Enrollment target has not achieved due to very slow and low recruitment rate
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.
Sponsor study identifier
interventional
14
1 country
1
Study Start
July 2014
Actual (reported)Primary Completion
July 2018
Actual (reported)Study Completion
January 2019
Actual (reported)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 .
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2014
Actual (reported)August 3, 2014
Actual (reported)August 5, 2014
Actual (reported)July 2018
Actual (reported)January 2019
Actual (reported)The change in the Shoulder Score
baseline and 6 months
Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Wigan and Leigh NHS Foundation Trust: Upper Limb & Trauma Surgery
Wigan, Hall Lane, Appley Bridge, WN69EP, United Kingdom
14 participants (actual enrollment reported by the registry).
First Submitted
August 3, 2014
First Posted
August 5, 2014
Study Start
July 2014
Actual (reported)Efficacy of Continuous Infusion Ropivacaine Interscalene Blocks
Contact the study team to confirm eligibility.
Primary Completion
July 2018
Actual (reported)Study Completion
January 2019
Actual (reported)Last Updated
June 5, 2020
Record last verified: 2019-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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