Clinical trial NCT05382429: Observation of the Clinical Efficacy of Two Surgical Procedures for Varus Knee Osteoarthritis
Official title: Official Title:Observation of the Clinical Efficacy of Two Surgical Procedures on the Short-term Outcome of Moderate Varus Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
high tibial osteotomy
medial collateral ligament
fracture healing
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Visual Analog Scale score
timeFrame: Baseline
measure: The Visual Analog Scale score
timeFrame: Postoperative 6 months
measure: The Visual Analog Scale score
timeFrame: Postoperative 12 months
measure: The Visual Analog Scale score
timeFrame: Postoperative 18 months
measure: Radiological evaluation
timeFrame: Baseline
measure: Radiological evaluation
timeFrame: Postoperative 6 months
measure: Radiological evaluation
timeFrame: Postoperative 12 months
measure: Radiological evaluation
timeFrame: Postoperative 18 months
measure: WOMAC
timeFrame: Baseline
measure: WOMAC
timeFrame: Postoperative 6 months
measure: WOMAC
timeFrame: Postoperative 12 months
measure: WOMAC
timeFrame: Postoperative 18 months
measure: The hospital for surgery score
timeFrame: Baseline
measure: The hospital for surgery score
timeFrame: Postoperative 6 months
measure: The hospital for surgery score
timeFrame: Postoperative 12 months
measure: The hospital for surgery score
timeFrame: Postoperative 18 months
Secondary outcomes:
measure: Postoperative complications
timeFrame: Postoperative 3 day
measure: Postoperative complications
timeFrame: Postoperative 3 months
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Jinli Chen
state: Shandong
Study officials:
References: