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Satisfaction and Recovery After Distal Radius Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05818241
Recruitment Status : Recruiting
First Posted : April 18, 2023
Last Update Posted : April 18, 2023
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Joakim Stromberg, Sahlgrenska University Hospital, Sweden

Study Description
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Brief Summary:
Distal radius fracture is the most common fracture in Sweden, but little is known about the patient's experience of pain and hand function during the first three months after the injury. This observational study will provide detailed information on a daily basis regarding pain, use of analgesic drugs, use of splints and hand function as measured weekly by a condition-specific questionnaire.

Condition or disease Intervention/treatment
Distal Radius Fracture Procedure: Treatment of fracture by forearm cast Procedure: Surgical treatment of fracture

Detailed Description:

Two hundred patients who are treated conservatively in a cast and one hundred patients who have undergone surgery will be asked to complete a questionnaire with the following outcome measures for three months:

  1. Pain (day-by-day registration on a Likert scale, range 0-10)
  2. Analgesic used (day-by-day registration of specific drug, dose and number)
  3. PRWE (Patient Reported Wrist Evaluation form, week-by-week registration)
  4. Use of and evaluation of efficacy of prefabricated wrist splints (week-by-week registration)
  5. Details of sick leave and return to work at completion of the questionnaire at three months.

The study is entirely PROM-based and the patient will not require any additional appointments.

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study on the Immediate Recovery and Satisfaction After Distal Radius Fracture During the First Three Months- a PROM Based Observational Study With Day-to-day Records
Actual Study Start Date : January 12, 2023
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cast
Patients that are conservatively treated (in a cast, either without or with reduction)
 Procedure: Surgical treatment of fracture
Patients that are surgically treated for DRF
Surgery
Patients that undergo surgical treatment (regardless of method)
 Procedure: Treatment of fracture by forearm cast
Patient that are not surgically treated for DRF
Other Name: casting, conservative treatment


Outcome Measures
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Primary Outcome Measures :
  1. Patient-reported hand function [ Time Frame: Every week for three months ]
    Patient Rated Wrist Evaluation (PRWE) questionnaire


Secondary Outcome Measures :
  1. Day-by-day pain record [ Time Frame: Every day for three months ]
    Patient reported pain as measured on a Likert scale 0-10 (0=no pain, 10= maximum pain)

  2. Analgesics [ Time Frame: Every day for three months ]
    Daily record of use of analgesic drugs

  3. Wrist splint usage [ Time Frame: Every week for three months ]
    Patient reported use of splint and evaluation of its efficacy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with a distal radius fracture with the inclusion criteria and without the exclusion criteria at the emergency ward are eligible .
Criteria

Inclusion Criteria:

  • Unilateral distal radius fractures in patients without any other significant injuries regardless of ligament injuries and ulnar fractures.
  • Signed written consent

Exclusion Criteria:

  • Compound injuries
  • Open fractures
  • Patients with post traumatic function deficits at any level in the affected arm prior to the distal radius fracture.
  • Patients with function deficits in the affected arm due to other medical conditions (e.g. Parkinsons disease, Rheumatoid Arthritis)
  • Reduced mental capacity (e.g. dementia, substance abuse)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05818241


Contacts
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Contact: Joakim Stromberg, MD, PhD +46768341327 joakim.stromberg@vgregion.se
Contact: Ingrid Andreasson, PhD +46313421000 ingrid.andreasson@vgregion.se

Locations
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Sweden
Sahlgrenska University Hospital, Department of Hand Therapy Recruiting
Mölndal, Region Västra Götaland, Sweden
Contact: Ingrid Andreasson, PhD    +46313421000    ingrid.andreasson@vgregion.se   
Alingsås Lasarett/ District Hospital Not yet recruiting
Alingsås, Sweden
Contact: Joakim Strömberg       joakim.stromberg@vgregion.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Vastra Gotaland Region
More Information
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Responsible Party: Joakim Stromberg, senior consultant,, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT05818241    
Other Study ID Numbers: DRFx STAR
First Posted: April 18, 2023    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joakim Stromberg, Sahlgrenska University Hospital, Sweden:
wrist function
recovery
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wrist Fractures
Wounds and Injuries
 Forearm Injuries
Arm Injuries
Wrist Injuries