Comparing rotator cuff repair with and without a spacer
Evaluate the Rotator Cuff Repair With "InSpace" VS Without "InSpace"
This study tests if using a special device during rotator cuff surgery can help people heal better and reduce the chances of their shoulder injury coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Clinique Bizet Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04704700 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of using an 'InSpace' device during rotator cuff repair compared to traditional methods without the device. It focuses on measuring the re-rupture rates of the cuff after 12 months in both groups. The study aims to determine if the spacer can improve surgical outcomes for patients with specific types of rotator cuff tears. Participants will be monitored for their recovery and any complications that may arise post-surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals with a repairable supraspinatus and infraspinatus type 2 rupture who have not undergone previous shoulder surgeries.
Not a fit: Patients with conditions such as osteoporosis, major joint trauma, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to lower re-rupture rates and improved recovery for patients undergoing rotator cuff repair.
How similar studies have performed: While the use of spacers in rotator cuff repair is a relatively novel approach, similar studies have shown promising results in improving surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * First intention of the rotator cuff * Repairable supraspinatus and infraspinatus type 2 rupture (according to the PATTE classification, tendon retraction at the top of the humeral head) * No surgical history * Patient who has given his participation agreement to participate in the observational study after information by the surgeon, * Patient living in France and having the capacity to answer alone to the survey. * Subject affiliated to a social security scheme * Lack of participation in another clinical study Exclusion Criteria: * Major subject protected by law, under curatorship or tutorship * Known allergy to Inspace medical device materials (PLA and -θ-caprolactone copolymer) * Osteoporosis * Damaged cartilage * Isolated rupture of the suprascapularis * Glenohumeral instability * Pseudo-paralytic shoulder- Infection * Necrosis * Major joint trauma * Pregnant or breastfeeding women
Where this trial is running
Paris
- Clinique Bizet — Paris, France (Recruiting)
Study contacts
- Principal investigator: philippe VALENTI, DOCTOR — Clinique Bizet
- Study coordinator: bouchra benkessou
- Email: b.benkessou@clinique-bltparis.fr
- Phone: 0033143967823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.