Rotator Cuff Failure With Continuity

NCT02716441 | Active Not Recruiting

• 1 other identifier: 16-089
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• Change in Tendon Retraction

  Medial translation of the repaired tendon away from the bone between the day of surgery and 1, 2 and 5 years following rotator cuff repair as measured by CT imaging of radio-opaque markers implanted on the tendon.

  Day of surgery and 1, 2 and 5 years following rotator cuff repair

Secondary Outcomes (4)

• Change in Shoulder Strength

  Day of surgery and 1, 2 and 5 years following rotator cuff repair

• Change in American Shoulder and Elbow Society (ASES) Score

  Day of surgery and 1, 2 and 5 years following rotator cuff repair

• Change in Pennsylvania Shoulder Score (PSS)

  Day of surgery, and 1, 2 and 5 years following rotator cuff repair

• Tendon Integrity

  1, 2 and 5 years following rotator cuff repair

Study Arms (1)

Radio-opaque Tissue Markers

Patients undergoing rotator cuff repair with implantation of radio-opaque tissue markers

Device: Radio-opaque Tissue Markers

Interventions

Radio-opaque Tissue Markers DEVICE

All participants will undergo implantation of radio-opaque tissue markers on their repaired rotator cuff at the time of surgery.

Radio-opaque Tissue Markers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Study Population includes males and females between the ages of 18-75 who are undergoing arthroscopic rotator cuff repair surgery. Patients will be enrolled on a first come basis. No specific study demographic is necessary or desired.

You may qualify if:

• Males or females, ages 18-75 having an acute or chronic 1-5 cm wide (A-P) full thickness tear of only the supraspinatus and/or infraspinatus tendons; partial thickness tears of subscapularis or teres minor not requiring repair are allowed.
• The tear must be fully reparable arthroscopically by a double row technique.

You may not qualify if:

• Prior shoulder surgery (including rotator cuff repair)
• Symptomatic cervical spine disease
• A frozen shoulder-- defined as a loss of passive range of motion (ROM) of more than 20° in any plane compared to the contralateral shoulder,
• Glenohumeral arthritis grade 3 or 4-- defined as full thickness cartilage loss on MRI and confirmed at arthroscopy
• Worker's compensation cases
• Subscapularis tears of any size that require repair

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Kathleen Derwin, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Staff

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 23, 2016
• Study Start: September 1, 2016
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)