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A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

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ClinicalTrials.gov Identifier: NCT02493660
Recruitment Status : Completed
First Posted : July 9, 2015
Results First Posted : July 22, 2021
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
OrthoSpace Ltd.

Tracking Information
First Submitted Date  ICMJE July 1, 2015
First Posted Date  ICMJE July 9, 2015
Results First Submitted Date  ICMJE May 19, 2021
Results First Posted Date  ICMJE July 22, 2021
Last Update Posted Date June 15, 2022
Actual Study Start Date  ICMJE June 26, 2015
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2022)
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. [ Time Frame: Baseline to month 12 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2015)
  • Evaluate the safety as measured by adverse events frequency to study treatment and control treatment [ Time Frame: At each follow up visit up to 2 years post operation ]
    To evaluate the safety of the InSpace device as a primary surgical treatment for full thickness massive rotator cuff tears
  • Change in Western Ontario Rotator Cuff Index (WORC) compared to baseline [ Time Frame: 12 months post operation ]
    An improvement in WORC scores at 12 month post-operation compared to baseline
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2022)
  • 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 [ Time Frame: Baseline through to Month 24 ]
    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) [ Time Frame: Baseline to month 12 ]
    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) [ Time Frame: Baseline to month 12 ]
    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 [ Time Frame: Baseline through to month 24 ]
    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 [ Time Frame: Baseline through to month 24 ]
    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 [ Time Frame: Baseline to month 24 ]
    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 [ Time Frame: Baseline through to month 24 ]
    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 [ Time Frame: Baseline through to month 24 ]
    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 [ Time Frame: Baseline through to month 24 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2015)
  • Change in American Shoulder and Elbow Surgeons (ASES) score [ Time Frame: Up to 2 years post operation ]
    Change in ASES from baseline shoulder scores from baseline to each follow-up visit
  • Change in Constant shoulder outcome score [ Time Frame: Up to 2 years post operation ]
    Change in Constant shoulder scores from baseline to each follow-up visit
  • Change in Quality of Life compared to baseline [ Time Frame: Up to 2 years post operation ]
    Change in EuroQOL(EQ-5D-5L) five dimensions questionnaire from baseline to each follow-up visit
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Rotator Cuff Syndrome
Intervention  ICMJE
  • Device: InSpace sub-acromial tissue spacer system
    Arthroscopic implantation of InSpace sub-acromial tissue spacer system
  • Procedure: Partial repair of rotator cuff
    Arthroscopic partial repair of rotator cuff
Study Arms  ICMJE
  • Experimental: InSpace implantation
    Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation
    Intervention: Device: InSpace sub-acromial tissue spacer system
  • Active Comparator: Tendon Repair
    Arthroscopic partial repair of rotator cuff
    Intervention: Procedure: Partial repair of rotator cuff
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2015)
184
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 17, 2020
Actual Primary Completion Date February 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    1. significant gleno-humeral or acromiohumeral arthritis
    2. full thickness cartilage loss as seen on MRI
    3. gleno-humeral instability (excessive translation of the humeral head on the glenoid fossa)
    4. pre-existing deltoid defect or deltoid palsy
    5. major joint trauma, infection or necrosis
    6. partial thickness tears of the supraspinatous
    7. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02493660
Other Study ID Numbers  ICMJE CLD-OR-010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party OrthoSpace Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE OrthoSpace Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Assaf Dekel, MD Ortho-Space
PRS Account OrthoSpace Ltd.
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP