THA With Delta Ceramic on Ceramic: Results of a Multicenter Investigational Device Exemption Trial
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
UNLABELLED: Although the published studies on the outcomes of total hip arthroplasty (THA) performed with currently available ceramic components show high survivorship and low bearing wear at midterm followup, concern over ceramic fracture and squeaking persist. For these reasons, the use of ceramic is limited. Recently, a new alumina matrix composite material (Delta ceramic) with improved material properties was developed to address these concerns. We report the early outcomes and complications of a prospective, randomized, multicenter trial of 263 patients (264 hips) at eight centers, comparing a Delta ceramic-on-ceramic (COC) articulation with a Delta ceramic head-crosslinked polyethylene bearing combination (COP). There were 177 COC hips and 87 COP hips. Complications were reported for all patients, whereas clinical and radiographic results were provided for the 233 patients with minimum 2-year followup (average, 31.2 months; range, 21-49 months). The Harris hip scores and clinical, radiographic, and survivorship outcomes were similar in both groups. There were four (2%) revisions in the COC group and two (2%) in the COP group. We encountered three intraoperative ceramic liner-related events. In addition, one patient receiving the COC underwent revision for chipping of the ceramic liner, and a second had ceramic fragmentation on followup radiographs but has not undergone revision. These liner related complications remain a concern. No patient reported squeaking in either group; this leaves us hopeful the new material will lessen the frequency of squeaking. In the short term, the Delta COC articulation provided similar functional scores and survivorship and complication rates with the ceramic head mated with crosslinked polyethylene. LEVEL OF EVIDENCE: Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.002 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 it