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Trial record 2 of 121 for:    inspace

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
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
OrthoSpace Ltd.

Tracking Information
First Submitted Date  ICMJE July 1, 2015
First Posted Date  ICMJE July 9, 2015
Last Update Posted Date June 24, 2020
Actual Study Start Date  ICMJE June 26, 2015
Actual Primary Completion Date March 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
  • To evaluate the safety and effectiveness of the InSpace device as a primary surgical treatment for full-thickness massive rotator cuff tears. A composite endpoint requiring each of the following to be met to declare patient-level success [ Time Frame: At each follow up visit up to 1 years post operation ]
    WORC total score improvement of ≥275 points by Week 6 from pre-operative baseline and maintained at Month 12
  • Composite endpoint for ASES scores [ Time Frame: At each follow up visit up to 1 years post operation ]
    ASES overall score improvement of ≥6.4 points by Week 6 from pre-operative baseline and maintained at Month 12;
  • No subsequent secondary surgical interventions (SSSIs) in index shoulder [ Time Frame: Up to 2 years post operation ]
    No subsequent secondary surgical interventions ("SSSIs") in the index shoulder through Month 12;
  • To have an absence of serious adverse device effects (SADEs) [ Time Frame: Up to 2 years post operation ]
    Absence of serious adverse device effects ("SADEs"), through Month 12.
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 22, 2020)
  • Composite change in Western Ontario Rotator Cuff (WORC) score [ Time Frame: At each follow up visit up to 2 years post operation ]
    Composite endpoint component-level success for WORC total score compared to baseline;
  • Composite change in American Shoulder and Elbow Surgeons (ASES) score [ Time Frame: At each follow up visit up to 2 years post operation ]
    Composite endpoint component-level success for ASES overall score compared to baseline
  • Change in Western Ontario Rotator Cuff (WORC) score [ Time Frame: At each follow up visit up to 2 years post operation ]
    Change in WORC total score from baseline
  • Change in American Shoulder and Elbow Surgeons (ASES) score [ Time Frame: At each follow up visit up to 2 years post operation ]
    Change in ASES overall score from baseline
  • Change in Constant-Murley Shoulder Outcome score [ Time Frame: At each follow up visit up to 2 years post operation ]
    Change in Constant shoulder scores from baseline to each follow-up visit
  • Change in Quality of Life (EQ-5D-6L) score [ Time Frame: At each follow up visit up to 2 years post operation ]
    Change in EuroQOL(EQ-5D-5L) five dimensions questionnaire from baseline to each follow-up visit
  • Change in Visual analogue scale (VAS) [ Time Frame: At each follow up visit up to 2 years post operation ]
    Change in visual analogue scale ("VAS") pain score from baseline;
  • Change in range of motion (ROM) (ASES) [ Time Frame: At each follow up visit up to 2 years post operation ]
    Change in range of motion ("ROM") (ASES Physician Assessment) from baseline.
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 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 February 29, 2020
Actual Primary Completion Date March 6, 2019   (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
Responsible Party OrthoSpace Ltd.
Study Sponsor  ICMJE OrthoSpace Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Assaf Dekel, MD Ortho-Space
PRS Account OrthoSpace Ltd.
Verification Date March 2020

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