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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: CWHTO; Procedure: OWHTO

• Registration Number: NCT05382429
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-12-20
• Status Verified: 2022-05
• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-18
• Last Update Submitted: 2022-05-18
• Study First Posted: 2022-05-19
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CWHTO	CWHTO	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
OWHTO	OWHTO	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.

Primary Outcome Measures

Name	Time	Method
The hospital for surgery score	Postoperative 18 months	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.
WOMAC	Postoperative 18 months	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.
The Visual Analog Scale score	Postoperative 18 months	Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Radiological evaluation	Postoperative 18 months	Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA)

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	Postoperative 3 months	Intraoperative blood loss, operation time, postoperative drainage, incidence of thrombosis, postoperative nerve damage

Trial Locations

Locations (1)

Jinli Chen; 🇨🇳 Qingdao, Shandong, China