Rotator Cuff Failure With Continuity

Failure With Continuity and Its Relation to Rotator Cuff Repair Clinical Outcomes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Device: Radio-opaque Tissue Markers

Detailed Description

Currently, rotator cuff healing is defined as "intact", "attenuated", or "failed" based on the observation (or not) of a recurrent defect (i.e., a "gap") in the tendon using MRI or ultrasound imaging. The investigators' previous work has identified a new outcome, in which there is no detectable defect or "gap" in the repaired tendon, but the repaired tendon has undergone significant retraction. The investigators call this outcome "failure with continuity".

Current imaging methods are inadequate to determine the extent to which the repaired rotator cuff tendon has "failed with continuity". The investigators have developed an imaging technique to detect this phenomenon. Specifically, radio-opaque markers are sutured onto the repaired tendon. The distance between the tendon markers and the bone is measured from CT scans taken within 2 weeks of surgery, and compared to the distance measured at 3 and 6 months and 1, 2 and 5 years post-operatively. If the tendon retracts away from the bone during healing, this distance will increase over time. Healing of the tendon will also be monitored in the traditional manner by MRI scans at the same time points. The investigators will investigate the relationship between tendon retraction, MR imaging and clinical outcomes including shoulder strength and patient satisfaction.

The investigators expect to show that tendon retraction is common, occurs early post-operatively, with or without repair continuity as assessed by traditional imaging, and significantly correlates with clinical outcomes. The immediate and highly significant consequence of this finding would be a paradigm shift in the investigators' understanding of tendon repair healing, now incorporating the magnitude, timing and location of tendon retraction as well as the continuity of the repaired tissue. This information would yield a more precise understanding of rotator cuff tendon healing, allowing for advances in treatment strategies that improve surgical healing and clinical outcomes and result in more durable rotator cuff repairs over time.

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.
• Final determination of eligibility will be made at surgery when above inclusion criteria are confirmed.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radio-opaque Tissue Markers; Patients undergoing rotator cuff repair with implantation of radio-opaque tissue markers	Device: Radio-opaque Tissue Markers; All participants will undergo implantation of radio-opaque tissue markers on their repaired rotator cuff at the time of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Shoulder Strength	Isometric shoulder strength will be measured using a dynamometer.	Day of surgery and 1, 2 and 5 years following rotator cuff repair
Change in American Shoulder and Elbow Society (ASES) Score	Patient reported outcome measure	Day of surgery and 1, 2 and 5 years following rotator cuff repair
Change in Pennsylvania Shoulder Score (PSS)	Patient reported outcome measure	Day of surgery, and 1, 2 and 5 years following rotator cuff repair
Tendon Integrity	Traditional assessment of tendon repair integrity will be performed by MR imaging	1, 2 and 5 years following rotator cuff repair

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Kathleen Derwin, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimated): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 16-089 (PRMC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No