Observation of the Clinical Efficacy of Two Surgical Procedures for Varus Knee Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this study is to conduct a prospective randomized controlled trial to compare the effects between two surgical procedures in the treatment of varus knee osteoarthritis.The hypothesis was that there would be no difference in mechanical axis correction between two surgical procedures.

Detailed Description
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This was a single-center, prospective, double-blinded, randomized controlled trial, comparing two surgical procedures in the treatment of varus knee osteoarthritis. Participants were recruited from September 2019 to September 2021. Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. Whereas participants and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period. Operations were performed by the same team of sports medicine surgeons under general anesthesia.For the open wedge high tibial osteotomy group, Those who were randomly assigned to the OWHTO group, OWHTO Surgical procedure will be performed. For the closing wedge high tibial osteotomy group, hose who were randomly assigned to the CWHTO group, CWHTO Surgical procedure will be performed. The sample size calculation was based on data from previous studies. Accepting an α risk of 0.05 and a β risk of 0.2 in a bilateral contrast, the minimum sample size required for each group was 35. To compensate for an estimated 15% loss to follow up, at least 82 patients would be included.

Official Title
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Official Title:Observation of the Clinical Efficacy of Two Surgical Procedures on the Short-term Outcome of Moderate Varus Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: OWHTO
* Procedure: CWHTO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The eligibility criteria for HTO were spontaneous osteonecrosis of the knee of the medial femoral condyle, medial compartment OA, Ahlbäck grades 1 or 2, femorotibial angle (FTA) of ≤185, flexion contracture of ≤15° , lack of damage to the anterior cruciate ligament (ACL) and posterior cruciate ligament, and no age restrictions . Exclusion Criteria: Congenital deformity of knee joint, severe rheumatoid arthritis, Charkoff's joint, injury of knee joint (injury of medial and lateral collateral ligament, patella fracture, etc.) or surgical history (meniscectomy, femoral or tibial fracture after surgery), large number of free bodies or soft tissue flexion contracture in the joint >10º, and range of motion of knee joint <100º.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. According to preoperative allocation, the patients were given open wedge high tibial osteotomy or closingwedge high tibial osteotomy.For the open wedge high tibial osteotomy group, Those who were randomly assigned to the OWHTO group, OWHTO Surgical procedure will be performed.For the closing wedge high tibial osteotomy group, hose who were randomly assigned to the CWHTO group, CWHTO Surgical procedure will be performed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OWHTO<br>open wedge high tibial osteotomy group For the open wedge high tibial osteotomy group, Those who were randomly assigned to the OWHTO group, OWHTO Surgical procedure will be performed. | Procedure: OWHTO<br>* OWHTO Surgical procedure For the OWHTO Surgical procedure, only medial split biplanar osteotomy performed.<br>|
| Experimental: CWHTO<br>closing wedge high tibial osteotomy group For the closing wedge high tibial osteotomy group, hose who were randomly assigned to the CWHTO group, CWHTO Surgical procedure will be performed | Procedure: CWHTO<br>* CWHTO Surgical procedure For the OWHTO Surgical procedure, only lateral closure osteotomy was performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Visual Analog Scale score | Assess pain on a scale of 0 (no pain) to 10 (worst possible pain). | Baseline | 
| The Visual Analog Scale score | Assess pain on a scale of 0 (no pain) to 10 (worst possible pain). | Postoperative 6 months | 
| The Visual Analog Scale score | Assess pain on a scale of 0 (no pain) to 10 (worst possible pain). | Postoperative 12 months | 
| The Visual Analog Scale score | Assess pain on a scale of 0 (no pain) to 10 (worst possible pain). | Postoperative 18 months | 
| Radiological evaluation | Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA) | Baseline | 
| Radiological evaluation | Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA) | Postoperative 6 months | 
| Radiological evaluation | Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA) | Postoperative 12 months | 
| Radiological evaluation | Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA) | Postoperative 18 months | 
| WOMAC | This score evaluates the structure and function of the knee joint from three aspects of pain, stiffness and physical function, covering the basic symptoms and signs of the whole OA. The lower the score, the better the functional status of the patient.WOMAC score < 21 is mild, 21 to 48 is moderate, > 48 is classified as severe. | Baseline | 
| WOMAC | This score evaluates the structure and function of the knee joint from three aspects of pain, stiffness and physical function, covering the basic symptoms and signs of the whole OA. The lower the score, the better the functional status of the patient.WOMAC score < 21 is mild, 21 to 48 is moderate, > 48 is classified as severe. | Postoperative 6 months | 
| WOMAC | This score evaluates the structure and function of the knee joint from three aspects of pain, stiffness and physical function, covering the basic symptoms and signs of the whole OA. The lower the score, the better the functional status of the patient.WOMAC score < 21 is mild, 21 to 48 is moderate, > 48 is classified as severe. | Postoperative 12 months | 
| WOMAC | This score evaluates the structure and function of the knee joint from three aspects of pain, stiffness and physical function, covering the basic symptoms and signs of the whole OA. The lower the score, the better the functional status of the patient.WOMAC score < 21 is mild, 21 to 48 is moderate, > 48 is classified as severe. | Postoperative 18 months | 
| The hospital for surgery score | The clinical efficacy was evaluated by HSS knee function score. Items include pain, function, activity level, etc., with a total score of 0 to100, the higher the score, the better the curative effect. | Baseline | 
| The hospital for surgery score | The clinical efficacy was evaluated by HSS knee function score. Items include pain, function, activity level, etc., with a total score of 0 to100, the higher the score, the better the curative effect. | Postoperative 6 months | 
| The hospital for surgery score | The clinical efficacy was evaluated by HSS knee function score. Items include pain, function, activity level, etc., with a total score of 0 to100, the higher the score, the better the curative effect. | Postoperative 12 months | 
| The hospital for surgery score | The clinical efficacy was evaluated by HSS knee function score. Items include pain, function, activity level, etc., with a total score of 0 to100, the higher the score, the better the curative effect. | Postoperative 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Intraoperative blood loss, operation time, postoperative drainage, incidence of thrombosis, postoperative nerve damage | Postoperative 3 day | 
| Postoperative complications | Intraoperative blood loss, operation time, postoperative drainage, incidence of thrombosis, postoperative nerve damage | Postoperative 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, high tibial osteotomy, medial collateral ligament, fracture healing