Back to resultsA Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
Primary Purpose
Rotator Cuff Syndrome
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
InSpace sub-acromial tissue spacer system
Partial repair of rotator cuff
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Syndrome focused on measuring Massive Rotator Cuff Tear, Arthroscopy, Shoulder Joint, Rotator cuff partial repair
Eligibility Criteria
Main Inclusion Criteria:
- Positive diagnostic imaging by MRI of the index shoulder indicating a full thickness Massive Rotator Cuff Tear (MRCT), measuring ≥ 5 cm in diameter involving ≥ two tendons (confirmed Intra-operatively)
- Functional deltoid muscle and preserved passive range of motion on physical examination
- Documented VAS score of > 30 mm pain
- Failed non-operative treatment of at least 4 months
- Patient in general good health,independent, and can comply with all post-operative evaluations and visits.
Main Exclusion Criteria:
- Known allergy to the device material (copolymer of PLA and -ε-caprolactone)
Evidence of the following conditions:
- significant gleno-humeral or acromiohumeral arthritis
- full thickness cartilage loss as seen on MRI
- gleno-humeral instability (excessive translation of the humeral head on the glenoid fossa)
- pre-existing deltoid defect or deltoid palsy
- major joint trauma, infection or necrosis
- partial thickness tears of the supraspinatous
- fully reparable rotator cuff tear [Tear of less than 5 cm in diameter (or < 4 cm2) with retractable tendon that can be fully repaired]
- The subject requires concomitant subscapularis repair and/or labral repair
- Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy
- The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder
- Major medical condition that could affect quality of life and influence the results of the study (e.g. HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA, etc.)
- Documented evidence of a history of drug/alcohol abuse within 12 months of enrollment
- The subject's condition represents a worker's compensation case
- The subject is currently involved in a health-related litigation procedure
- Females of child-bearing potential who are pregnant or breastfeeding or plan to become pregnant during the course of the study
- Concurrent participation in any other investigational clinical study one month prior to enrollment or during the entire study period
- The subject has implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing a MRI scan or has claustrophobia that would inhibit ability to undergo a MRI scan .
- The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up
- The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition
- The subject currently has an acute infection in the area surrounding the surgical site.
Sites / Locations
- Southern California Orthopedic Institute
- University of Colorado
- Holy Cross Hospital
- Midwest Orthopedics at RUSH
- Rockford Orthopedic Associates
- Tulane University School of Medicine
- Johns Hopkins
- MedStar Union Memorial Orthopaedics
- Brigham & Women's Hospital
- NYU
- Columbia University Medical Center
- University of Buffalo Buffalo
- Upstate Orthopedics
- Cincinnati SportsMedicine and Orthopaedic Center - Mercy Health
- The Ohio State University
- Rothman Institute
- University Orthopedic Center
- University of Texas Southwestern Medical Center
- Fowler Kennedy Sport Medicine Clinic
- Roth McFarlane Hand and Upper Limb Center
- Ottawa Hospital Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
InSpace implantation
Tendon Repair
Arm Description
Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation
Arthroscopic partial repair of rotator cuff
Outcomes
Primary Outcome Measures
Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs.
The primary composite effectiveness endpoint was defined as achievement of improvement for the Western Ontario Rotator Cuff (WORC) score (≥275 points) and American Shoulder and Elbow Society (ASES) score (≥6.4 points) by week 6 and maintenance at month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).
The improvement of points of the Western Ontario Rotator Cuff (WORC) of at least 275 (point scale of 0-2100:lower score is better) and American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.
Secondary Outcome Measures
Composite Endpoint of WORC Improvement ≥275 and ASES Improvement ≥6.4 at Week 6 Maintained at Month 24 no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (Pre-specified). Composite WORC ASES and Safety to M24
Composite Endpoint Per Protocol Population (PP) of WORC Improvement ≥ 275 and ASES Improvement ≥ 6.4 from baseline at Week 6 Maintained at Month 24 with no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (pre-specified).
Composite Endpoint Component Level Success for WORC at Month 12 Compared to Baseline in the Per Protocol Population (PP)
The secondary effectiveness endpoint was defined as a composite component-level success at Month 12 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).
Composite Endpoint Component Level Success for ASES at Month 12 Compared to Baseline in the Per Protocol Population (PP)
The secondary endpoint was defined as a composite component-level success for American Shoulder and Elbow Surgeons ( ASES) compared at baseline to Month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs)..
