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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- The change in the Shoulder Score
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The patient is blinded to the treatment type
Eligibility Criteria
- Ages
- 40 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Main Inclusion Criteria:
- •Age 40 or older.
- •Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT involving more than one tendon.
- •Persistent pain and functional disability of the affected shoulder for at least 3 months.
Exclusion Criteria
- •Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
- •Evidence of significant osteoarthritis or cartilage damage in the shoulder
- •Evidence of gleno-humeral instability
- •Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
- •Evidence of major joint trauma, infection, or necrosis in the shoulder
- •Partial-thickness tears of the rotator cuff
Outcomes
Primary Outcomes
The change in the Shoulder Score
Time Frame: baseline and 6 months
Secondary Outcomes
No secondary outcomes reported