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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02493660
Recruitment Status : Active, not recruiting
First Posted : July 9, 2015
Last Update Posted : August 28, 2019
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.

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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
Actual Study Start Date : June 26, 2015
Actual Primary Completion Date : June 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
Show Show 21 study locations
Sponsors and Collaborators
OrthoSpace Ltd.
Investigators
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Study Director: Assaf Dekel, MD Ortho-Space

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Responsible Party: OrthoSpace Ltd.
ClinicalTrials.gov Identifier: NCT02493660    
Other Study ID Numbers: CLD-OR-010
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by OrthoSpace Ltd.:
Massive Rotator Cuff Tear
Arthroscopy
Shoulder Joint
Rotator cuff partial repair
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries