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Trial · NCT07890831

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRotator cuff retear rate12 months postoperativelyProportion of participants with a retear on MRI, defined as Sugaya type IV or V (scale I-V; higher = worse integrity)
SecondaryMRI rotator cuff score12 monthsSum of footprint size, tendon thickness, and signal intensity, each graded 1-4 (Crim et al., 2010). Total range 3-12; 12 = normal tendon.
SecondaryFatty infiltration12 monthsGoutallier grade 0-4 (higher = more fatty infiltration)
SecondaryUltrasound repair integrity6 monthsProportion with intact repair on shoulder ultrasound
SecondaryASES scoreBaseline, 6 wk, 3, 6, 12 monthsAmerican Shoulder and Elbow Surgeons score, 0-100 (higher = better)
SecondarySANE scoreBaseline, 6 wk, 3, 6, 12 monthsSingle Assessment Numeric Evaluation, 0-100% (higher = better)
SecondaryPROMIS Upper ExtremityBaseline, 6 wk, 3, 6, 12 monthsT-score, population mean 50, SD 10 (higher = better function)
SecondarySF-12Baseline, 6 wk, 3, 6, 12 monthsPhysical and Mental Component Summary scores, norm-based, mean 50 (higher = better)
SecondaryShoulder range of motionBaseline, 6 wk, 3, 6, 12 monthsForward flexion, abduction, external and internal rotation, in degrees
SecondaryShoulder strengthBaseline, 6 wk, 3, 6, 12 monthsManual muscle testing, graded 0-5
SecondaryOperative timeDay of surgeryMinutes from incision to closure

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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