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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: OWHTO; Procedure: CWHTO

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266003
      • Jinli Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: OWHTO; OWHTO Surgical procedure For the OWHTO Surgical procedure, only medial split biplanar osteotomy performed.
EXPERIMENTAL: 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	Procedure: CWHTO; CWHTO Surgical procedure For the OWHTO Surgical procedure, only lateral closure osteotomy was performed.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): September 1, 2021
• Study Completion (ACTUAL): December 20, 2021

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (ACTUAL): May 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: knee osteoarthritis; high tibial osteotomy; fracture healing; medial collateral ligament
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: chenjinli

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Proposals should be directed to lichunpu2020@163.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website .
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No