At a glance
ClinicalIndex Comparison RecordN/ACompleted· 184 enrolled
Drug / intervention
InSpace sub-acromial tissue spacer system +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Single Blinded, Multi-center, Randomized, Controlled, Pivotal Study to Assess the Safety and Effectiveness of the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
In Brief
A clinical study evaluating InSpace sub-acromial tissue spacer system and Partial repair of rotator cuff for Rotator Cuff Syndrome. Completed, enrolled 184 participants across 21 sites in 2 countries.
Detailed Summary
A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRotator Cuff Syndrome
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedJul 2015
Primary CompletionFeb 2020
Study CompletionMar 2020
TodayJul 2026
First PostedJul 9, 2015
Enrollment StartJun 26, 2015
Primary CompletionFeb 29, 2020
Study CompletionMar 17, 2020
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 11.0 years ago
Interventions
InSpace sub-acromial tissue spacer systemdevice
Arthroscopic implantation of InSpace sub-acromial tissue spacer system
Partial repair of rotator cuffprocedure
Arthroscopic partial repair of rotator cuff