The total score improvement of (≥ 6.4 points) (scale of 0-100:higher score is better) from baseline in the two groups, InSpace and Partial Repair.
Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. WORC
The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair.
Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. ASES
Mean change in American Shoulder and Elbow Surgeons (ASES) score from baseline to month 24.
The improvement of points of the American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.
Mean Change From Baseline to Month 24 for Constant-Murley (CS) in the Intent To Treat Population (ITT) With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Constant-Murley (CS) Shoulder Outcome score (where the scale of 0-100:higher score is better) in the two groups, InSpace and Partial Repair.
The Mean Change From Baseline to Month 24 for EQ-5D-5L for Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
The secondary effectiveness endpoint was defined as change in baseline to Month 24 for Quality of Life (EQ-5D-5L) (scale of 0-100: lower score better) in the two groups, InSpace and Partial Repair.
Mean Change From Baseline to Month 24 for VAS in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
The secondary effectiveness endpoint was defined as the mean change from baseline at Month 24 for Visual Analogue Scale (VAS) (scale of 0-100:lower score is better) in the two groups, InSpace and Partial Repair.
Mean Change From Baseline to Month 24 for ASES ROM in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
The secondary effectiveness endpoint was defined as mean change from baseline at Month 24 for American Shoulder and Elbow Surgeons (ASES) range of motion (ROM)-physician reported portion. (scale of 0-180 Degrees: higher score is better) in the two groups, InSpace and Partial Repair.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02493660
Brief Title
A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
Official Title
A Prospective, Single Blinded, Multi-center, Randomized, Controlled, Pivotal Study to Assess the Safety and Effectiveness of the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 26, 2015 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
March 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrthoSpace Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).
Detailed Description
This is a non-inferiority, prospective, single blinded, multi-center, randomized, controlled, pivotal study evaluating the safety and effectiveness of the InSpace™ device as a primary surgical treatment for full thickness MRCT in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Syndrome
Keywords
Massive Rotator Cuff Tear, Arthroscopy, Shoulder Joint, Rotator cuff partial repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
InSpace implantation
Arm Type
Experimental
Arm Description
Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation
Arm Title
Tendon Repair
Arm Type
Active Comparator
Arm Description
Arthroscopic partial repair of rotator cuff
Intervention Type
Device
Intervention Name(s)
InSpace sub-acromial tissue spacer system
Intervention Description
Arthroscopic implantation of InSpace sub-acromial tissue spacer system
Intervention Type
Procedure
Intervention Name(s)
Partial repair of rotator cuff
Intervention Description
Arthroscopic partial repair of rotator cuff
Primary Outcome Measure Information:
Title
Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs.
Description
The primary composite effectiveness endpoint was defined as achievement of improvement for the Western Ontario Rotator Cuff (WORC) score (≥275 points) and American Shoulder and Elbow Society (ASES) score (≥6.4 points) by week 6 and maintenance at month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).
The improvement of points of the Western Ontario Rotator Cuff (WORC) of at least 275 (point scale of 0-2100:lower score is better) and American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.
Time Frame
Baseline to month 12
Secondary Outcome Measure Information:
Title
Composite Endpoint of WORC Improvement ≥275 and ASES Improvement ≥6.4 at Week 6 Maintained at Month 24 no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (Pre-specified). Composite WORC ASES and Safety to M24
Description
Composite Endpoint Per Protocol Population (PP) of WORC Improvement ≥ 275 and ASES Improvement ≥ 6.4 from baseline at Week 6 Maintained at Month 24 with no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (pre-specified).
Time Frame
Baseline through to Month 24
Title
Composite Endpoint Component Level Success for WORC at Month 12 Compared to Baseline in the Per Protocol Population (PP)
Description
The secondary effectiveness endpoint was defined as a composite component-level success at Month 12 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).
Time Frame
Baseline to month 12
Title
Composite Endpoint Component Level Success for ASES at Month 12 Compared to Baseline in the Per Protocol Population (PP)
Description
The secondary endpoint was defined as a composite component-level success for American Shoulder and Elbow Surgeons ( ASES) compared at baseline to Month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs)..
The total score improvement of (≥ 6.4 points) (scale of 0-100:higher score is better) from baseline in the two groups, InSpace and Partial Repair.
Time Frame
Baseline to month 12
Title
Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. WORC
Description
The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair.
