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
1 other identifier
interventional
39
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 6, 2014
CompletedFirst Posted
Study publicly available on registry
August 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedAugust 22, 2018
August 1, 2018
5.8 years
August 6, 2014
August 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in the Shoulder Score
baseline and 6 months
Study Arms (2)
Best Repair of torn Rotator Cuff
SHAM COMPARATORSubjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.
InSpace™ system
ACTIVE COMPARATORSubjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair, and placement of the InSpace™ system.
Interventions
Eligibility Criteria
You may qualify if:
- Age 40 or older.
- Positive diagnostic MRI of the affected shoulder indicating full thickness large to massive RCT of at least 3cm in diameter (according to Cofield classification2) involving one or more tendons. (MRI can be done up to 6 months prior to randomization.)
- Persistent pain and functional disability of the affected shoulder for at least 3 months.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OrthoSpace Ltd.lead
Study Sites (1)
Assuta Medical Center
Tel Aviv, 60710, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2014
First Posted
August 7, 2014
Study Start
June 1, 2012
Primary Completion
March 1, 2018
Study Completion
April 1, 2018
Last Updated
August 22, 2018
Record last verified: 2018-08