Repair of a Cuff Tear
Conditions
Brief summary
Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer
Interventions
DEVICErepair of a cuff tear
Group (Treatment): Arthroscopic Implantation of the System InSpace on a repaired rotator cuff tendon
Sponsors
Clinique Bizet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the re-rupture rate | 12 months | with radiological imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate mobility | up to 12 months | the Constant score |
| Assess shoulder pain | up to 12 months | VISUAL ANALOGIC SCALE |
| the quality of life assessed | up to 12 months | Simple Shoulder Test, Subjective Shoulder Value and American Shoulder and Elbow Surgeons Shoulder Score |
| resumption of work | up to 12 months | Physicians Global Assessment for resumption of work |
Countries
France
Outcome results
None listed