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InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.

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: NCT02208440
Recruitment Status : Terminated (Enrollment target has not achieved due to very slow and low recruitment rate)
First Posted : August 5, 2014
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
OrthoSpace Ltd.

Brief Summary:
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .

Condition or disease Intervention/treatment Phase
Full-thickness Rotator Cuff Tear Procedure: Best Repair of torn Rotator Cuff Device: InSpace™ system Not Applicable

Detailed Description:

This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .

The effectiveness will be assessed by comparing the shoulder outcome scores of each treatment arm ( ASES, Constant and Quick DASH) from pre-operation (baseline) up to 2 years post-operation, with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).

The safety will be asses by comparing the Adverse event rate between the treatment arms.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The patient is blinded to the treatment type
Primary Purpose: Treatment
Official Title: A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Safety and Efficacy of InSpace™ Device in Comparison to Full Thickness Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.
Actual Study Start Date : July 2014
Actual Primary Completion Date : July 2018
Actual Study Completion Date : January 2019

Arm Intervention/treatment
Sham Comparator: Best Repair of torn Rotator Cuff
Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.
Procedure: Best Repair of torn Rotator Cuff
Active Comparator: InSpace™ system
Subjects will undergo surgical intervention (usually arthroscopy or mini invasive) of debridement, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system.
Device: InSpace™ system



Primary Outcome Measures :
  1. The change in the Shoulder Score [ Time Frame: baseline and 6 months ]


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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Age 40 or older.
  • Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT involving more than one tendon.
  • Persistent pain and functional disability of the affected shoulder for at least 3 months.

Main Exclusion Criteria :

  • Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
  • Evidence of significant osteoarthritis or cartilage damage in the shoulder
  • Evidence of gleno-humeral instability
  • Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
  • Evidence of major joint trauma, infection, or necrosis in the shoulder
  • Partial-thickness tears of the rotator cuff

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): NCT02208440


Locations
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United Kingdom
Wigan and Leigh NHS Foundation Trust: Upper Limb & Trauma Surgery
Wigan, Hall Lane, Appley Bridge, United Kingdom, WN69EP
Sponsors and Collaborators
OrthoSpace Ltd.
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Responsible Party: OrthoSpace Ltd.
ClinicalTrials.gov Identifier: NCT02208440    
Other Study ID Numbers: IS-CL-02-UK
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by OrthoSpace Ltd.:
Full-thickness/Massive Rotator Cuff Tear, Sub-acromial spacer
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries