Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology

• ClinicalTrials.gov Identifier: NCT06010979
• Recruitment Status: Recruiting
• First Posted: August 25, 2023
• Last Update Posted: August 25, 2023
• Sponsor: Tian Hua
• Information provided by (Responsible Party): Tian Hua, Peking University Third Hospital

Study Description

Brief Summary:

Through this cohort study, previous clinical data can be systematically reviewed and supplemented through clinical follow-up. Prospective enrollment and follow-up observation of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. The intraoperative, perioperative, clinical follow-up and health economics of surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional TKA were comprehensively and objectively compared, the results and conclusions of the center were summarized and reported, and the effectiveness and safety of digital assistive technology applied to TKA were explored, providing references for clinical diagnosis and follow-up research.

Condition or disease	Intervention/treatment
Knee Osteoarthritis	Procedure: conventional intrumentation assisted knee arthroplasty; Procedure: computer navigation assisted knee arthroplasty; Procedure: robotic system assisted knee arthroplasty; Procedure: patient-spercific assisted knee arthroplasty

Detailed Description:

Through this cohort study, previous clinical data can be systematically reviewed and supplemented by follow-up visits. Prospective enrollment and follow-up of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. The preoperative situation (general statistical information, educational level, preoperative clinical function score, etc.), intraoperative situation (operative time, intraoperative blood loss, intraoperative complications, etc.), perioperative situation (total postoperative blood loss, blood transfusion rate, postoperative complications, etc.) and clinical follow-up situation were comprehensively and objectively compared with surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional TKA We summarized and reported the results and conclusions of the center (postoperative force line, implant location, pain, mobility, clinical function score, patient satisfaction and postoperative complications, etc.) and health economics (average length of stay, hospitalization cost, etc.) to provide reference for clinical diagnosis and follow-up research.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 12000 participants
• Observational Model: Cohort
• Time Perspective: Other
• Target Follow-Up Duration: 3 Years
• Official Title: Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology
• Estimated Study Start Date: January 1, 2024
• Estimated Primary Completion Date: December 31, 2026
• Estimated Study Completion Date: December 31, 2026

Groups and Cohorts

Group/Cohort	Intervention/treatment
conventional group; Conventional instrument-assisted knee arthroplasty	Procedure: conventional intrumentation assisted knee arthroplasty; conventional intrumentation assisted knee arthroplasty
CAS group; computer navigation assisted knee arthroplasty	Procedure: computer navigation assisted knee arthroplasty; computer navigation assisted knee arthroplasty
RAS group; robotic system assisted knee arthroplasty	Procedure: robotic system assisted knee arthroplasty; robotic system assisted knee arthroplasty
PSI group; patient-spercific instrumentation assisted knee arthroplasty	Procedure: patient-spercific assisted knee arthroplasty; patient-spercific assisted knee arthroplasty

Outcome Measures

Primary Outcome Measures :

1. mechanical axis [ Time Frame: Postoperative day 3 ]
   The postoperative HKA Angle was measured, that is, the Angle between the center of the hip joint and the center of the knee joint and the center of the knee joint and the center of the ankle joint on the full-length X-ray film of the lower limb. The target Angle was defined as 0°, the Angle was positive when the knee was varus, the Angle was negative when the knee was varus, and the acceptable range was ±3°, beyond which the line deviation was defined.

Secondary Outcome Measures :

1. operation time [ Time Frame: immediately after the surgery ]
   The surgical time is defined as the time from incision to the completion of the skin suture, accurate to minutes
2. Intraoperative blood loss [ Time Frame: immediately after the surgery ]
   Intraoperative blood loss = total amount of fluid drawn during the operation - intraoperative irrigation volume + intraoperative gauze infiltration blood loss, accurate to ml
3. Intraoperative complications [ Time Frame: immediately after the surgery ]
   Various complications occurred during the operation were recorded
4. Total postoperative blood loss [ Time Frame: Postoperative day 3 ]
   Gross linear equation was used to calculate total blood loss and latent blood loss 3 days after surgery. Total blood loss = preoperative blood volume (PBV) × (preoperative hematocrit - postoperative hematocrit). PBV was calculated using Nadler method: PBV=K1× height (m) 3+K2× weight (kg) +K3, where male K1=0.3669, K2=0.03219, K3=0.6041; Female K1=0.3561, K2=0.03308, K3=0.1833. Postoperative total blood loss = total blood loss - intraoperative blood loss;
5. Blood transfusion rate [ Time Frame: At discharge ]

   The postoperative blood transfusion situation and the amount of blood transfusion were recorded. The blood was transfused mainly with suspended red blood cells, and the amount of a single transfusion was 400ml. The Hb situation was evaluated again by blood routine review on the morning of the second day after transfusion.

   Indications for postoperative blood transfusion: No blood transfusion for Hb up to 8g/L or above; Hb up to 7g/L (including) must be transfused; Hb is between 7-8g/L, and blood transfusion should be given when anemia symptoms such as dizziness, weakness, palpitation, etc.

