Shoulder surgery without the OR? new study tests In-Office biceps tenotomy
NCT ID NCT05370183
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times
Summary
This study tests if a biceps tendon cutting procedure (tenotomy) done in the doctor's office with a tiny camera and local anesthesia works as well as the same surgery in an operating room. 14 adults with shoulder pain from biceps or rotator cuff problems will be enrolled. The main goal is to see if pain relief is similar between the two approaches.
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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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14 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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May 2025
- 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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18 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * patient over 18 years-old, * With shoulder pain associated to massive irreparable rotator cuff and a biceps still presents (premature Hamada's stages, 1 to 3); Or with an isolated pathology of biceps with intact rotator cuff (in particular bicipital instability, subluxation, tenosynovitis, pre-rupture) * Indication for tenotomy according orthopedic surgeon * having given written consent after written and oral information, * member of the social security system. Exclusion Criteria: * patient protected by law or under guardianship r curatorship, or not able to participae in a clinical trial under L.1121-16 article of French Public Health Regulations * pregnant or nursing patient, * Allergies to local anesthetics * Athletes * Capsulitis in progress * history of shoulder surgery * Medical history of infection * fracture of proximal end of the humerus * Patient refusal to take part
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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.
Contacts and locations
Locations
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CHU de Nice
Nice, Alpes Maritimes, 06000, France
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Other studies related to the condition(s) this trial covers.
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