InSpace Implant Compared with Partial Repair for the Treatment of Full-Thickness Massive Rotator Cuff Tears
Bibliographic record
Abstract
BACKGROUND: The purpose of this study was to prospectively evaluate the efficacy and safety of a subacromial balloon spacer (InSpace implant; Stryker) compared with arthroscopic partial repair in patients with irreparable, posterosuperior massive rotator cuff tears. METHODS: Patients ≥40 years of age with symptomatic, irreparable, posterosuperior, massive rotator cuff tears and an intact subscapularis who underwent failed nonoperative management were included in this randomized controlled trial comparing the InSpace implant with partial repair. Clinical outcome data were collected at baseline through a 24-month follow-up. The primary outcome was improvement in the American Shoulder and Elbow Surgeons (ASES) scores. The secondary outcomes included change from baseline in the Western Ontario Rotator Cuff (WORC) score, the visual analog scale (VAS) pain score, the Constant-Murley shoulder score, the EuroQol-5 Dimensions-5-Level (EQ-5D-5L) score, active range of motion, and operative time. Complications and reoperations for each group were also recorded. RESULTS: Twenty sites randomized 184 patients: 93 in the InSpace group and 91 in the partial repair group. Significant and clinically relevant improvements in the ASES score from baseline were noted in both groups at Month 12 and were maintained at Month 24. Overall, 83% of patients in the InSpace group and 81% of patients in the partial repair group achieved the ASES minimally clinically important difference threshold, and 82% of patients in the InSpace group and 79% of patients in the partial repair group achieved the substantial clinical benefit threshold. Forward elevation was significantly greater in the InSpace group compared with the partial repair group at Day 10 (p = 0.04), Week 6 (p = 0.0001), Month 12 (p = 0.005), and Month 24 (p = 0.003). The operative time was significantly shorter in the InSpace group (p < 0.0001). No device-related surgical complications were noted, and 4 reoperations after InSpace implantation and 3 reoperations after partial repair were required. CONCLUSIONS: The InSpace implant is an appropriate alternative to partial repair in patients with irreparable posterosuperior massive rotator cuff tears and an intact subscapularis. Notable benefits include early functional recovery and pain relief combined with a shorter operative time. LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.
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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 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".