Shoulder PainNANOBICEPSNCT05370183
Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room?
A study testing Hyperambulatory tenotomy and Operating room tenotomy in people with Shoulder Pain and Biceps Tendon Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain, Biceps Tendon Disorder
- What is being tested?
- Hyperambulatory tenotomy and Operating room tenotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2022to 5 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Medical history of infection
- fracture of proximal end of the humerus
- Patient refusal to take part
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Hyperambulatory tenotomy, Operating room tenotomy
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperambulatory tenotomyProcedure or surgery
Using mini-optics a minimally invasive device, hypermabulatory tenotomy is performed in consultation, with a local anethesia
Operating room tenotomyProcedure or surgery
Operating room tenotomy is performed according standard practice, with general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Hyperambulatory tenotomy | Experimental | regarding randomization result, patient wil have a tenotomy of biceps' long head by mini-optics in consultation Receives: 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 Receives: Procedure: Operating room tenotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Number of scare will be visually evaluated by investigators
Measured: 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
Number of scare will be visually evaluated by investigators
Measured: 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
Number of scare will be visually evaluated by investigators
Measured: 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
Number of scare will be visually evaluated by investigators
Measured: 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
Number of scare will be visually evaluated by investigators
Measured: 12 months (V7) 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 scare's length
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Measured: 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 scare's length
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Measured: 6 weeks 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 scare's length
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Measured: 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 scare's length
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Measured: 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 scare's length
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Measured: 12 months (V7) 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 scare's width
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Measured: 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 scare's width
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Measured: 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 scare's width
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Measured: 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 scare's width
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Measured: 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 scare's width
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Measured: 12 months (V7) 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 time to onset
Time to onset will be evaluated by investigator, in number of days.
Measured: 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 time to onset
Time to onset will be evaluated by investigator, in number of days.
Measured: 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 time to onset
Time to onset will be evaluated by investigator, in number of days.
Measured: 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 time to onset
Time to onset will be evaluated by investigator, in number of days.
Measured: 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 time to onset
Time to onset will be evaluated by investigator, in number of days.
Measured: 12 months (V7) 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 possible desunion
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Measured: 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 possible desunion
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Measured: 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 possible desunion
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Measured: 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 possible desunion
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Measured: 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 possible desunion
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Measured: 12 months (V7) 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 12 months (V7) 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 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)
Measured: 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 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)
Measured: 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 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)
Measured: 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 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)
Measured: 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 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)
Measured: 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 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)
Measured: 12 months (V7) 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 patient satisfaction, with Constant's score
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Measured: 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 patient satisfaction, with Constant's score
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Measured: 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 patient satisfaction, with Constant's score
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Measured: 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 patient satisfaction, with Constant's score
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Measured: 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 patient satisfaction, with Constant's score
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Measured: 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 patient satisfaction, with Constant's score
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Measured: 12 months (V7) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start29 Nov 2022
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370183
- Sponsor's protocol ID
- 21-AOI-13
- Acronym
- NANOBICEPS
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2022
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room?
- ClinicalTrials.gov ID
- NCT05370183
- Acronym / sponsor ID
- NANOBICEPS / 21-AOI-13
- Conditions
- Shoulder Pain, Biceps Tendon Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperambulatory tenotomy | Experimental | Procedure: Hyperambulatory tenotomyregarding randomization result, patient wil have a tenotomy of biceps' long head by mini-optics in consultation |
| Operating room tenotomy | Active comparator | Procedure: Operating room tenotomyregarding randomization result, patient wil have a tenotomy of biceps' long head upon arthroscopy under normal operating condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperambulatory tenotomyUsing mini-optics a minimally invasive device, hypermabulatory tenotomy is performed in consultation, with a local anethesia | Procedure or surgery | Hyperambulatory tenotomy |
| Operating room tenotomyOperating room tenotomy is performed according standard practice, with general anesthesia. | Procedure or surgery | Operating room tenotomy |
Primary outcome
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
Time frame: At inclusion (V0)
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.
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
Time frame: 3 hours after surgery (V1)
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.
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
Time frame: The day after surgery (V2)
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.
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
Time frame: 2 weeks after surgery (V3)
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.
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
Time frame: 6 weeks after surgery (V4)
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.
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
Time frame: 3 months after surgery (V5)
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.
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
Time frame: 6 months after surgery (V6)
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.
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
Time frame: 12 months after surgery (V7)
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.
43 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months (V7) 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 scare's length
Time frame: 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 scare's length
Time frame: 6 weeks 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 scare's length
Time frame: 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 scare's length
Time frame: 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 scare's length
Time frame: 12 months (V7) 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 scare's width
Time frame: 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 scare's width
Time frame: 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 scare's width
Time frame: 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 scare's width
Time frame: 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 scare's width
Time frame: 12 months (V7) 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 time to onset
Time frame: 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 time to onset
Time frame: 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 time to onset
Time frame: 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 time to onset
Time frame: 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 time to onset
Time frame: 12 months (V7) 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 possible desunion
Time frame: 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 possible desunion
Time frame: 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 possible desunion
Time frame: 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 possible desunion
Time frame: 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 possible desunion
Time frame: 12 months (V7) 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 shoulder function, in particular on active and passive mobility
Time frame: 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 shoulder function, in particular on active and passive mobility
Time frame: 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 shoulder function, in particular on active and passive mobility
Time frame: 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 shoulder function, in particular on active and passive mobility
Time frame: 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 shoulder function, in particular on active and passive mobility
Time frame: 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 shoulder function, in particular on active and passive mobility
Time frame: 12 months (V7) 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 shoulder function, in particular on Subjective Shoulder Value
Time frame: 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 shoulder function, in particular on Subjective Shoulder Value
Time frame: 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 shoulder function, in particular on Subjective Shoulder Value
Time frame: 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 shoulder function, in particular on Subjective Shoulder Value
Time frame: 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 shoulder function, in particular on Subjective Shoulder Value
Time frame: 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 shoulder function, in particular on Subjective Shoulder Value
Time frame: 12 months (V7) 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 patient satisfaction, with Constant's score
Time frame: 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 patient satisfaction, with Constant's score
Time frame: 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 patient satisfaction, with Constant's score
Time frame: 6 weeks (V4) after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperambulatory tenotomy and Operating room tenotomy in people with Shoulder Pain and Biceps Tendon Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: At inclusion (V0)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.