Rotator Cuff TearNCT02716441
Rotator Cuff Failure With Continuity
An observational study of Rotator Cuff Tear, run by The Cleveland Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Radio-opaque Tissue Markers
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rotator Cuff Tear
- Being tested
- Radio-opaque Tissue Markers
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio-opaque Tissue MarkersDevice
All participants will undergo implantation of radio-opaque tissue markers on their repaired rotator cuff at the time of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Radio-opaque Tissue Markers | Patients undergoing rotator cuff repair with implantation of radio-opaque tissue markers Receives: Device: Radio-opaque Tissue Markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of surgery and 1, 2 and 5 years following rotator cuff repair
Secondary outcomes (4)
Change in Shoulder Strength
Isometric shoulder strength will be measured using a dynamometer.
Measured: 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
Measured: Day of surgery and 1, 2 and 5 years following rotator cuff repair
Change in Pennsylvania Shoulder Score (PSS)
Patient reported outcome measure
Measured: 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
Measured: 1, 2 and 5 years following rotator cuff repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Derwin, PhD, The Cleveland Clinic
- Investigators
- Kathleen Derwin, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716441
- Sponsor's protocol ID
- 16-089
- Status last verified
- May 2026
- First submitted
- 15 Mar 2016
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Failure With Continuity and Its Relation to Rotator Cuff Repair Clinical Outcomes
- ClinicalTrials.gov ID
- NCT02716441
- Acronym / sponsor ID
- 16-089
- Conditions
- Rotator Cuff Tear
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radio-opaque Tissue Markers | – | Device: Radio-opaque Tissue MarkersPatients undergoing rotator cuff repair with implantation of radio-opaque tissue markers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radio-opaque Tissue MarkersAll participants will undergo implantation of radio-opaque tissue markers on their repaired rotator cuff at the time of surgery. | Device | Radio-opaque Tissue Markers |
Primary outcome
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.
4 secondary outcomes
Change in Shoulder Strength
Time frame: Day of surgery and 1, 2 and 5 years following rotator cuff repair
Change in American Shoulder and Elbow Society (ASES) Score
Time frame: Day of surgery and 1, 2 and 5 years following rotator cuff repair
Change in Pennsylvania Shoulder Score (PSS)
Time frame: Day of surgery, and 1, 2 and 5 years following rotator cuff repair
Tendon Integrity
Time frame: 1, 2 and 5 years following rotator cuff repair
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Derwin, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tendon Retraction (time frame: Day of surgery and 1, 2 and 5 years following rotator cuff repair). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026; AzTrials last refreshed its copy on 28 Oct 2026.