Recurrent Anterior Shoulder InstabilityISIS-2017NCT03654118
Long-term Review of a Cohort of Arthroscopic Bankart Interventions
An observational study of Recurrent Anterior Shoulder Instability, run by Rennes University Hospital at 11 sites in France.
Trial summary
Recurrent instability is the most common chronic shoulder pathology of the young and athletic patient. It is a source of functional, sporting and professional disability, and a permanent apprehension to the use of the affected shoulder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Anterior Shoulder Instability
- What is being tested?
- Phone follow-up
- How many people
- 125 participants
- Where
- 11 sitesFrance
- Study dates
- 7 Aug 2017to 9 Nov 2017
- Phase
- Observational
- 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
Study population: Patients operated between December 2007 and December 2008 for recurrent shoulder instability, according to the arthroscopic procedure (Arthroscopic Bankart)
Who may be able to join
- Major patient
- Patient who already volunteered in a first ISIS study
- Patients operated between December 2007 and December 2008 for recurrent shoulder instability, according to the arthroscopic procedure (Arthroscopic Bankart) in the investigative centers and presenting at the time of the indication of operation an ISIS score of ≤ 4 points (regardless of the positive criteria) (see Annex 2- ISIS score)
- Age> 16 years
- Supported by a joint arthroscopic technique completed.
- Patient not objecting to his participation in the study
Who cannot join
- First dislocation or resumption of another technique at the time of indication for surgery
- Voluntary or multidirectional instability at the time of the indication of operation
- Painful shoulder without instability felt at the time of the operative indication
- Lesion of the cap (perioperative report)
- Humeral lesions Avulsion Gleno-humeral Ligament (per-operative finding)
- Unsuccessful technique
- Major benefiting from a legal protection measure (safeguard of justice, trusteeship, guardianship)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Clinique parc Rambot Provençale
Aix-en-Provence, 13100
Clinique Générale d'Annecy
Annecy, 74000
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
Clinique du Cambresis
Cambrai, 59400
Clinique des Cèdres
Échirolles, 38432
Clinique François 1er
Le Havre, 76600
Clinique du Sport de Bordeaux-Mérignac
Mérignac, 33700
Hôpital Archet II
Nice, 06202
Hôpital Saint-Antoine / APHP
Paris, 75000
Clinique Turin
Paris, 75008
Centre Hospitalier Universitaire de RENNES
Rennes
About this study
Recurrent instability is the most common chronic shoulder pathology of the young and athletic patient. It is a source of functional, sporting and professional disability, and a permanent apprehension to the use of the affected shoulder.
Surgical treatment has been proposed for a long time by the reintegration of the labrum (intervention of Bankart) then by the making of an osteo-muscular stop (intervention of Latarjet).
Read more
Like in many domains, surgical techniques have evaluated towards the search for endoscopic alternatives to open surgery, more deleterious.
Bankart's intervention has been performed arthroscopically since the 1980s and remains the majority intervention in the United States. However, its success rate never reached that of open techniques, Bankart and Latarjet. Surgeons therefore sought the predictors of these failures in order to define the limits of the indications for arthroscopic Bankart intervention.
The determination and use of the preoperative instability score (Instability Severity Index Score : ISIS) described by Balg and Boileau is one of the ways to clarify these indications.
The aim of this study is to prospectively establish the values of the ISIS score to obtain an acceptable recurrence rate of long-term instability
- Conditions
- Recurrent Anterior Shoulder Instability
- Being tested
- Phone follow-up
- Keywords
- Arthroscopy, Bankart, Shoulder, ISIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone follow-upOther
Through a short phone interview :
- Determination of a complication (Infection, capsulitis, recurrence)
- Determination of the Rowe score
- Determination of the Walch-Duplay score
| Study group | Role | What they receive |
|---|---|---|
| ISIS cohort | Patients operated between December 2007 and December 2008 for recurrent shoulder instability using the arthroscopic procedure (Arthroscopic Bankart) in the investigative centers and presenting at the time of indication for surgery an ISIS score ≤ 4 points
Phone follow-up Receives: Other: Phone follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of instability recurrence after arthroscopic Bankart intervention
The rate of instability recurrence 9 years after an arthroscopic Bankart intervention, is derived from the patient's responses to the interview
Measured: Through study completion, 2 months on average
Secondary outcomes (1)
Predictive value of the ISIS score in the occurrence of recurrence of instability
Measured: Through study completion, 2 months on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start7 Aug 2017
- Primary completion9 Nov 2017
- Study completion9 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Anterior Shoulder InstabilityStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé THOMAZEAU, MD, PhD, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654118
- Sponsor's protocol ID
- 35RC17_3025
- Other IDs
- 2017-A01665-48
- Acronym
- ISIS-2017
- Status last verified
- Aug 2018
- First submitted
- 28 Aug 2018
- Last updated
- 31 Aug 2018
- 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 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Review of a Cohort of Arthroscopic Bankart Interventions
- ClinicalTrials.gov ID
- NCT03654118
- Acronym / sponsor ID
- ISIS-2017 / 35RC17_3025
- Conditions
- Recurrent Anterior Shoulder Instability
- Keywords
- Arthroscopy, Bankart, Shoulder, ISIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 9 Nov 2017 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 31 Aug 2018 (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.
