Evaluate the Rotator Cuff Repair With "InSpace" VS Without "InSpace"
NCT ID: NCT04704700
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-09-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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patient with inspace device
repair of a cuff tear
Group (Treatment): Arthroscopic Implantation of the System InSpace on a repaired rotator cuff tendon
patient without inspace device
repair of a cuff tear
Group (Control): standard Arthroscopic repair of the cuff rotator
Interventions
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repair of a cuff tear
Group (Treatment): Arthroscopic Implantation of the System InSpace on a repaired rotator cuff tendon
repair of a cuff tear
Group (Control): standard Arthroscopic repair of the cuff rotator
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
75 Years
ALL
No
Sponsors
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Clinique Bizet
OTHER
Responsible Party
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Principal Investigators
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philippe VALENTI, DOCTOR
Role: PRINCIPAL_INVESTIGATOR
Clinique Bizet
Locations
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Clinique Bizet
Paris, , France
Countries
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Other Identifiers
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2020-A02443-36
Identifier Type: -
Identifier Source: org_study_id
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