M G M Schotanus1, P Pilot2, B L Kaptein3, W F Draijer4, P B J Tilman4, R Vos5, N P Kort4. 1. Department of Orthopaedic Surgery, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands. martijnschotanus@hotmail.com. 2. Department of Orthopaedic Surgery, Reinier de Graafweg Hospital, Delft, The Netherlands. 3. Department of Orthopaedic Surgery, Leiden University Medical Center, Leiden, The Netherlands. 4. Department of Orthopaedic Surgery, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands. 5. Department of Methodology and Statistics, Maastricht University Medical Center, Maastricht, The Netherlands.
Abstract
PURPOSE: A concern that arises with any new prosthesis is whether it will achieve satisfactory long-term implant stability. The gold standard of assessing the quality of fixation in a new or relatively new implant is to undertake a randomized controlled trial using radiostereometric analysis. It was hypothesized that both mobile-bearing total knee arthroplasty and fixed-bearing total knee arthroplasty have comparable migration patterns at 2-year follow-up. This study investigated two types of cemented total knee arthroplasty, the mobile- or fixed-bearing variant from the same family with use of radiostereometric analysis. METHODS: This prospective, patient-blinded, randomized, controlled trial was designed to investigate early migration of the tibia component after two years of follow-up with use of radiostereometric analysis. A total of 50 patients were randomized to receive a mobile- or fixed-bearing TKA from the same family. Patients were evaluated during 2-year follow-up, including radiostereometric analysis, physical and clinical examination and patient reported outcome measures (PROMs). RESULTS: At two-year follow-up, the mean (±SD) maximum total point motion (MTPM) in the fixed-bearing group was 0.82 (±1.16) versus 0.92 mm (±0.64) in the mobile-bearing group (p = n.s) with the largest migration seen during the first 6 weeks (0.45 ± 0.32 vs. 0.54 ± 0.30). The clinical outcome and PROMs significantly improved within each group, not between both groups. CONCLUSIONS: Measuring early micromotion is useful for predicting clinical loosening that can lead to revision. The results of this study demonstrate that early migration of the mobile-bearing is similar to that of the fixed-bearing component at two years and was mainly seen in the first weeks after implantation. LEVEL OF EVIDENCE: Randomized, single-blind, controlled trial, Level I.
RCT Entities:
PURPOSE: A concern that arises with any new prosthesis is whether it will achieve satisfactory long-term implant stability. The gold standard of assessing the quality of fixation in a new or relatively new implant is to undertake a randomized controlled trial using radiostereometric analysis. It was hypothesized that both mobile-bearing total knee arthroplasty and fixed-bearing total knee arthroplasty have comparable migration patterns at 2-year follow-up. This study investigated two types of cemented total knee arthroplasty, the mobile- or fixed-bearing variant from the same family with use of radiostereometric analysis. METHODS: This prospective, patient-blinded, randomized, controlled trial was designed to investigate early migration of the tibia component after two years of follow-up with use of radiostereometric analysis. A total of 50 patients were randomized to receive a mobile- or fixed-bearing TKA from the same family. Patients were evaluated during 2-year follow-up, including radiostereometric analysis, physical and clinical examination and patient reported outcome measures (PROMs). RESULTS: At two-year follow-up, the mean (±SD) maximum total point motion (MTPM) in the fixed-bearing group was 0.82 (±1.16) versus 0.92 mm (±0.64) in the mobile-bearing group (p = n.s) with the largest migration seen during the first 6 weeks (0.45 ± 0.32 vs. 0.54 ± 0.30). The clinical outcome and PROMs significantly improved within each group, not between both groups. CONCLUSIONS: Measuring early micromotion is useful for predicting clinical loosening that can lead to revision. The results of this study demonstrate that early migration of the mobile-bearing is similar to that of the fixed-bearing component at two years and was mainly seen in the first weeks after implantation. LEVEL OF EVIDENCE: Randomized, single-blind, controlled trial, Level I.
Entities:
Keywords:
Fixed bearing; Migration; Mobile bearing; RSA; Stereophotogrammetric analysis; Total knee arthroplasty
Authors: Eric H Garling; Mirjam van Eck; Tessa Wedding; Dirk-Jan Veeger; Edward R Valstar; Rob G H H Nelissen Journal: Knee Date: 2005-06 Impact factor: 2.199