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

Save

Report Abuse

Description

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.

Study Overview

Start Date
November 29, 2022
Completion Date
May 29, 2025
Enrollment
40
Date Posted
May 11, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
CHU de Nice
Nice, Alpes Maritimes 06000, France

Eligibility

Minimum Age (years)
18
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

Study Contact Info

Study Contact Name
Marc-Olivier GAUCI
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

Tenotomy of Biceps’ Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room? 0 reviews

Write Your Review

There are no reviews yet.

Write Your Review

Your email address will not be published. Required fields are marked *

Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05370183