Back to resultsInSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
Primary Purpose
Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV
Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Best Repair of torn Rotator Cuff
InSpace™ system
Sponsored by
About this trial
This is an interventional treatment trial for Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV 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 (CT arthrogram or MRI)* of the affected shoulder indicating full thickness Massive RCT of at least 5cm in diameter (according to Cofield classification) or long - narrow tears of at least 4cm2 (W>2cm and L>2cm) including fatty infiltration grade III or IV (according to classification of Goutallier) 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
- Policlinico
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 debridment, 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 debridment, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system.
Outcomes
Primary Outcome Measures
Comparison of respose rate at each treatment arm
The primary efficacy outcome of the study is considered as the subject response/rehabilitation rate at 6 month post implantation as assesed by the change in the Shoulder Score
Secondary Outcome Measures
subjects requiring re-operation of the repaired tear at the end of the follow-up period.
Comparison of number of subjects requiring re-operation of the repaired tear at the end of the follow-up period at each tratment arm.
change of total questionnaires scores from baseline to each follow-up visit.
Comparison between the change of total questionnaires scores from baseline to each follow-up visit at each treatment arm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01890733
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 Efficacy and Safety of InSpace™ Device in Comparison to Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
Very low recruitment rate
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2015 (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 .
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
Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV
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
5 (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 debridment, 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 debridment, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system.
Intervention Type
Device
Intervention Name(s)
Best Repair of torn Rotator Cuff
Intervention Type
Device
Intervention Name(s)
InSpace™ system
Primary Outcome Measure Information:
Title
Comparison of respose rate at each treatment arm
Description
The primary efficacy outcome of the study is considered as the subject response/rehabilitation rate at 6 month post implantation as assesed by the change in the Shoulder Score
Time Frame
6m
Secondary Outcome Measure Information:
Title
subjects requiring re-operation of the repaired tear at the end of the follow-up period.
Description
Comparison of number of subjects requiring re-operation of the repaired tear at the end of the follow-up period at each tratment arm.
Time Frame
24 m post implantation
Title
change of total questionnaires scores from baseline to each follow-up visit.
Description
Comparison between the change of total questionnaires scores from baseline to each follow-up visit at each treatment arm.
Time Frame
6W, 3m, 6m , 12m ,24m
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 (CT arthrogram or MRI)* of the affected shoulder indicating full thickness Massive RCT of at least 5cm in diameter (according to Cofield classification) or long - narrow tears of at least 4cm2 (W>2cm and L>2cm) including fatty infiltration grade III or IV (according to classification of Goutallier) 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
Luigi Solimeno, MD
Organizational Affiliation
Policlinico de Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico
City
Milano
Country
Italy
12. IPD Sharing Statement
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InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
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