RECURRENCE OF ROTATOR CUFF LESION AFTER SURGICAL REPAIR WITH SINGLE-ROW vs DOUBLE-ROW SUTURE BRID… (NCT06059625) | Clinical Trial Compass
CompletedNot Applicable
RECURRENCE OF ROTATOR CUFF LESION AFTER SURGICAL REPAIR WITH SINGLE-ROW vs DOUBLE-ROW SUTURE BRIDGE TECNIQUE: A COMPARATIVE STUDY
Italy30 participantsStarted 2021-04-14
Plain-language summary
The rotator cuff is a muscle-tendon complex consisting of the tendons of the supraspinatus, subspinatus, subscapularis, and small round muscles capable of allowing movement of the shoulder joint in the various planes of space and stabilizing the glenohumeral joint.
Rotator cuff tendon injuries are very common. In most cases, these injuries are mostly degenerative based, as they are related to the aging process of the individual. However, it is increasingly common to diagnose such injuries in young individuals as well.
The reported incidence of rotator cuff injuries ranges from 5% to 40%, and of course the prevalence increases with age until it reaches 51% in patients older than 80 years.
The diagnosis of rotator cuff injury is made based on clinical examination and instrumental investigations such as Nuclear Magnetic Resonance Imaging (MRI).
Rotator cuff repair involves the use of anchors with included suture threads that allow the tendons to be returned to the level of the anatomical insertion, called the footprint.
Suture technique varies depending on the extent of injury and tendon and bone quality.
Single-row (single row) or double-row suture bridge (double-row suture bridge) anchoring techniques are currently a hotly debated topic in the literature.
Who can participate
Age range
45 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged ≥45 years with a diagnosis of full-thickness rotator cuff injury \<2cm
* Arthroscopic rotator cuff repair surgery with single row or double row suture bridge
* Follow-up \> 24 months
* Completeness of clinical-radiographic documentation
* Patients at first rotator cuff repair surgery on affected side
Exclusion Criteria:
* Patients with associated injuries to the affected upper limb
* Patients with neuromuscular disorders, or established psychomotor disorders
* Patients with associated injuries of the subscapularis muscle tendon
* Patients with a history of previous surgery of the affected shoulder
* Patients with massive rotator cuff injury \> 2cm
* Patients with severe pathologies of other organs or apparatuses that limit competitive or recreational sports activities
* Pregnant women
* Patients who cannot undergo high-field MRI (pcs with cochlear implants, cardiac, vascular or osteoarticular magnetic, pcs with previous gunshot wounds)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
radiological outcome (Sugaya score)
Timeframe: 24 months
2
clinical outcome (American Shoulder and Elbow Surgeons shoulder score)
Timeframe: 24 months
3
clinical outcome (University of California and Los Angeles shoulder score)