The Affiliated Hospital of Qingdao University
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.
Knee Osteoarthritis
OWHTO
CWHTO
NA
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 |
| Estimated Enrollment : | 160 participants |
| Masking : | SINGLE |
| 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. |
| Primary Purpose : | TREATMENT |
| Official Title : | Official Title:Observation of the Clinical Efficacy of Two Surgical Procedures on the Short-term Outcome of Moderate Varus Knee Osteoarthritis |
| Actual Study Start Date : | 2019-09-01 |
| Estimated Primary Completion Date : | 2021-09-01 |
| Estimated Study Completion Date : | 2021-12-20 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 40 Years to 70 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Jin Li Chen
Qingdao, Shandong, China, 266003