Recurrent instability is the most common chronic shoulder pathology of the young and athletic patient. It is a source of functional, sporting and professional disability, and a permanent apprehension to the use of the affected shoulder.
Surgical treatment has been proposed for a long time by the reintegration of the labrum (intervention of Bankart) then by the making of an osteo-muscular stop (intervention of Latarjet).
Like in many domains, surgical techniques have evaluated towards the search for endoscopic alternatives to open surgery, more deleterious.
Bankart's intervention has been performed arthroscopically since the 1980s and remains the majority intervention in the United States. However, its success rate never reached that of open techniques, Bankart and Latarjet. Surgeons therefore sought the predictors of these failures in order to define the limits of the indications for arthroscopic Bankart intervention.
The determination and use of the preoperative instability score (Instability Severity Index Score : ISIS) described by Balg and Boileau is one of the ways to clarify these indications.
The aim of this study is to prospectively establish the values of the ISIS score to obtain an acceptable recurrence rate of long-term instability
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ISIS cohort | – | Other: Phone follow-upPatients operated between December 2007 and December 2008 for recurrent shoulder instability using the arthroscopic procedure (Arthroscopic Bankart) in the investigative centers and presenting at the time of indication for surgery an ISIS score ≤ 4 points Phone follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated between December 2007 and December 2008 for recurrent shoulder instability, according to the arthroscopic procedure (Arthroscopic Bankart)
Key inclusion criteria (6 listed)
- Major patient
- Patient who already volunteered in a first ISIS study
- Patients operated between December 2007 and December 2008 for recurrent shoulder instability, according to the arthroscopic procedure (Arthroscopic Bankart) in the investigative centers and presenting at the time of the indication of operation an ISIS score of ≤ 4 points (regardless of the positive criteria) (see Annex 2- ISIS score)
- Age> 16 years
- Supported by a joint arthroscopic technique completed.
Key exclusion criteria (7 listed)
- First dislocation or resumption of another technique at the time of indication for surgery
- Voluntary or multidirectional instability at the time of the indication of operation
- Painful shoulder without instability felt at the time of the operative indication
- Lesion of the cap (perioperative report)
- Humeral lesions Avulsion Gleno-humeral Ligament (per-operative finding)
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 |
|---|---|---|
| Phone follow-upThrough a short phone interview : * Determination of a complication (Infection, capsulitis, recurrence) * Determination of the Rowe score * Determination of the Walch-Duplay score | Other | ISIS cohort |
Primary outcome
Number of instability recurrence after arthroscopic Bankart intervention
Time frame: Through study completion, 2 months on average
The rate of instability recurrence 9 years after an arthroscopic Bankart intervention, is derived from the patient's responses to the interview
1 secondary outcome
Predictive value of the ISIS score in the occurrence of recurrence of instability
Time frame: Through study completion, 2 months on average
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 31 Aug 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Recurrent Anterior Shoulder Instability
Recruiting
Surgical Stabilization of Anterior Shoulder Instability Using the Open Latarjet Procedure, With or Without Anterior Capsuloplasty Using the Coracoacromial Ligament.
Recurrent Anterior Shoulder Instability
Active, not recruiting
Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability
Shoulder Dislocation
Recruiting
Surgical Treatment of Recurrent Shoulder Dislocations
Shoulder Instability
Recruiting
Labroplasty in Cases of Anterior Shoulder Instability With Subcritical Glenoid Bone Loss
Recurrent Anterior Shoulder Instability
Not yet recruitingObservational study
Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes (SALTO)
Anterior Shoulder Dislocation, Shoulder Dislocation Closed Traumatic
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.
Hervé THOMAZEAU, MD, PhD study director
Rennes University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Anterior Shoulder Instability, run by Rennes University Hospital at 11 sites 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 6 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Number of instability recurrence after arthroscopic Bankart intervention (time frame: Through study completion, 2 months on average). 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 31 Aug 2018.