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

Shoulder Pain Clinical Trial

— NANOBICEPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05370183
• Other study ID #: 21-AOI-13
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2022
• Est. completion date: May 29, 2025

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Marc-Olivier GAUCI
• Phone: 04 92 03 69 04
• Email: gauci.mo[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 29, 2025
• Est. primary completion date: May 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biceps Tendon Disorder
• Shoulder Pain
• Tendinopathy

Intervention

Procedure:
• Hyperambulatory tenotomy
Using mini-optics a minimally invasive device, hypermabulatory tenotomy is performed in consultation, with a local anethesia
• Operating room tenotomy
Operating room tenotomy is performed according standard practice, with general anesthesia.

Locations

Country	Name	City	State
France	CHU de Nice	Nice	Alpes Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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	Number of scare will be visually evaluated by investigators	2 weeks (V3) after surgery
Secondary	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	Number of scare will be visually evaluated by investigators	6 weeks (V4) after surgery
Secondary	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	Number of scare will be visually evaluated by investigators	3 months (V5) after surgery
Secondary	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	Number of scare will be visually evaluated by investigators	6 months (V6) after surgery
Secondary	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	Number of scare will be visually evaluated by investigators	12 months (V7) after surgery
Secondary	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	Scare's length will be assessed by investigator with a small ruler, in millimeter.	2 weeks (V3) after surgery
Secondary	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	Scare's length will be assessed by investigator with a small ruler, in millimeter.	6 weeks after surgery
Secondary	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	Scare's length will be assessed by investigator with a small ruler, in millimeter.	3 months (V5) after surgery
Secondary	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	Scare's length will be assessed by investigator with a small ruler, in millimeter.	6 months (V6) after surgery
Secondary	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	Scare's length will be assessed by investigator with a small ruler, in millimeter.	12 months (V7) after surgery
Secondary	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	Scare's width will be assessed by investigator with a small ruler, in millimeter.	2 weeks (V3) after surgery
Secondary	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	Scare's width will be assessed by investigator with a small ruler, in millimeter.	6 weeks (V4) after surgery
Secondary	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	Scare's width will be assessed by investigator with a small ruler, in millimeter.	3 months (V5) after surgery
Secondary	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	Scare's width will be assessed by investigator with a small ruler, in millimeter.	6 months (V6) after surgery
Secondary	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	Scare's width will be assessed by investigator with a small ruler, in millimeter.	12 months (V7) after surgery
Secondary	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	Time to onset will be evaluated by investigator, in number of days.	2 weeks (V3) after surgery
Secondary	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	Time to onset will be evaluated by investigator, in number of days.	6 weeks (V4) after surgery
Secondary	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	Time to onset will be evaluated by investigator, in number of days.	3 months (V5) after surgery
Secondary	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	Time to onset will be evaluated by investigator, in number of days.	6 months (V6) after surgery
Secondary	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	Time to onset will be evaluated by investigator, in number of days.	12 months (V7) after surgery
Secondary	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	Desunion will be evaluated by investigator, with 2 possible values : yes or no.	2 weeks (V3) after surgery
Secondary	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	Desunion will be evaluated by investigator, with 2 possible values : yes or no.	6 weeks (V4) after surgery
Secondary	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	Desunion will be evaluated by investigator, with 2 possible values : yes or no.	3 months (V5) after surgery
Secondary	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	Desunion will be evaluated by investigator, with 2 possible values : yes or no.	6 months (V6) after surgery
Secondary	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	Desunion will be evaluated by investigator, with 2 possible values : yes or no.	12 months (V7) after surgery
Secondary	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	Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.	At inclusion (V0)
Secondary	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	Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.	2 weeks (V3) after surgery
Secondary	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	Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.	6 weeks (V4) after surgery
Secondary	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	Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.	3 months (V5) after surgery
Secondary	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	Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.	6 months (V6) after surgery
Secondary	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	Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.	12 months (V7) after surgery
Secondary	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	The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)	At inclusion (V0)
Secondary	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	The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)	2 weeks (V3) after surgery
Secondary	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	The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)	6 weeks (V4) after surgery
Secondary	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	The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)	3 months (V5) after surgery
Secondary	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	The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)	6 months (V6) after surgery
Secondary	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	The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)	12 months (V7) after surgery
Secondary	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	Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.	At inclusion (V0)
Secondary	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	Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.	2 weeks (V3) after surgery
Secondary	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	Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.	6 weeks (V4) after surgery
Secondary	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	Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.	3 months (V5) after surgery
Secondary	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	Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.	6 months (V6) after surgery
Secondary	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	Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.	12 months (V7) after surgery