Trials / Completed
CompletedNCT02493660
A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 184 (actual)
- Sponsor
- OrthoSpace Ltd. · Industry
- Sex
- All
- Age
- 40 Years – 100 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This is a non-inferiority, prospective, single blinded, multi-center, randomized, controlled, pivotal study evaluating the safety and effectiveness of the InSpace™ device as a primary surgical treatment for full thickness MRCT in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | InSpace sub-acromial tissue spacer system | Arthroscopic implantation of InSpace sub-acromial tissue spacer system |
| PROCEDURE | Partial repair of rotator cuff | Arthroscopic partial repair of rotator cuff |
Timeline
- Start date
- 2015-06-26
- Primary completion
- 2020-02-29
- Completion
- 2020-03-17
- First posted
- 2015-07-09
- Last updated
- 2022-06-15
- Results posted
- 2021-07-22
Locations
21 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02493660. Inclusion in this directory is not an endorsement.