Comparison of 1-mm thickness variance polyethylene insert total knee arthroplasty system and 2-mm thickness variance polyethylene insert total knee arthroplasty system in the same patients
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0006014
- Brief Summary
The purpose of this study was to compare clinical outcomes of polyethylene (PE) insert thickness between total knee arthroplasty (TKA) systems providing 1-mm and 2-mm increments. In this randomized controlled trial, 50 patients (100 knees) undergoing same-day or staggered bilateral TKA were randomized to receive a TKA system providing 1-mm increments in one knee (1-mm group) and a TKA system providing 2-mm increments in the other knee (2-mm group). At 2 years postoperatively, Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, Forgotten Joint Score (FJS), range of motion (ROM), and insert thicknesses were compared between the groups. Forty-seven patients (94 knees) participated in follow-up analysis. In each group, patient-reported outcomes improved significantly after TKA (all, P < 0.05). There were no significant differences in patient-reported outcomes. The mean ROM was not significantly different between groups at preoperative and 2-year points. The rate of postoperative flexion contracture = 5° was 2.1% and 4.3%, and the rate of postoperative recurvatum = 5° was 4.3% and 2.1% in the 1-mm group and 2-mm, respectively (all, P = 1.000). Mean insert thickness was significantly thinner in the 1-mm group than the 2-mm group (P = 0.001). The usage rate of a thick insert (= 14 mm) was 12.7% and 38.3% in the 1-mm group and 2-mm group (P = 0.005). The use of a TKA system providing 1-mm PE insert thickness increments offered no clinical benefit in terms of patient reported outcomes over systems with 2-mm increments at 2 years of follow-up. However, the TKA system with 1-mm increments showed significantly thinner PE insert usage. As a theoretical advantage of 1-mm increments has yet to be proven, the mid- to long-term effects of thinner PE insert usage must be determined.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 47
? Patients aged 19 years or older who undergo total knee arthroplasty due to osteoarthritis of the knee joint
? Patients who have the will or ability to follow doctor's instructions, including rehabilitation treatment such as joint exercise
? Patients who understand this study and consent to participation in the study
? Adult patients with osteoarthritis of the knee joint (over 19 years old)
? Patients with local infection, sepsis, neurological abnormality of the lower limb of the surgery site
? Patients with inflammatory arthritis or crystalline arthritis
? Patients with a history of surgery on one or both knees
? Patients with more than 20 degrees of preoperative flexion contracture, 15 degrees of varus deformity, 15 degrees of valgus deformation that may affect the balance of soft tissues and knee ligaments after surgery
? Patients with a range of motion of the knee joint below 90 degrees before surgery
? Highly obese patients with a body mass index of 40 or higher
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Western Ontario and McMaster Universities Index (WOMAC index)
- Secondary Outcome Measures
Name Time Method Knee Society Score;Anterior and posterior stability;Simple knee X-ray;Range of Motion of Knee;Forgotten Joint Score (FJS)