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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
Jinli Chen
Qingdao, Shandong, China
The Visual Analog Scale score
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline
The Visual Analog Scale score
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Time frame: Postoperative 6 months
The Visual Analog Scale score
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Time frame: Postoperative 12 months
The Visual Analog Scale score
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Time frame: Postoperative 18 months
Radiological evaluation
Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA)
Time frame: Baseline
Radiological evaluation
Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA)
Time frame: Postoperative 6 months
Radiological evaluation
Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA)
Time frame: Postoperative 12 months
Radiological evaluation
Items include hip-knee-ankle (HKA), the medioproximal tibial angle(MPTA) and joint line Angle retraction(JLCA)
Time frame: Postoperative 18 months
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Postoperative 18 months
Postoperative complications
Intraoperative blood loss, operation time, postoperative drainage, incidence of thrombosis, postoperative nerve damage
Time frame: Postoperative 3 day
Postoperative complications
Intraoperative blood loss, operation time, postoperative drainage, incidence of thrombosis, postoperative nerve damage
Time frame: Postoperative 3 months