Time Frame
Baseline through to month 24
Title
Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. ASES
Description
Mean change in American Shoulder and Elbow Surgeons (ASES) score from baseline to month 24.
The improvement of points of the American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.
Time Frame
Baseline through to month 24
Title
Mean Change From Baseline to Month 24 for Constant-Murley (CS) in the Intent To Treat Population (ITT) With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
Description
The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Constant-Murley (CS) Shoulder Outcome score (where the scale of 0-100:higher score is better) in the two groups, InSpace and Partial Repair.
Time Frame
Baseline to month 24
Title
The Mean Change From Baseline to Month 24 for EQ-5D-5L for Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
Description
The secondary effectiveness endpoint was defined as change in baseline to Month 24 for Quality of Life (EQ-5D-5L) (scale of 0-100: lower score better) in the two groups, InSpace and Partial Repair.
Time Frame
Baseline through to month 24
Title
Mean Change From Baseline to Month 24 for VAS in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
Description
The secondary effectiveness endpoint was defined as the mean change from baseline at Month 24 for Visual Analogue Scale (VAS) (scale of 0-100:lower score is better) in the two groups, InSpace and Partial Repair.
Time Frame
Baseline through to month 24
Title
Mean Change From Baseline to Month 24 for ASES ROM in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
Description
The secondary effectiveness endpoint was defined as mean change from baseline at Month 24 for American Shoulder and Elbow Surgeons (ASES) range of motion (ROM)-physician reported portion. (scale of 0-180 Degrees: higher score is better) in the two groups, InSpace and Partial Repair.
Time Frame
Baseline through to month 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Positive diagnostic imaging by MRI of the index shoulder indicating a full thickness Massive Rotator Cuff Tear (MRCT), measuring ≥ 5 cm in diameter involving ≥ two tendons (confirmed Intra-operatively)
Functional deltoid muscle and preserved passive range of motion on physical examination
Documented VAS score of > 30 mm pain
Failed non-operative treatment of at least 4 months
Patient in general good health,independent, and can comply with all post-operative evaluations and visits.
Main Exclusion Criteria:
Known allergy to the device material (copolymer of PLA and -ε-caprolactone)
Evidence of the following conditions:
significant gleno-humeral or acromiohumeral arthritis
full thickness cartilage loss as seen on MRI
gleno-humeral instability (excessive translation of the humeral head on the glenoid fossa)
pre-existing deltoid defect or deltoid palsy
major joint trauma, infection or necrosis
partial thickness tears of the supraspinatous
fully reparable rotator cuff tear [Tear of less than 5 cm in diameter (or < 4 cm2) with retractable tendon that can be fully repaired]
The subject requires concomitant subscapularis repair and/or labral repair
Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy
The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder
Major medical condition that could affect quality of life and influence the results of the study (e.g. HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA, etc.)
Documented evidence of a history of drug/alcohol abuse within 12 months of enrollment
The subject's condition represents a worker's compensation case
The subject is currently involved in a health-related litigation procedure
Females of child-bearing potential who are pregnant or breastfeeding or plan to become pregnant during the course of the study
Concurrent participation in any other investigational clinical study one month prior to enrollment or during the entire study period
The subject has implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing a MRI scan or has claustrophobia that would inhibit ability to undergo a MRI scan .
The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up
The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition
The subject currently has an acute infection in the area surrounding the surgical site.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assaf Dekel, MD
Organizational Affiliation
Ortho-Space
Official's Role
Study Director
Facility Information:
Facility Name
Southern California Orthopedic Institute
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Midwest Orthopedics at RUSH
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rockford Orthopedic Associates
City
Rockford
State/Province
Illinois
ZIP/Postal Code
51107
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205-1911
Country
United States
Facility Name
MedStar Union Memorial Orthopaedics
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02166
Country
United States
Facility Name
NYU
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Buffalo Buffalo
City
New York
State/Province
New York
ZIP/Postal Code
14260
Country
United States
Facility Name
Upstate Orthopedics
City
Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Cincinnati SportsMedicine and Orthopaedic Center - Mercy Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45209
Country
United States
Facility Name
The Ohio State University
City
Ohio City
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
University Orthopedic Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Fowler Kennedy Sport Medicine Clinic
City
London
State/Province
Ontario
Country
Canada
Facility Name
Roth McFarlane Hand and Upper Limb Center
City
London
State/Province
Ontario
Country
Canada
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
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