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New Self-Locking biceps repair could reduce popeye deformity after rotator cuff surgery
NCT ID NCT06774820
First seen Jul 07, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This trial compares a new self-locking biceps tenodesis technique against a standard method for repairing the biceps tendon during rotator cuff surgery. About 100 adults with full-thickness rotator cuff tears and biceps tendon issues will be randomly assigned to one of the two procedures. The goal is to see which technique leads to better shoulder function and fewer complications, such as the Popeye deformity where the biceps muscle bulges abnormally.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- self-locking biceps tenodesis (surgical procedure)
- What this could lead to
- If successful, this new self-locking technique could become the preferred method for biceps tendon repair, reducing the risk of Popeye deformity and improving shoulder function.
- What could go wrong
- This is a small, early-stage trial comparing two surgical techniques. The new method may not prove superior, and individual results vary. Surgery carries standard risks like infection or stiffness.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Rotator cuff tear: confirmed preoperative diagnosis of a non- traumatic, full- thickness tear of the supraspinatus and/or infraspinatus and/or subscapularis tendon, as evidenced by ultrasound, arthro- CT or MRI. * Language proficiency: sufficient to allow for communication during the informed consent process and for the completion of the study questionnaires. Exclusion Criteria: * Tear type: partial thickness rotator cuff tears are excluded. * Tear severity: individuals with massive or irreparable rotator cuff tears are excluded. * Fatty degeneration: presence of rotator cuff muscle fatty degeneration classified as Grade 4 according to the Goutallier system will result in exclusion. * Glenohumeral osteoarthritis: patients exhibiting glenohumeral osteoarthritis, defined radiographically by the presence of joint space narrowing or osteophytes on anteroposterior (radiographs of the affected shoulder) will be excluded. * Prior shoulder surgery: history of previous surgical intervention on the affected shoulder will result in exclusion. * Popeye sign: preoperative presence of the Popeye sign will result in exclusion. * Cognitive impairment: pre- existing dementia or any condition that impairs the ability to understand study procedures and complete questionnaires and assessments is an exclusion criterion. * Pregnant, parturient or breast-feeding patients. * Persons under legal protection (curatorship, guardianship, safeguard of justice). * Persons deprived of their liberty by judicial or administrative measure * Persons under psychiatric care * Persons not affiliated to a social security scheme
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Clinique Générale
RECRUITINGAnnecy, 74000, France
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