InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
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|ClinicalTrials.gov Identifier: NCT02208440|
Recruitment Status : Terminated (Enrollment target has not achieved due to very slow and low recruitment rate)
First Posted : August 5, 2014
Last Update Posted : June 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Full-thickness Rotator Cuff Tear||Procedure: Best Repair of torn Rotator Cuff Device: InSpace™ system||Not Applicable|
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||The patient is blinded to the treatment type|
|Official Title:||A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Safety and Efficacy of InSpace™ Device in Comparison to Full Thickness Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||January 2019|
Sham Comparator: 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.
Procedure: Best Repair of torn Rotator Cuff
Active Comparator: 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.
Device: InSpace™ system
- The change in the Shoulder Score [ Time Frame: baseline and 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208440
|Wigan and Leigh NHS Foundation Trust: Upper Limb & Trauma Surgery|
|Wigan, Hall Lane, Appley Bridge, United Kingdom, WN69EP|