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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 : Active, not recruiting
First Posted : July 9, 2015
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
OrthoSpace Ltd.

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).

Condition or disease Intervention/treatment Phase
Rotator Cuff Syndrome Device: InSpace sub-acromial tissue spacer system Procedure: Partial repair of rotator cuff Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : July 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: InSpace implantation
Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation
Device: InSpace sub-acromial tissue spacer system
Arthroscopic implantation of InSpace sub-acromial tissue spacer system

Active Comparator: Tendon Repair
Arthroscopic partial repair of rotator cuff
Procedure: Partial repair of rotator cuff
Arthroscopic partial repair of rotator cuff




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493660


Locations
United States, California
Southern California Orthopedic Institute
Van Nuys, California, United States, 91405
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80222
United States, Florida
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33334
United States, Illinois
Midwest Orthopedics at RUSH
Chicago, Illinois, United States, 60612
Rockford Orthopedic Associates
Rockford, Illinois, United States, 51107
United States, Louisiana
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21205-1911
MedStar Union Memorial Orthopaedics
Baltimore, Maryland, United States, 21218
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02166
United States, New York
NYU
New York, New York, United States, 10016
Columbia University Medical Center
New York, New York, United States, 10032
University of Buffalo Buffalo
New York, New York, United States, 14260
Upstate Orthopedics
Syracuse, New York, United States, 13057
United States, Ohio
Cincinnati SportsMedicine and Orthopaedic Center - Mercy Health
Cincinnati, Ohio, United States, 45209
The Ohio State University
Ohio City, Ohio, United States, 43210
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19152
University Orthopedic Center
State College, Pennsylvania, United States, 16801
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Canada, Ontario
Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada
Roth McFarlane Hand and Upper Limb Center
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Sponsors and Collaborators
OrthoSpace Ltd.
Investigators
Study Director: Assaf Dekel, MD Ortho-Space

Responsible Party: OrthoSpace Ltd.
ClinicalTrials.gov Identifier: NCT02493660     History of Changes
Other Study ID Numbers: CLD-OR-010
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by OrthoSpace Ltd.:
Massive Rotator Cuff Tear
Arthroscopy
Shoulder Joint
Rotator cuff partial repair

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries