Trials / Terminated
TerminatedNCT02208440
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
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.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 14 (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™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Best Repair of torn Rotator Cuff | |
| DEVICE | InSpace™ system |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2018-07-01
- Completion
- 2019-01-01
- First posted
- 2014-08-05
- Last updated
- 2020-06-05
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02208440. Inclusion in this directory is not an endorsement.