Evaluate the Rotator Cuff Repair With "InSpace" VS Without "InSpace" (ESPACE)

Clinique Bizet

Status: Completed

Conditions: Repair of a Cuff Tear

Treatments: Device: repair of a cuff tear

Study type: Interventional

Funder types: Other

Identifiers

NCT04704700

2020-A02443-36

Details and patient eligibility

About

Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer

Enrollment: 30 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

patient with inspace device

Active Comparator group

Treatment:

Device: repair of a cuff tear

Device: repair of a cuff tear

patient without inspace device

Placebo Comparator group

Treatment:

Device: repair of a cuff tear

Device: repair of a cuff tear