No difference in terms of radiostereometric analysis between fixed- and mobile-bearing total knee arthroplasty: a randomized, single-blind, controlled trial.
OBJECTIVE
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.


METHODS
Randomized, single-blind, controlled trial, Level I.
Department of Orthopaedic Surgery, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands. martijnschotanus@hotmail.com.
M G M
MGM
Schotanus
Department of Orthopaedic Surgery, Reinier de Graafweg Hospital, Delft, The Netherlands.
P
P
Pilot
Department of Orthopaedic Surgery, Leiden University Medical Center, Leiden, The Netherlands.
B L
BL
Kaptein
Department of Orthopaedic Surgery, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands.
W F
WF
Draijer
Department of Orthopaedic Surgery, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands.
P B J
PBJ
Tilman
Department of Methodology and Statistics, Maastricht University Medical Center, Maastricht, The Netherlands.
R
R
Vos
Department of Orthopaedic Surgery, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands.
N P
NP
Kort
D000368:Aged; D019645:Arthroplasty, Replacement, Knee / Q000295:instrumentation* / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007719:Knee Joint / Q000000981:diagnostic imaging* / Q000503:physiopathology; D007720:Knee Prosthesis; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D059869:Radiostereometric Analysis; D016037:Single-Blind Method
Fixed bearing; Migration; Mobile bearing; RSA; Stereophotogrammetric analysis; Total knee arthroplasty