6. Postoperative complication [ Time Frame: 3 years postoperatively ]
   The postoperative complications such as wound nonunion, wound infection, hematomas and anemia were recorded.
7. Rotation Angle of femur prosthesis [ Time Frame: Postoperative day 3 ]
   On the horizontal plane of CT scan of the affected knee, the Angle between the line of the posterior condyle of the femoral prosthesis and the line of the transcondyle of the femur was shown. The target Angle was defined as 0° external rotation of the femoral prosthesis, positive Angle during external rotation, negative Angle during internal rotation, acceptable range of ±2°, beyond which was defined as angular deviation
8. Visual analogue scale [ Time Frame: Postoperative day 3 ]
   The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
9. Visual analogue scale [ Time Frame: 2 weeks postoperatively ]
   The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
10. Visual analogue scale [ Time Frame: 6 weeks postoperatively ]
    The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
11. Visual analogue scale [ Time Frame: 3 months postoperatively ]
    The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
12. Visual analogue scale [ Time Frame: 6 months postoperatively ]
    The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
13. Visual analogue scale [ Time Frame: 12 months postoperatively ]
    The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
14. Visual analogue scale [ Time Frame: 24 months postoperatively ]
    The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
15. Visual analogue scale [ Time Frame: 36 months postoperatively ]
    The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
16. Range of motion [ Time Frame: 3 days postoperatively ]
    The Range of motion of the knee on the operative side of the patient was measured
17. Range of motion [ Time Frame: 2 weeks postoperatively ]
    The Range of motion of the knee on the operative side of the patient was measured
18. Range of motion [ Time Frame: 6 weeks postoperatively ]
    The Range of motion of the knee on the operative side of the patient was measured
19. Range of motion [ Time Frame: 3 months postoperatively ]
    The Range of motion of the knee on the operative side of the patient was measured
20. Range of motion [ Time Frame: 6 months postoperatively ]
    The Range of motion of the knee on the operative side of the patient was measured
21. Range of motion [ Time Frame: 12 months postoperatively ]
    The Range of motion of the knee on the operative side of the patient was measured
22. Range of motion [ Time Frame: 24 months postoperatively ]
    The Range of motion of the knee on the operative side of the patient was measured
23. Range of motion [ Time Frame: 36 months postoperatively ]
    The Range of motion of the knee on the operative side of the patient was measured
24. knee society score [ Time Frame: 6 weeks postoperatively ]
    This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
25. knee society score [ Time Frame: 3 months postoperatively ]
    This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
26. knee society score [ Time Frame: 6 months postoperatively ]
    This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
27. knee society score [ Time Frame: 12 months postoperatively ]
    This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
28. knee society score [ Time Frame: 24 months postoperatively ]
    This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
29. knee society score [ Time Frame: 36 months postoperatively ]
    This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
30. Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: 6 weeks postoperatively ]
    This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
31. Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: 3 months postoperatively ]
    This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
32. Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: 6 months postoperatively ]
    This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
33. Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: 12 months postoperatively ]
    This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
34. Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: 24 months postoperatively ]
    This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
35. Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: 36 months postoperatively ]
    This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
36. Patient satisfaction [ Time Frame: 6 months postoperatively ]
    At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
37. Patient satisfaction [ Time Frame: 12 months postoperatively ]
    At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
38. Patient satisfaction [ Time Frame: 24 months postoperatively ]
    At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
39. Patient satisfaction [ Time Frame: 36 months postoperatively ]
    At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
40. Length of stay [ Time Frame: an average of 3 days postoperatively ]
    The number of days a patient stays in hospital from admission to discharge
41. Medical expenses [ Time Frame: an average of 3 days postoperatively ]
    The total cost of a patient from admission to discharge

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing knee replacement in our hospital

Criteria

Inclusion Criteria:

• a. primary knee osteoarthritis;
• b. Unilateral primary knee replacement;
• c. Surgical methods were traditional surgery, surgical robot, computer navigation or personalized osteotomy guide

Exclusion Criteria:

• a. A history of renal insufficiency (Cr > 2.5), liver insufficiency, severe heart disease (or coronary stenting within the last 12 months), severe respiratory disease, history of VTE or high risk of thrombosis (hereditary/acquired thrombotic disease), cotting disorder, stroke, and malignancy;
• b. Those who do not accept this test for any reason and refuse to sign the informed consent.

Contacts and Locations

Contacts

Contact: Tian Hua, MD; 86-13511065187; tianhua@bjmu.edu.cn

Contact: Zheng Yuhang, MD; 86-18811185091; 1710301104@pku.edu.cn

Locations

China, Beijing

Peking University Third Hospital; Recruiting

Beijing, Beijing, China, 100181

Contact: Tian Hua, MD 86-18211070116 tianhua@bjmu.edu.cn

Contact: Zheng Yuhang, bachelor 86-18811185091 1710301104@pku.edu.cn

Sponsors and Collaborators

Tian Hua

Investigators

• Study Director: Tian Hua, MD; Director

More Information

• Responsible Party: Tian Hua, archiater, Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT06010979
• Other Study ID Numbers: TKAcohort
• First Posted: August 25, 2023
• Last Update Posted: August 25, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: It will be published as an academic paper
• Supporting Materials: Study Protocol; Clinical Study Report (CSR)
• Time Frame: When data collection is complete
• Access Criteria: All the researchers who need it

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

Keywords provided by Tian Hua, Peking University Third Hospital:

total knee arthroplasty; knee osteoarthritis; computer navigation; robotic system; patient-spercific instrumentation

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases