Shoulder CapsulitisINSTABIONCT04847180
Study of the Antipodal Capsular Fold and Its Potential Role in Antero-inferior Glenohumeral Instability
A study testing Biopsy in people with Shoulder Capsulitis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
In schoulders instabilty, the soft tissue has not been the subject of histological studies, as has the "bare area" or zone devoid of cartilage, the exact role of which in glenohumeral biomechanics is unknown. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Shoulder Capsulitis
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2020to 11 Feb 2024
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Instability Group
- Patient, male or female, over 18 years old and up to 40 years old
- Patient operated for antero-inferior shoulder instability
- Subject affiliated or beneficiary of a social security scheme
- Patient having signed the free and informed consent comparativ group
- Patient, male or female, over 18 years old and up to 40 years old
Show all 9Show fewer
- Patient operated for a reason other than unstable shoulder
- Subject affiliated or beneficiary of a social security scheme
- Patient having signed the free and informed cons
Who cannot join
- History of surgery on the affected shoulder
- Capsuloligamentous disease (Ehler Danlos)
- History of instability (dislocation, subluxation) in witnesses
- Patient participating in another clinical study
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;
- Pregnant, breastfeeding or parturient woman;
- Patient hospitalized without consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Antipodal Capsular Fold and Its Potential Role in Antero-inferior Glenohumeral Instability - Instabio
In schoulders instabilty, the soft tissue has not been the subject of histological studies, as has the "bare area" or zone devoid of cartilage, the exact role of which in glenohumeral biomechanics is unknown. This research is based on the hypothesis that the antipodal lesions are constant, underestimated and that an architectural disorganization at the capsulo-ligament level could contribute to the instability of the shoulder. The aim of this study is therefore to better characterize these lesions which could be the subject of a complementary stabilization procedure even in the absence of a humeral notch
Read the detailed description
Surgery for unstable shoulders sometimes involves repairing lesions that promote instability. These lesions are identified on imaging before surgery and then during the operation, but they are macroscopically inconsistent on genuine unstable shoulders. While the importance of posterior capsuloligamentous structures (soft tissue) in antero-inferior stability has been the subject of biomechanical studies, the soft tissue has not been the subject of histological studies, as has the "bare area" or zone devoid of cartilage, the exact role of which in glenohumeral biomechanics is unknown. However, this research is based on the hypothesis that the antipodal lesions are constant, underestimated and that an architectural disorganization at the capsulo-ligament level could contribute to the instability of the shoulder. The aim of this study is therefore to better characterize these lesions which could be the subject of a complementary stabilization procedure even in the absence of a humeral notch.
- Conditions
- Shoulder Capsulitis
- Being tested
- Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
The biopsy will be performed at the level of the capsular fold located just above the area devoid of cartilage in the postero-superior region of the humeral head, near the area where Hill Sachs notches occur.
| Study group | Role | What they receive |
|---|---|---|
| Instability shoulder group | Experimental | Patients operated for an antero-inferior shoulder instability Receives: Procedure: Biopsy |
| Non instability shoulder group | Other | Patients without shoulder instability, operated for another reason. Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capsule Aspect
Normal capsule versus pathological capsule (abnormal capsule with disorganized framework, fragmented fibers, coiled )
Measured: during biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start26 Aug 2020
- Primary completion12 Jan 2024
- Study completion11 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder CapsulitisStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ramsay santé
- Responsible party
- Sponsor
- Investigators
- Régis GUINAND, Dr, Principal investigator, Clinique de l'Union - Ramsay-santé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847180
- Sponsor's protocol ID
- ID-RCB : 2019-A00859-48
- Acronym
- INSTABIO
- Status last verified
- Jul 2026
- First submitted
- 12 Apr 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Antipodal Capsular Fold and Its Potential Role in Antero-inferior Glenohumeral Instability - Instabio
- ClinicalTrials.gov ID
- NCT04847180
- Acronym / sponsor ID
- INSTABIO / ID-RCB : 2019-A00859-48
- Conditions
- Shoulder Capsulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Ramsay santé
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 11 Feb 2024 (actual)
- First posted
- 19 Apr 2021 (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.
In schoulders instabilty, the soft tissue has not been the subject of histological studies, as has the "bare area" or zone devoid of cartilage, the exact role of which in glenohumeral biomechanics is unknown. This research is based on the hypothesis that the antipodal lesions are constant, underestimated and that an architectural disorganization at the capsulo-ligament level could contribute to the instability of the shoulder. The aim of this study is therefore to better characterize these lesions which could be the subject of a complementary stabilization procedure even in the absence of a humeral notch
Detailed description
Surgery for unstable shoulders sometimes involves repairing lesions that promote instability. These lesions are identified on imaging before surgery and then during the operation, but they are macroscopically inconsistent on genuine unstable shoulders. While the importance of posterior capsuloligamentous structures (soft tissue) in antero-inferior stability has been the subject of biomechanical studies, the soft tissue has not been the subject of histological studies, as has the "bare area" or zone devoid of cartilage, the exact role of which in glenohumeral biomechanics is unknown. However, this research is based on the hypothesis that the antipodal lesions are constant, underestimated and that an architectural disorganization at the capsulo-ligament level could contribute to the instability of the shoulder. The aim of this study is therefore to better characterize these lesions which could be the subject of a complementary stabilization procedure even in the absence of a humeral notch.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instability shoulder group | Experimental | Procedure: BiopsyPatients operated for an antero-inferior shoulder instability |
| Non instability shoulder group | Other | Procedure: BiopsyPatients without shoulder instability, operated for another reason. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Instability Group
- Patient, male or female, over 18 years old and up to 40 years old
- Patient operated for antero-inferior shoulder instability
- Subject affiliated or beneficiary of a social security scheme
- Patient having signed the free and informed consent comparativ group
Key exclusion criteria (7 listed)
- History of surgery on the affected shoulder
- Capsuloligamentous disease (Ehler Danlos)
- History of instability (dislocation, subluxation) in witnesses
- Patient participating in another clinical study
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;
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 |
|---|---|---|
| BiopsyThe biopsy will be performed at the level of the capsular fold located just above the area devoid of cartilage in the postero-superior region of the humeral head, near the area where Hill Sachs notches occur. | Procedure or surgery | Instability shoulder group, Non instability shoulder group |
Primary outcome
Capsule Aspect
Time frame: during biopsy
Normal capsule versus pathological capsule (abnormal capsule with disorganized framework, fragmented fibers, coiled )
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 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Shoulder Capsulitis
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
Active, not recruiting
Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
Idiopathic Adhesive Capsulitis
Not yet recruitingPhase 4
OMT for Adhesive Capsulitis
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
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.
Régis GUINAND, Dr principal investigator
Clinique de l'Union - Ramsay-santé
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Shoulder Capsulitis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 9 inclusion and 7 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 16 Jul 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?
Capsule Aspect (time frame: during biopsy). 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 16 Jul 2026.