Clinical trial NCT05370183: Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room?
Official title: Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Pain
Biceps Tendon Disorder
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: At inclusion (V0)
measure: 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
timeFrame: 3 hours after surgery (V1)
measure: 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
timeFrame: The day after surgery (V2)
measure: 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
timeFrame: 2 weeks after surgery (V3)
measure: 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
timeFrame: 6 weeks after surgery (V4)
measure: 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
timeFrame: 3 months after surgery (V5)
measure: 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
timeFrame: 6 months after surgery (V6)
measure: 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
timeFrame: 12 months after surgery (V7)
Secondary outcomes:
measure: 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
timeFrame: 2 weeks (V3) after surgery
measure: 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
timeFrame: 6 weeks (V4) after surgery
measure: 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
timeFrame: 3 months (V5) after surgery
measure: 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
timeFrame: 6 months (V6) after surgery
measure: 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
timeFrame: 12 months (V7) after surgery
measure: 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 scare's length
timeFrame: 2 weeks (V3) after surgery
measure: 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 scare's length
timeFrame: 6 weeks after surgery
measure: 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 scare's length
timeFrame: 3 months (V5) after surgery
measure: 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 scare's length
timeFrame: 6 months (V6) after surgery
measure: 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 scare's length
timeFrame: 12 months (V7) after surgery
measure: 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 scare's width
timeFrame: 2 weeks (V3) after surgery
measure: 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 scare's width
timeFrame: 6 weeks (V4) after surgery
measure: 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 scare's width
timeFrame: 3 months (V5) after surgery
measure: 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 scare's width
timeFrame: 6 months (V6) after surgery
measure: 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 scare's width
timeFrame: 12 months (V7) after surgery
measure: 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 time to onset
timeFrame: 2 weeks (V3) after surgery
measure: 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 time to onset
timeFrame: 6 weeks (V4) after surgery
measure: 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 time to onset
timeFrame: 3 months (V5) after surgery
measure: 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 time to onset
timeFrame: 6 months (V6) after surgery
measure: 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 time to onset
timeFrame: 12 months (V7) after surgery
measure: 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 possible desunion
timeFrame: 2 weeks (V3) after surgery
measure: 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 possible desunion
timeFrame: 6 weeks (V4) after surgery
measure: 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 possible desunion
timeFrame: 3 months (V5) after surgery
measure: 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 possible desunion
timeFrame: 6 months (V6) after surgery
measure: 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 possible desunion
timeFrame: 12 months (V7) after surgery
measure: 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 shoulder function, in particular on active and passive mobility
timeFrame: At inclusion (V0)
measure: 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 shoulder function, in particular on active and passive mobility
timeFrame: 2 weeks (V3) after surgery
measure: 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 shoulder function, in particular on active and passive mobility
timeFrame: 6 weeks (V4) after surgery
measure: 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 shoulder function, in particular on active and passive mobility
timeFrame: 3 months (V5) after surgery
measure: 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 shoulder function, in particular on active and passive mobility
timeFrame: 6 months (V6) after surgery
measure: 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 shoulder function, in particular on active and passive mobility
timeFrame: 12 months (V7) after surgery
measure: 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 shoulder function, in particular on Subjective Shoulder Value
timeFrame: At inclusion (V0)
measure: 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 shoulder function, in particular on Subjective Shoulder Value
timeFrame: 2 weeks (V3) after surgery
measure: 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 shoulder function, in particular on Subjective Shoulder Value
timeFrame: 6 weeks (V4) after surgery
measure: 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 shoulder function, in particular on Subjective Shoulder Value
timeFrame: 3 months (V5) after surgery
measure: 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 shoulder function, in particular on Subjective Shoulder Value
timeFrame: 6 months (V6) after surgery
measure: 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 shoulder function, in particular on Subjective Shoulder Value
timeFrame: 12 months (V7) after surgery
measure: 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 patient satisfaction, with Constant's score
timeFrame: At inclusion (V0)
measure: 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 patient satisfaction, with Constant's score
timeFrame: 2 weeks (V3) after surgery
measure: 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 patient satisfaction, with Constant's score
timeFrame: 6 weeks (V4) after surgery
measure: 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 patient satisfaction, with Constant's score
timeFrame: 3 months (V5) after surgery
measure: 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 patient satisfaction, with Constant's score
timeFrame: 6 months (V6) after surgery
measure: 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 patient satisfaction, with Constant's score
timeFrame: 12 months (V7) after surgery
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Alpes Maritimes
Study officials:
References: