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NCT05370183 | Recruiting | Shoulder Pain


Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room?
Sponsor:

Nice University Hospital Center

Brief Summary:

Mini-optics has been used in orthopedics for a short time. The Nanoscope used in this study is marketed by Arthrex. Its main indications concern knee, elbow, wrist, carp and small joints of long fingers for diagnostic and sometimes therapeutic purposes. Some teams use it to replace expensive radiological examinations and/or difficult to access, in consultation, for diagnostic in the knee, but also for therapeutic for partial meniscectomy with several related publications. The investigators recently published a feasibility study of isolated tenotomy of the biceps with this minimally invasive device in consultation (first indexed article describing this technique). This project is part of the broader context of "In Office" surgery, for which there are many applications. Through the miniaturisation of optics and access to "portable" technologies, surgical procedures can now be performed in consultation ("In Office"). For example: release of the carpal tunnel or ulnar canal to the elbow under ultrasound, partial meniscectomy, removal of foreign body from the elbow in consultation. Indeed, in addition to the technical interest of this innovation for a simple and frequent surgical procedure, it should make it possible to transpose anxiety management for the patient, time-consuming and costly for the institution into a heavy technical platform (operating room) towards a simplified, fast and streamlined approach in consultation. In the scientific literature, other equivalent surgical procedures have already been identified and performed in consultation with various tools (carpal tunnel, ulnar nerve in the elbow, meniscectomy in the knee but also in other surgical specialties such as cataract in ophthalmology) with better patient satisfaction, improved patient journey, reduced costs, an increase in the number of patients treated. The investigators wish to demonstrate the non-inferiority of intraarticular tenotomy of the biceps long head performed in consultation with mini-optics and local anaesthesia compared to the operating room in order to modify practices and optimize the management of patients within the institution while improving their satisfaction.

Condition or disease

Shoulder Pain

Biceps Tendon Disorder

Intervention/treatment

Hyperambulatory tenotomy

Operating room tenotomy

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 40 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room?
Actual Study Start Date : November 29, 2022
Estimated Primary Completion Date : May 29, 2025
Estimated Study Completion Date : May 29, 2025
Arm Intervention/treatment

Experimental: Hyperambulatory tenotomy

regarding randomization result, patient will have a tenotomy of biceps' long head by mini-optics in consultation

Procedure: Hyperambulatory tenotomy

Active Comparator: Operating room tenotomy

regarding randomization result, patient will have a tenotomy of biceps' long head upon arthroscopy under normal operating condition

Procedure: Operating room tenotomy

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room?

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Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room?

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Locations


Recruiting

France, Alpes Maritimes

chu's nice

Nice, Alpes Maritimes, France, 06000

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