Abstract
The trabecular metal Monoblock TKR is comprised of a porous tantalum base plate with the polyethylene liner embedded directly in the porous metal. An alternative design, the trabecular metal Modular TKR, allows polyethylene liner insertion into the locking base plate after base plate implantation, but removes the low modulus of elasticity that was inherent in the Monoblock design. The purpose of this study was to compare the fixation of the Monoblock and Modular trabeucular metal base plates in a randomised controlled trial.
Fifty subjects (30 female) were randomly assigned to receive the uncemented trabecular metal Monoblock or uncemented trabecular metal Modular knee replacement. A standard procedure of tantalum marker insertion in the proximal tibial and polyethylene liner was followed with uniplanar radiostereometric analysis (RSA) examinations immediately post-operatively and at 6 week, 3 month, 6 month, and 12 month follow-ups. The study was approved by the Research Ethics Board and all subjects signed an Informed Consent Form.
Twenty-one subjects received Monoblock components and 20 received Modular components. An intra-operative decision to use cemented implants occurred in 5 cases and 4 subjects did not proceed to surgery after enrollment. The clinical precision of implant migration measured as maximum total point motion (MTPM) was 0.13 mm (upper limit of 95% confidence interval of double exams). Implant migration at 12 months was 0.88 ± 0.64 mm (mean and standard deviation; range 0.21 – 2.84 mm) for the Monoblock group and 1.60 ± 1.51 mm (mean and standard deviation; range 0.27 – 6.23 mm) for the Modular group. Group differences in 12 month migration approached clinical significance (p = 0.052, Mann Whitney U-test).
High early implant migration is associated with an increased risk for late aseptic loosening. Although not statistically significant, the mean migration for the Modular component group was nearly twice that of the Monoblock, which places it at the 1.6 mm threshold for “unacceptable” early migration (Pijls et al 2012). This finding is concerning in light of the recent recall of a similar trabecular metal modular knee replacement and adds validity to the use of RSA in the introduction of new or modified implant designs.
Reference: Pijls, B.G., et al., Early migration of tibial components is associated with late revision: a systematic review and meta-analysis of 21,000 knee arthroplasties. Acta Orthop, 2012. 83(6): p. 614–24.
