ONE-YEAR MIGRATION OF UNCEMENTED MONOBLOCK AND MODULAR TRABECULAR METAL TOTAL KNEE REPLACEMENTS IN A RANDOMISED CONTROLLED TRIAL
Bibliographic record
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.006 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".