Randomized Controlled Trial of a Novel Cementless <scp>vs.</scp> Cemented Total Knee Arthroplasty: Early Clinical and Radiographic Outcomes
Bibliographic record
Abstract
OBJECTIVE: Previous cementless total knee arthroplasty (TKA) designs faced challenges with insufficient initial fixation on tibial side, resulting in inferior functional outcomes and survival rates. The Zoned Trabecular Bone Cementless Knee is a novel implant designed for cementless TKA which aims to achieve excellent initial fixation, promoting effective osseointegration. The aim of this research was to compare the early clinical and radiographic results of this cementless TKA with cemented TKA. METHODS: Between September 2021 and April 2022, 64 patients (64 knees) were recruited in this prospective randomized controlled trial to receive either cementless 3D-printed trabecular metal TKA or a cemented posterior stabilized TKA. Preoperative and postoperative clinical evaluations, including the range of motion (ROM), Knee Society Score (KSS), and the Reduced Western Ontario and MacMaster Universities Score (WOMAC), were conducted and analyzed for comparison. Radiographs and computed tomography scans were utilized to assess the initial fixation. The complications between the two groups were also recorded and compared. Continuous data were analyzed for significance using independent-samples t-test or the Mann-Whitney U test and categorical data were analyzed using chi-squared or Fisher's exact test. RESULTS: Both groups demonstrated significant enhancement at 12 months follow-up in the ROM compared with baseline (ROM: 94.7 ± 23.4 vs. 113.1 ± 12.3 in cementless group and 96.5 ± 14.7 vs. 111.0 ± 12.8 in cemented group, p < 0.05). However, no statistical differences were observed between the two groups in postoperative ROM, KSS, or WOMAC score. The radiographs and computed tomography scans showed similar results, including radiolucent lines and osteolysis in either femoral or tibial. Additionally, there was no statistical difference in the overall complication rate between the two groups. Notably, one patient in the cementless TKA group required revision for periprosthetic infection as the end point. CONCLUSIONS: This novel 3D-printed trabecular metal cementless TKA achieved comparable clinical outcomes and initial fixation to cemented TKA in early stage. Longer-term examination is necessary to validate these results.
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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 | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.002 |
| 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 | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 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".