Vertebroplasty in the Treatment of Acute Fracture (VITTA) Trial (P3.389)
Bibliographic record
Abstract
Objective: to compare vertebroplasty with a control procedure (facet block) Background: vertebroplasty for acute fracture is widely offered for pain reduction. No good quality randomized evidence exists to support its indication and efficacy. Design: The VITTA trial is a randomized, controlled, single-blinded, cross-over care trial comparing percutaneous vertebroplasty with facet block in patients with acute (< 30 days) and painful vertebral compression fractures. Inclusion criteria are: adults with at least one and at most two acute VCFs caudate to T4 and physical examination showing axial back pain likely secondary to the VCF with restricted mobilization. Exclusion criteria are: Recent (<30 days) major surgery causing debilitating pain. At initiation, the trial will roll-out as a single-center pilot study of 50 patients in order to assess the acceptability of the trial, the feasibility of recruitment, and the reproducibility of the outcome scale used as primary endpoint. Patients in the control arm will receive facet block at the affected level. The primary hypothesis is that patients assigned to vertebroplasty will have a 30[percnt] higher chance of reaching a better functional outcome within 15 days as compared to patients receiving facet block. The primary endpoint is achieving a score ≥75 on the Barthel Index (BI) score at 15 days. The total number of patients to be recruited is 495. Patients will be offered a blinded cross-over to the opposite arm at 15 days. Follow-up is for a total of 30 days. Secondary endpoints include rates of cross-over at 15 days, pain levels at 15 and 30 days, BI and type of dwelling at 30 days. Results: VITTA started enrolling patient in the pilot phase at one center. The investigators are seeking interested interventional neurologist willing to participate in the trial. Financial support: VITTA trial as a pragmatic investigator lead care trial with no sponsor.
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.010 | 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".