Rotator Cuff Failure With Continuity
NCT: NCT02716441 · ACTIVE_NOT_RECRUITING
Brief Summary
This proposal's objective is to challenge and expand the current definition of rotator cuff healing by investigating tendon retraction - broadly defined as medial translation of the repaired tendon away from the bone with or without a defect - as a common and clinically predictive structural outcome following rotator cuff repair. The investigators' central hypothesis is that failure with continuity is a common yet unrecognized structural phenomenon of rotator cuff healing that is significantly and meaningfully correlated with clinical outcomes. The investigators' approach is to characterize tendon retraction using an array of implanted radio-opaque markers, and investigate its relationship to pre-operative tissue quality (MRI), post-operative repair structural integrity (MRI) and clinical outcomes in a 125-patient prospective cohort study. These patients will complete (1) validated questionnaires and range of motion testing pre-operatively, (2) CT imaging at day of surgery, 3 weeks, 3 and 6 months, and 1, 2 and 5 years post-operatively, (3) MRI at 3 weeks, 3 and 6 months, and 1, 2 and 5 years post-operatively and (4) questionnaires, range of motion and strength testing at 3 and 6 months and 1, 2 and 5 years post-operatively.
Frequently Asked Questions
What is Rotator Cuff Failure With Continuity?
Rotator Cuff Failure With Continuity is a clinical trial registered under NCT02716441. Current status: ACTIVE_NOT_RECRUITING.
What is the status of NCT02716441?
The current status of NCT02716441 (Rotator Cuff Failure With Continuity) is: ACTIVE_NOT_RECRUITING.
When did Rotator Cuff Failure With Continuity start?
Rotator Cuff Failure With Continuity started on 2016-09.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.