additional Diagnostic Tests: At follow-up visit, any additional diagnostic tests will be recorded. (Yes/No): If "Yes," the test, date and indication will be recorded

Eligibility Criteria

• Ages Eligible for Study: 17 Years to 50 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Civilians and military personnel ages 17 to 50
• Traumatic anterior shoulder dislocation
• Associated subcritical bone loss between 10-20% less the glenoid width quantified by standard of care CT scan

Exclusion Criteria:

• Chronic, non-traumatic multi-directional instability based on clinical exam.
• Concurrent shoulder injury (e.g. rotator cuff tears, motor nerve pathologies, osteoarthritis of a Samilson-Prieto grade >2).
• Prior instability or rotator cuff procedure on involved shoulder (including intra-articular soft tissue surgery).
• Humeral sided bone lesion (Hill-Sachs lesion) that is sufficiently large enough to render the lesion "off-track" even after a bony augmentation procedure would be performed.
• Neuromuscular and other movement control pathologies including seizures.
• Vascular injury associated with the shoulder trauma.
• Traumatic brain injury or any condition that would preclude the ability to comply with post-operative guidelines.
• Does not plan to return to pre-injury levels of work, sports or military duty.

Contacts and Locations

Contacts

Contact: Adam Popchak, PhD, PT; (412) 383-6627; ajp64@pitt.edu

Contact: Jonathan Dickens, MD

Locations

United States, California

Naval Medical Center; Not yet recruiting

San Diego, California, United States, 92134

Contact: Lucas McDonald, MD lucas.s.mcdonald@gmail.com

Principal Investigator: Lucas McDonald, MD

United States, Colorado

Evans Army Community Hospital; Not yet recruiting

Fort Carson, Colorado, United States, 80913

Contact: David Tennent, MD davidjtennent@gmail.com

Principal Investigator: David Tennent, MD

Steadman Clinic; Recruiting

Vail, Colorado, United States, 81657

Contact: Matthew Provencher, MD mprovencher@thesteadmanclinic.com

Principal Investigator: Matthew Provencher, MD

United States, Connecticut

University of Connecticut Health Center; Recruiting

Farmington, Connecticut, United States, 06030

Contact: Cory Edgar, MD, PhD

Principal Investigator: Cory Edgar, MD, PhD

United States, Maryland

US Naval Health Clinic (Academy); Not yet recruiting

Annapolis, Maryland, United States, 21402

Contact: Lance LeClere, MD lancend15@gmail.com

Principal Investigator: Lance LeClere, MD

Walter Reed National Military Medical Center; Not yet recruiting

Bethesda, Maryland, United States, 20089

Contact: Kelly Kilcoyne, MD

Principal Investigator: Kelly Kilcoyne, MD

United States, North Carolina

Naval Medical Center Camp Lejeune; Not yet recruiting

Camp Lejeune, North Carolina, United States, 28547

Contact: Kyle Nappo, MD kyle.nappo@gmail.com

Principal Investigator: Kyle Nappo, MD

University of North Carolina at Chapel Hill; Recruiting

Chapel Hill, North Carolina, United States, 27517

Contact: Alex Creighton, MD

Principal Investigator: Alex Creighton, MD

Duke University; Recruiting

Durham, North Carolina, United States, 27705

Contact: Jonathan Dickens, MD jonathan.dickens@duke.edu

Principal Investigator: Jonathan Dickens, MD

Wake Forest University; Recruiting

Winston-Salem, North Carolina, United States, 27157

Contact: Brian Waterman, MD bwaterma@wakehealth.edu

Principal Investigator: Brian Waterman, MD

United States, Pennsylvania

University of Pittsburgh; Recruiting

Pittsburgh, Pennsylvania, United States, 15203

Contact: Albert Lin, MD alin2@upmc.edu

Principal Investigator: Albert Lin, MD

United States, Rhode Island

Rhode Island Hospital- University Orthopedics; Recruiting

Providence, Rhode Island, United States, 02903

Contact: Brett Owens, MD owensbrett@gmail.com

Principal Investigator: Brett Owens, MD

United States, Texas

San Antonio Military Medical Center; Not yet recruiting

Fort Sam Houston, Texas, United States, 78234

Contact: Andrew Sheean, MD ajsheean@gmail.com

Principal Investigator: Andrew Sheean, MD

United States, Virginia

University of Virginia; Not yet recruiting

Charlottesville, Virginia, United States, 22904

Contact: Stephen Brockmeier, MD SFB2E@hscmail.mcc.virginia.edu

Principal Investigator: Stephen Brockmeier, MD

Sponsors and Collaborators

University of Pittsburgh

Walter Reed National Military Medical Center

Investigators

• Principal Investigator: Adam Popchak, PhD, PT; University of Pittsburgh
• Principal Investigator: Jonathan Dickens, MD; Duke University
• Study Chair: James J Irrgang, PhD, PT, ATC; University of Pittsburgh

More Information

• Responsible Party: Adam Popchak, Research Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04809064
• Other Study ID Numbers: PRO20030003; W81XWH-19-PROP-CTA ( Other Grant/Funding Number: Department of Defense )
• First Posted: March 22, 2021
• Last Update Posted: July 7, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: A public-use version of the dataset will be constructed by the Data Coordinating Center (DCC) with contents to be determined jointly by the study PIs and the DCC Director. Copies of the public-use version of the dataset will be housed at the DCC on a secure server along with suitable documentation of this dataset. The public-use version of the dataset will be exported in one or more files in simple, widely-accessible formats, e.g., .xls, .csv, and/or Statistical Analysis Software (SAS) datasets. Documentation will be in .pdf files.
• Supporting Materials: Study Protocol
• Time Frame: The public-use version of the dataset will be made available 2 years after the study's main paper is published.
• Access Criteria: Outside investigators wishing to conduct analyses using the data will submit a request with objectives, methods, and analysis plan to the PI and the Director of the DCC. Once the request is approved, the public-use version of the dataset, with documentation, will be sent by secure email using e-mail, ftp, or other mutually agreeable transmission method.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adam Popchak, University of Pittsburgh:

Anterior Shoulder Instability; Glenoid Bone Loss; Stabilization Surgery; Return to Duty or Sport; Rehabilitation

Additional relevant MeSH terms:

Joint Dislocations; Shoulder Dislocation; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries