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Active, Not Recruiting

NCT Number: NCT02716441

Rotator Cuff Failure With Continuity

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Tendon Retraction

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

    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.

Secondary outcomes

  1. Change in Shoulder Strength

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

    Isometric shoulder strength will be measured using a dynamometer.

  2. Change in American Shoulder and Elbow Society (ASES) Score

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

    Patient reported outcome measure

  3. Change in Pennsylvania Shoulder Score (PSS)

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

    Patient reported outcome measure

  4. Tendon Integrity

    Time frame: 1, 2 and 5 years following rotator cuff repair

    Traditional assessment of tendon repair integrity will be performed by MR imaging

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Mar 23, 2016
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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