SP26. Efficacy of Microfragmented Adipose Tissue for Treatment of Symptomatic Knee Osteoarthritis: A Randomized, Placebo-controlled Study
Bibliographic record
Abstract
PURPOSE: Knee osteoarthritis (OA) is a debilitating joint disorder affecting tens of millions of people worldwide. Nonoperative treatment options have variable efficacy and none stop or reverse the progression of OA. Furthermore, there is a lack of literature supporting the efficacy of intra-articular corticosteroids, one of the most common treatment options. The purpose of this study is to evaluate pain relief and functional improvement after knee OA treatment with a novel therapeutic intervention, microfragmented adipose tissue, in comparison to a saline placebo and gold-standard corticosteroid injections. METHODS: Patients with radiographic knee OA, a minimum pain score of 3 on the visual analog scale (VAS), and no prior knee injection were eligible for inclusion. Patients were randomized to one of three treatment groups: microfragmented adipose tissue (MFAT), corticosteroid (CS), or saline placebo (P) injection. Both the practitioner and patient were blinded to the injection in the CS and P groups. A sham liposuction procedure was not performed. For the MFAT group, both an orthopaedic surgeon and plastic surgeon performed the lipoaspiration portion together under local anesthesia. The VAS pain scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Knee Injury and Osteoarthritis Outcome Score scale (KOOS) were recorded pre-procedure and at specified time points post-procedure up to one year. RESULTS: A total of 75 patients have been enrolled and randomized to the three treatment groups. A statistical analysis of these 75 patients was completed to compare post-procedure outcomes to pre-procedure pain and functionality. The WOMAC score showed significant improvement of the MFAT group at 1 year follow-up, compared CS and P groups (p = 0.01). The KOOS pain score improved in the MFAT group at 1 year follow-up, compared to the CS and the P groups (p=0.01). VAS scores improved across all groups, however did not reach statistical significance. When a linear mixed effects model was used to quantify changes in outcomes over the 1 year post-procedure period, the MFAT group demonstrated a consistently positive improvement across all five outcomes measures, whereas no consistent trend was noted in the P group and a negative trend was noted in the CS group after the initial 2 week improvement. Patients with more severe radiographic knee OA had poorer outcome scores in all groups. No complications were noted in any of the study patients with the exception of mild expected donor site morbidity of minor pain and ecchymosis in the MFAT group. CONCLUSIONS: Nonoperative knee OA treatment options are limited with variable efficacy. It is critical to evaluate patient outcomes rigorously prior to instituting novel procedures or treatments. The data from this study indicate that patients undergoing microfragmented adipose tissue injections consistently demonstrate the largest improvement in outcome scores at 6-12-month follow-up compared with the placebo and corticosteroid groups. In addition, the patients are continuing to trend towards greater improvement at the 1-year time point.
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| 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) | 0.000 | 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".