Back to resultsInSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear
Primary Purpose
Rotator Cuff Tear
Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Best Repair of torn Rotator Cuff
InSpace™ system
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 imaging of the affected shoulder indicating full thickness Massive RCT (according to Cofield classification) or long involving more than one tendon.
- 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
- Fundacion Jimenez Diaz
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 or mini invasive) of debridement, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system.
Outcomes
Primary Outcome Measures
The change in Shoulder Score from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02211183
Brief Title
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Very Low recruitment rate
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrthoSpace Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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
4 (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 or mini invasive) of debridement, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system.
Intervention Type
Procedure
Intervention Name(s)
Best Repair of torn Rotator Cuff
Intervention Type
Device
Intervention Name(s)
InSpace™ system
Primary Outcome Measure Information:
Title
The change in Shoulder Score from baseline
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 imaging of the affected shoulder indicating full thickness Massive RCT (according to Cofield classification) or long involving more than one tendon.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilio Calvo, MD
Organizational Affiliation
Head of Shoulder and Elbow Reconstructive Surgery Unit, Department of Orthopedic Surgery and Traumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear
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