Trials / Completed
CompletedNCT02210910
InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- OrthoSpace Ltd. · Industry
- Sex
- All
- Age
- 40 Years – 95 Years
- Healthy volunteers
- Not accepted
Summary
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ in the study population in comparison to surgical RCT repair.
Detailed description
The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | InSpace™ system over repair | |
| PROCEDURE | Best Repair of torn Rotator Cuff |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2018-03-01
- Completion
- 2018-04-01
- First posted
- 2014-08-07
- Last updated
- 2018-08-22
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT02210910. Inclusion in this directory is not an endorsement.