An implantable shock absorber yields an 85% survival‐from‐arthroplasty rate through 5 years in working‐age patients with medial compartment knee osteoarthritis
Bibliographic record
Abstract
PURPOSE: To evaluate the 5-year rate of survival without undergoing arthroplasty or high tibial osteotomy (HTO) in subjects with mild-to-moderate medial compartment knee osteoarthritis (OA) who were treated with an implantable shock absorber (ISA) system. METHODS: Three prospective, sequential, multicenter, international, single-arm clinical trials were conducted comprising subjects who received an ISA for symptomatic medial knee OA after failing ≥ 6 months of conservative therapy. Study outcomes were analyzed cumulatively and by enrollment group when all subjects' follow-up data exceeded the 2-year threshold after ISA implantation. Primary outcome was survival rate without conversion to arthroplasty/HTO. Secondary outcomes were changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores after ISA implantation. RESULTS: , 38% female; study knee Kellgren-Lawrence score 2.7 ± 0.9 points) were followed for a minimum of 2, and up to 5, years after device implantation. Overall, 90.6% (155/171) of subjects survived without requiring arthroplasty/HTO at last follow-up (mean 3.2 ± 1.6 years). The Kaplan-Meyer median 3- and 5-year survival-without-arthroplasty point estimates were 89.8% (95% CI 86.5‒95.7%) and 84.9% (95% CI 75.1‒91.1%), respectively. The median 3-year estimated survival rate for the most recent study (n = 81) was 97.3%. The mean WOMAC Pain score decreased 71% from baseline to last follow-up after ISA implantation, from 58 ± 13 to 16 ± 17 points (p < 0.0001). The Function score improved 69%, decreasing from 56 ± 18 to 17 ± 17 points (p < 0.0001). CONCLUSIONS: In younger patients with mild-to-moderate symptomatic medial compartment knee OA, implantation of the ISA device resulted in a 5-year survival rate of 85% from undergoing arthroplasty or HTO. The ISA system may be an effective treatment option for working-age patients with medial knee OA who are not candidates for or do not desire more invasive surgical approaches. LEVEL OF EVIDENCE: II.
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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 | 0.002 | 0.003 |
| 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 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 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 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".