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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Surgery Versus No Surgery for Osteoarthritis (OA) of the Knee

NCT00562822

Osteoarthritis of the Knee

COMPLETED PHASE3

Intelligent Precision Knee Preservation System for Knee Osteoarthritis

NCT07284524

Knee Osteoarthritis (Knee OA)

NOT_YET_RECRUITING NA

The Effect of Lateral Wedge Insole for Knee Osteoarthritis Patient in Plantar Pressure, Quadriceps Thickness, Gait and Walking Speed

NCT04629040

Osteoarthritis, Knee

UNKNOWN NA

Effect of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women

NCT05529446

Non Specific Knee Osteoarthritis Pain

COMPLETED NA

Tong-Luo-Qu-Tong Plaster for KOA: a Randomised, Double-blind, Parallel Positive Control, Multi-center Clinical Trial

NCT03309501

Knee Osteoarthritis Chronic Musculoskeletal Disease

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Whereas patients and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

OWHTO

Intervention Type PROCEDURE

OWHTO Surgical procedure For the OWHTO Surgical procedure, only medial split biplanar osteotomy performed.

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

Group Type EXPERIMENTAL

CWHTO

Intervention Type PROCEDURE

CWHTO Surgical procedure For the OWHTO Surgical procedure, only lateral closure osteotomy was performed.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OWHTO

OWHTO Surgical procedure For the OWHTO Surgical procedure, only medial split biplanar osteotomy performed.

Intervention Type PROCEDURE

CWHTO

CWHTO Surgical procedure For the OWHTO Surgical procedure, only lateral closure osteotomy was performed.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No