Back to resultsInSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.
Primary Purpose
Rotator Cuff Tear
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
InSpace™ system over repair
Best Repair of torn Rotator Cuff
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Massive Rotator Cuff Tear, Sub-acromial spacer, Best repair of rotator cuff
Eligibility Criteria
Main Inclusion Criteria:
- 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.
Main 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
Sites / Locations
- Assuta Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Best Repair of torn Rotator Cuff
InSpace™ system
Arm Description
Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.
Subjects 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.
Outcomes
Primary Outcome Measures
The change in the Shoulder Score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02210910
Brief Title
InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrthoSpace Ltd.
4. Oversight
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
Massive Rotator Cuff Tear, Sub-acromial spacer, Best repair of rotator cuff
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Best Repair of torn Rotator Cuff
Arm Type
Sham Comparator
Arm Description
Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.
Arm Title
InSpace™ system
Arm Type
Active Comparator
Arm Description
Subjects 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.
Intervention Type
Device
Intervention Name(s)
InSpace™ system over repair
Intervention Type
Procedure
Intervention Name(s)
Best Repair of torn Rotator Cuff
Primary Outcome Measure Information:
Title
The change in the Shoulder Score
Time Frame
baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
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.
Main 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
Facility Information:
Facility Name
Assuta Medical Center
City
Tel Aviv
ZIP/Postal Code
60710
Country
Israel
12. IPD Sharing Statement
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InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.
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