InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
NCT ID: NCT02208440
Last Updated: 2020-06-05
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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TERMINATED
NA
14 participants
INTERVENTIONAL
2014-07-31
2019-01-31
Brief Summary
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Detailed Description
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The effectiveness will be assessed by comparing the shoulder outcome scores of each treatment arm ( ASES, Constant and Quick DASH) from pre-operation (baseline) up to 2 years post-operation, with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).
The safety will be asses by comparing the Adverse event rate between the treatment arms.
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 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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Locations
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Wigan and Leigh NHS Foundation Trust: Upper Limb & Trauma Surgery
Wigan, Hall Lane, Appley Bridge, United Kingdom
Countries
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Other Identifiers
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IS-CL-02-UK
Identifier Type: -
Identifier Source: org_study_id
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