Observation of the Clinical Efficacy of Two Surgical Procedures for Varus Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

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.
    

Intervention name(s): OWHTO; CWHTO
Intervention type(s): Procedure; Procedure
Intervention description(s): OWHTO Surgical procedure For the OWHTO Surgical procedure, only medial split biplanar osteotomy performed.; CWHTO Surgical procedure For the OWHTO Surgical procedure, only lateral closure osteotomy was performed.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee osteoarthritis; high tibial osteotomy; medial collateral ligament; fracture healing