10-year Follow-up of the Prospective, Double-blinded, Randomized, Controlled Study of Autologous Bone Marrow Buffy Coat Grafting Combined With Core Decompression in Patients With Avascular Necrosis of Femoral Head
Bibliographic record
Abstract
Abstract Background: Avascular necrosis of femoral head (ANFH) is a severely disabling disease of hip.Several clinical trials have shown promising outcomes on the use of mesenchymal stem cells for treatment of ANFH but long-term clinical assessment is lacking. Previously we have reported two year follow up of a prospective, double-blinded, randomized, controlled study of autologous bone marrow buffy coatgrafting combined with core decompression in patients with ANFH. Here we reported the outcome of ten year follow up on the study. Methods: We recruited 43 (53 hips) patients from 2009 to 2010. The hips were randomly allocated to code decompression (CD) with and without bone marrowbuffy coat (BBC). Participants were followed at 24, 60, 120 months postoperatively. Visual analogue scale (VAS), Lequesne algofunctional index and Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis scoring were recorded. Survival rate analysis and the prognostic factor analysis were performed. The endpoint was defined as progression to Ficat stage IV or conversion to hip arthroplasty. Results: 31 patients (41 hips) were included in the final analysis. CD + BBC group scored better in subjective assessing scores compared with CD group. The average survival time was 102.3 months and 78.1 months for CD + BBC group and CD group, respectively (Log-rank test, P = 0.029). In the univariate COX proportional-hazards regression model, age [hazards ratio (HR) = 1.079, P = 0.047] and pre-operative Ficat stage (HR = 3.283, P = 0.028) indicated high risk for progression, while the use of BBC (HR = 0.332, P = 0.042) indicated low risk. Pre-operative Ficat stage IIIwas isolated as an independent risk factor for clinical failure in the multivariate model (HR = 3.743, P = 0.018). Conclusion: The outcome of ten year follow up on this prospective, double-blinded, randomized,controlled study showed that use of the autologous BBC in combined with core decompression is more effective than core decompression alone. TrialRegistration: ClinicalTrials.gov identifier NCT01613612. Registered 13 December 2011 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/record/NCT01613612.
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How this classification was reachedexpand
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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.005 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| 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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, 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".