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Tiny tags track tendon healing after shoulder surgery

NCT ID NCT02716441

Knowledge-focused Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how the repaired rotator cuff tendon moves after surgery, which may affect recovery. 125 people getting rotator cuff repair will have small markers placed on the tendon during surgery. CT scans and MRIs over 5 years will track tendon position and healing, and results will be compared to strength and pain reports.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radio-opaque tissue markers (small tags implanted in the tendon during surgery to track its position over time)
What this could lead to
If successful, this could help doctors better predict which patients will have good or poor recovery after rotator cuff surgery.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. The markers are experimental and may not provide clear answers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2016

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rotator cuff tear

Contacts and locations

Locations

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.