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Rotator Cuff Failure With Continuity

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ClinicalTrials.gov Identifier: NCT02716441
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Kathleen Derwin, PhD, The Cleveland Clinic

Tracking Information
First Submitted Date March 15, 2016
First Posted Date March 23, 2016
Last Update Posted Date February 17, 2020
Actual Study Start Date September 2016
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 7, 2020)
Change in Tendon Retraction [ Time Frame: Day of surgery, 24 months following rotator cuff repair ]
Medial translation of the repaired tendon away from the bone between the day of surgery and 24 months following rotator cuff repair as measured by CT imaging of radio-opaque markers implanted on the tendon.
Original Primary Outcome Measures
 (submitted: March 17, 2016)
Change in Tendon Retraction [ Time Frame: Day of surgery, 24 months following rotator cuff repair ]
Medial translation of the repaired tendon away from the bone between the day of surgery and 24 months following rotator cuff repair as measured by CT imaging of radio-opaque markers implanted on the tendon and bone.
Change History
Current Secondary Outcome Measures
 (submitted: February 12, 2020)
  • Change in Shoulder Strength [ Time Frame: Day of surgery, 24 months following rotator cuff repair ]
    Isometric shoulder strength will be measured using a dynamometer.
  • Change in American Shoulder and Elbow Society (ASES) Score [ Time Frame: Day of surgery, 24 months following rotator cuff repair ]
    Patient reported outcome measure
  • Change in Pennsylvania Shoulder Score (PSS) [ Time Frame: Day of surgery, 24 months following rotator cuff repair ]
    Patient reported outcome measure
  • Tendon Integrity [ Time Frame: 24 months following rotator cuff repair ]
    Traditional assessment of tendon repair integrity will be performed by MR imaging
Original Secondary Outcome Measures
 (submitted: March 17, 2016)
  • Change in Shoulder Strength [ Time Frame: Day of surgery, 24 months following rotator cuff repair ]
    Isometric shoulder strength will be measured using a dynamometer.
  • Change in American Shoulder and Elbow Society (ASES) Score [ Time Frame: Day of surgery, 24 months following rotator cuff repair ]
  • Change in Constant Score [ Time Frame: Day of surgery, 24 months following rotator cuff repair ]
  • Change in Pennsylvania Shoulder Score (PSS) [ Time Frame: Day of surgery, 24 months following rotator cuff repair ]
  • Change in Western Ontario Rotator Cuff (WORC) Index [ Time Frame: Day of surgery, 24 months following rotator cuff repair ]
  • Tendon Integrity [ Time Frame: 24 months following rotator cuff repair ]
    Traditional assessment of tendon repair integrity will be performed by MR imaging
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rotator Cuff Failure With Continuity
Official Title Failure With Continuity and Its Relation to Rotator Cuff Repair Clinical Outcomes
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, and 3, 6, 12 and 24 months post-operatively, (3) MRI at 3 weeks and 3, 6, 12 and 24 months post-operatively and (4) questionnaires, range of motion and strength testing at 3, 6, 12 and 24 months post-operatively.
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, 6, 12 and 24 months. 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Rotator Cuff Tear
Intervention 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.
Study Groups/Cohorts Radio-opaque Tissue Markers
Patients undergoing rotator cuff repair with implantation of radio-opaque tissue markers
Intervention: Device: Radio-opaque Tissue Markers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 17, 2016)
125
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2023
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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-- defined as full thickness cartilage loss on MRI and confirmed at arthroscopy
  • Worker's compensation cases
  • Isolated subscapularis tears > 1cm
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Cathy Shemo 2164445971 shemoc@ccf.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02716441
Other Study ID Numbers 16-089
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kathleen Derwin, PhD, The Cleveland Clinic
Study Sponsor The Cleveland Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Kathleen Derwin, PhD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date February 2020