MINIMUM THREE YEAR FOLLOW-UP OF A DOUBLE BLIND RCT COMPARING MOBILE AND FIXED BEARING DEVICES

D.J. Beard; D.W. Murray; H. Pandit; C.A.F. Dodd; A. Price; A. Butler-Manuel; J.W. Goodfellow

doi:10.1302/0301-620X.87BSUPP_II.0870147b

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MINIMUM THREE YEAR FOLLOW-UP OF A DOUBLE BLIND RCT COMPARING MOBILE AND FIXED BEARING DEVICES

D.J. Beard
D.W. Murray
H. Pandit
C.A.F. Dodd
A. Price
A. Butler-Manuel
J.W. Goodfellow

MINIMUM THREE YEAR FOLLOW-UP OF A DOUBLE BLIND RCT COMPARING MOBILE AND FIXED BEARING DEVICES

Beard D, Murray D, Pandit H, et al. MINIMUM THREE YEAR FOLLOW-UP OF A DOUBLE BLIND RCT COMPARING MOBILE AND FIXED BEARING DEVICES. Orthop Procs. 2005;87-B(SUPP_II):147-147. doi:10.1302/0301-620X.87BSUPP_II.0870147b

Beard, D.J., et al. “MINIMUM THREE YEAR FOLLOW-UP OF A DOUBLE BLIND RCT COMPARING MOBILE AND FIXED BEARING DEVICES.” Orthopaedic Proceedings, vol. 87-B, no. SUPP_II, 2005, pp. 147-147., https://doi.org/10.1302/0301-620X.87BSUPP_II.0870147b

Beard, D., Murray, D., Pandit, H., Dodd, C., Price, A., Butler-Manuel, A., & Goodfellow, J. (2005). MINIMUM THREE YEAR FOLLOW-UP OF A DOUBLE BLIND RCT COMPARING MOBILE AND FIXED BEARING DEVICES. Orthopaedic Proceedings, 87-B(SUPP_II), 147-147. https://doi.org/10.1302/0301-620X.87BSUPP_II.0870147b

Beard, D., Murray, D., Pandit, H., Dodd, C., Price, A., Butler-Manuel, A. et al. (2005) “MINIMUM THREE YEAR FOLLOW-UP OF A DOUBLE BLIND RCT COMPARING MOBILE AND FIXED BEARING DEVICES.” Orthopaedic Proceedings, 87-B(SUPP_II), pp. 147-147. Available at: https://doi.org/10.1302/0301-620X.87BSUPP_II.0870147b

Beard, D.J., D.W. Murray, H. Pandit, C.A.F. Dodd, A. Price, A. Butler-Manuel, and J.W. Goodfellow. “MINIMUM THREE YEAR FOLLOW-UP OF A DOUBLE BLIND RCT COMPARING MOBILE AND FIXED BEARING DEVICES.” Orthopaedic Proceedings 87-B, no. SUPP_II (2005): 147-147. https://doi.org/10.1302/0301-620X.87BSUPP_II.0870147b

Beard D, Murray D, Pandit H, Dodd C, Price A, Butler-Manuel A, et al. MINIMUM THREE YEAR FOLLOW-UP OF A DOUBLE BLIND RCT COMPARING MOBILE AND FIXED BEARING DEVICES. Orthop Procs. 2005 Apr 1;87-B(SUPP_II):147-147. https://doi.org/10.1302/0301-620X.87BSUPP_II.0870147b

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Abstract

Introduction and Aims A randomised controlled trial (RCT) and a multi-centre unilateral cohort study were performed as part of the stepwise introduction of a new mobile bearing knee. The aim was to ensure that outcome for the new device was at least as good as that for an established fixed bearing device. This paper presents three year follow up of the published one year results. Instability and prevalence of “clicking” from the joint were examined in detail.

Method 1. A multi-centre RCT of patients undergoing bilateral knee replacement compared functional outcome between two different prostheses, the new mobile bearing device (TMK) and an established fixed bearing device (AGC). 2. A separate multi-centre cohort of 166 patients who had undergone a unilateral mobile bearing procedure at least six months previously was used to assess complication rate and corroborate any findings from the bilateral trial. Outcome measures included Oxford Knee Scores, American Knee Society ratings and complication rate.

Results The bilateral trial revealed no significant differences in outcome between the two devices. Revision rate for all (199) mobile bearing knees was less than 2%. The mean Oxford Knee Score for outcome for all mobile bearing knees was 37.1 ± 10.1. About 7% of patients reported instability. Clicking was more common in the TMK (48%) than in the AGC (30%) and was reported as a problem in 16% of TMK’s in the cohort study. However, clicking was unrelated to outcome score in both studies.

Conclusion At three years, the mobile bearing device was as good as the fixed bearing device. There was a relatively high prevalence of “clicking” in the TMK but the cause remains unclear. Furthermore, the symptom was not associated with poor functional outcome. The bilateral RCT and cohort study allows assessment of function and potential problems. It provides rigourous scientific justification for the introduction and early assessment of new implants.

Correspondence should be addressed to Roger Smith, Honorary Secretary, BASK c/o Royal College of Surgeons, 35 – 43 Lincoln’s Inn Fields, London WC2A 3PN