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

NCT05370183 | Active Not Recruiting DMC

• 1 other identifier: 21-AOI-13
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain; Biceps Tendon Disorder

Outcome Measures

Primary Outcomes (8)

• Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient

  Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.

  At inclusion (V0)

• Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient

  Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.

  3 hours after surgery (V1)

• Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient

  Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.

  The day after surgery (V2)

• Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient

  Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.

  2 weeks after surgery (V3)

• Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient

  Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.

  6 weeks after surgery (V4)

• Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient

  Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.

  3 months after surgery (V5)

• Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient

  Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.

  6 months after surgery (V6)

• Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient

  Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.

  12 months after surgery (V7)

Secondary Outcomes (43)

• Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare

  2 weeks (V3) after surgery

• Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare

  6 weeks (V4) after surgery

• Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare

  3 months (V5) after surgery

• Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare

  6 months (V6) after surgery

• Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare

  12 months (V7) after surgery

Study Arms (2)

Hyperambulatory tenotomy

EXPERIMENTAL

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

Procedure: Hyperambulatory tenotomy

Operating room tenotomy

ACTIVE COMPARATOR

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

Procedure: Operating room tenotomy

Interventions

Hyperambulatory tenotomy PROCEDURE

Using mini-optics a minimally invasive device, hypermabulatory tenotomy is performed in consultation, with a local anethesia

Hyperambulatory tenotomy

Operating room tenotomy PROCEDURE

Operating room tenotomy is performed according standard practice, with general anesthesia.

Operating room tenotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Alpes Maritimes, 06000, France

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 11, 2022
• Study Start: November 29, 2022
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)