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Trial record 1 of 2 for:    inspace pivotal
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A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

This study is currently recruiting participants.
Verified September 2017 by OrthoSpace Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02493660
First Posted: July 9, 2015
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
OrthoSpace Ltd.
  Purpose
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 Intervention
Rotator Cuff Syndrome Device: InSpace sub-acromial tissue spacer system Procedure: Partial repair of rotator cuff

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by OrthoSpace Ltd.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 184
Study Start Date: July 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 100 Years   (Adult, Senior)
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.
  Contacts and Locations
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


Contacts
Contact: Heather Neill, RN 512-621-4734 heather@orthospace.co.il

Locations
United States, California
Southern California Orthopedic Institute Recruiting
Van Nuys, California, United States, 91405
Contact: Rosa Bautista       RBautista@scoi.com   
Principal Investigator: Stephen Snyder, MD         
Sub-Investigator: Michael Bahk, MD         
Sub-Investigator: Joe Burns, MD         
Sub-Investigator: Mark Getelman, MD         
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80222
Contact: Jessie Larson    303-724-9063    Jessie.Larson@ucdenver.edu   
Principal Investigator: Jonathan Bravman, MD         
Sub-Investigator: Eric McCarty, MD         
United States, Florida
Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33334
Contact: Elizabeth Hudak    954-489-4577    Elizabeth.Hudak@holy-cross.com   
Principal Investigator: Jonathan Levy, MD         
United States, Illinois
Midwest Orthopedics at RUSH Recruiting
Chicago, Illinois, United States, 60612
Contact: Kavita Ahuja       kavita.ahuja@rushortho.com   
Principal Investigator: Nikhil Verma, MD         
Sub-Investigator: Brian Cole, MD, MBA         
Sub-Investigator: Gregory Nicholson, MD         
Rockford Orthopedic Associates Recruiting
Rockford, Illinois, United States, 51107
Contact: Lisa foti    815-847-7078    lisa.foti@rockfordortho.com   
Principal Investigator: Scott Trenhaile, MD         
United States, Louisiana
Tulane University School of Medicine Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Maria Miller    504-988-1467    mmille19@tulane.edu   
Principal Investigator: Michael O'Brien, MD         
Sub-Investigator: Felix Savoie, MD         
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205-1911
Contact: Casey Hannan    443-546-1550    Channan1@jhmi.edu   
Principal Investigator: Uma Srikumaran, MD         
MedStar Union Memorial Orthopaedics Recruiting
Baltimore, Maryland, United States, 21218
Contact: Flossine Brown       flossine.brown@medstar.net   
Principal Investigator: Anand Murthi, M.D         
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02166
Contact: Tyler Hunt    617-732-6699    tjhunt@partners.org   
Principal Investigator: Laurence Higgins, MD,MBA         
United States, New York
NYU Recruiting
New York, New York, United States, 10016
Contact: Ariel Aponte       ariel.aponte@nyumc.org   
Principal Investigator: Laith Jazwari, MD         
Sub-Investigator: Robert Meislin, MD         
Columbia University Medical Center Recruiting
New York, New York, United States
Contact: Nicole Skursky    646-317-2940    ns3197@cumc.columbia.edu   
Principal Investigator: William Levine, M.D.         
University of Buffalo Buffalo Recruiting
New York, New York, United States
Contact: Mary Bayers-Thering    716-859-1253    MBayersThering@KaleidaHealth.org   
Principal Investigator: Matthew DiPaola, M.D         
Upstate Orthopedics Recruiting
Syracuse, New York, United States, 13057
Contact: Tina Carig    315-464-8618    craigt@upstate.edu   
Principal Investigator: Kevin Setter, M.D         
United States, Ohio
Cincinnati SportsMedicine and Orthopaedic Center - Mercy Health Recruiting
Cincinnati, Ohio, United States
Contact: Cassie Fleckenstein    513-794-8466    cfleckenstein@csmref.org   
Principal Investigator: Samer Hasan, MD, PhD         
The Ohio State University Recruiting
Ohio City, Ohio, United States
Contact: Jordan Brauning    614-293-2761    jordan.brauning@osum.edu   
Principal Investigator: Grant Jones, MD         
United States, Pennsylvania
Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States, 19152
Contact: Thema Nicholson       Thema.nicholson@rothmaninstitute.com   
Principal Investigator: Joseph Abboud, MD         
University Orthopedic Center Recruiting
State College, Pennsylvania, United States, 16801
Contact       sjepson@uoc.com   
Principal Investigator: Ed Rugusky, MD         
Sub-Investigator: Paul Sensiba, MD         
Sub-Investigator: William Tyndall, MD, PhD         
Canada, Ontario
Fowler Kennedy Sport Medicine Clinic Recruiting
London, Ontario, Canada
Contact: Stacey Wanlin       wanlin@uwo.ca   
Principal Investigator: Robert Litchfield         
Roth McFarlane Hand and Upper Limb Center Recruiting
London, Ontario, Canada
Contact: Katrina Munro       Katrina.Munro@sjhc.london.on.ca   
Principal Investigator: George Athwal, MD         
Sub-Investigator: Kenneth Faber         
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada
Contact: Sara Ruggiero    613-737-8899 ext 78920    sruggiero@ohri.ca   
Principal Investigator: Peter Lapner         
Sponsors and Collaborators
OrthoSpace Ltd.
Investigators
Study Director: Assaf Dekel, MD Ortho-Space
  More Information

Responsible Party: OrthoSpace Ltd.
ClinicalTrials.gov Identifier: NCT02493660     History of Changes
Other Study ID Numbers: CLD-OR-010
First Submitted: July 1, 2015
First Posted: July 9, 2015
Last Update Posted: September 26, 2017
Last Verified: September 2017

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