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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02210910 |
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Date of registration:
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06/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.
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Scientific title:
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A Randomized, Two-arm, Prospective Study to Assess the Efficacy and Safety of InSpace™ Device Implanted Over a Rotator Cuff Repair in Comparison With Rotator Cuff Repair Only |
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Date of first enrolment:
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June 2012 |
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Target sample size:
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39 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02210910 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Israel
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Key inclusion & exclusion criteria
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Main Inclusion Criteria:
- Age 40 or older.
- Positive diagnostic MRI of the affected shoulder indicating full thickness large to
massive RCT of at least 3cm in diameter (according to Cofield classification2)
involving one or more tendons. (MRI can be done up to 6 months prior to
randomization.)
- Persistent pain and functional disability of the affected shoulder for at least 3
months.
Main Exclusion Criteria :
- Known allergy to the balloon material (copolymer of PLA and -?-caprolactone).
- 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
Age minimum:
40 Years
Age maximum:
95 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rotator Cuff Tear
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Intervention(s)
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Procedure: Best Repair of torn Rotator Cuff
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Device: InSpace™ system over repair
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Primary Outcome(s)
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The change in the Shoulder Score
[Time Frame: baseline and 6 months]
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Secondary ID(s)
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IS-CL-02-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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