InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear
NCT ID: NCT02211183
Last Updated: 2018-04-06
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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TERMINATED
NA
4 participants
INTERVENTIONAL
2014-08-31
2016-02-29
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
TREATMENT
SINGLE
Study Groups
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Best Repair of torn Rotator Cuff
Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.
Best Repair of torn Rotator Cuff
InSpace™ system
Subjects will undergo surgical intervention (usually arthroscopy or mini invasive) of debridement, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system.
InSpace™ system
Interventions
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Best Repair of torn Rotator Cuff
InSpace™ system
Eligibility Criteria
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Inclusion Criteria
* Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT (according to Cofield classification) or long involving more than one tendon.
* Persistent pain and functional disability of the affected shoulder for at least 3 months.
Exclusion Criteria
* Evidence of significant osteoarthritis or cartilage damage in the shoulder
* Evidence of gleno-humeral instability
* Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
* Evidence of major joint trauma, infection, or necrosis in the shoulder
* Partial-thickness tears of the rotator cuff
40 Years
95 Years
ALL
No
Sponsors
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OrthoSpace Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Emilio Calvo, MD
Role: PRINCIPAL_INVESTIGATOR
Head of Shoulder and Elbow Reconstructive Surgery Unit, Department of Orthopedic Surgery and Traumatology
Locations
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Fundacion Jimenez Diaz
Madrid, , Spain
Countries
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Other Identifiers
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IS-CL-02-SP
Identifier Type: -
Identifier Source: org_study_id
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