Status:
COMPLETED
Evaluate the Rotator Cuff Repair With "InSpace" VS Without "InSpace"
Lead Sponsor:
Clinique Bizet
Conditions:
Repair of a Cuff Tear
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04704700
Start Date
September 1 2021
End Date
December 31 2025
Last Update
January 5 2026
Active Locations (1)
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1
Clinique Bizet
Paris, France, 75016