POSTERIOR DYNAMIC DISTRACTION DEVICE FOR THE TREATMENT OF ADOLESCENT IDIOPATHIC SCOLIOSIS: PRELIMINARY RESULTS FROM A PROSPECTIVE CLINICAL STUDY
Bibliographic record
Abstract
After receiving Humanitarian Use Device approval from the US FDA in 2019, a prospective study was undertaken to evaluate the safety and effectiveness of a PDDD for use in AIS. This report presents safety data for all patients treated to date and efficacy data for those with a two-year follow-up. From 13 US sites, 149 patients with AIS (Lenke 1 and 5), major Cobb 35 to 60°, less than or equal to 30° on side bending, and kyphosis less than 55°, were prospectively enrolled between June 2020 and April 2023. Demographics, safety, and deformity data were tracked. Safety and perioperative data were available for 149 patients, mean age 14.8 years and 75% female. On average, the procedure time was 112±34 min and estimated blood loss was 38.1±33.9 ml. The preoperative Cobb angle was 47.5°±7.3° with flexibility to 17.6°±6.6°. The Cobb angle at the first erect visit was 18.7°±7.0°. Mean hospitalization was 1.3 days. Two patients were admitted to the ICU for one day. Twenty-one patients (14.1%) had 23 reoperations, which included 14 PDDD revisions (9.4%) and seven PDDD removals (4.7%). Two patients were converted to posterior spinal fusion (1.3%). The main reasons included implant breakage (n=8), curve progression (n=4), infection (n=3), and screw migration or misplacement (n=3). One patient had a dural leak and was also admitted one-month post-surgery for wound irrigation and debridement. Both events resolved without sequelae. No major neurologic issues were noted. Twenty-five patients had minimum two-year follow-up, 16 of them Lenke 1 and nine Lenke 5. The subgroup characteristics were similar to the entire cohort. (Table 1). At two years, curve correction to ≤30° was noted for 92% of the cohort and was maintained at the last follow-up (P=0.629). Five of the 25 patients (20%) had revision surgery, three implant revisions and two implant removals. PDDD correction of Cobb angles was significant and durable at two-year follow-up for the majority of patients, with revision rates similar to those reported for other non-fusion scoliosis procedures and shows promise in the avoidance of spinal fusion. Ongoing study is needed to determine the true incidence of long-term complications. For any figures or tables, please contact the authors directly.
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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 | 0.001 |
| 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) | 0.000 | 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".