Knee Osteoarthritis
Conditions
Keywords
knee osteoarthritis, high tibial osteotomy, medial collateral ligament, fracture healing
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.
Interventions
PROCEDUREOWHTO
OWHTO Surgical procedure For the OWHTO Surgical procedure, only medial split biplanar osteotomy performed.
PROCEDURECWHTO
CWHTO Surgical procedure For the OWHTO Surgical procedure, only lateral closure osteotomy was performed.
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Whereas patients and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period.
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Visual Analog Scale score | Baseline | Assess pain on a scale of 0 (no pain) to 10 (worst possible pain). |
| Radiological evaluation | Baseline | Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA) |
| WOMAC | Baseline | 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 hospital for surgery score | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | Postoperative 3 day | Intraoperative blood loss, operation time, postoperative drainage, incidence of thrombosis, postoperative nerve damage |
Countries
China
Outcome results
None listed