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. Identifier: NCT02208440
Recruitment Status : Active, not recruiting
First Posted : August 5, 2014
Last Update Posted : August 22, 2018
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 .

The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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 ]

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT02208440

United Kingdom
Wigan And Leigh NHS Foundation Trust, Hall Lane, Appley Bridge, United Kingdom, WN69EP
Sponsors and Collaborators
OrthoSpace Ltd.

Responsible Party: OrthoSpace Ltd. Identifier: NCT02208440     History of Changes
Other Study ID Numbers: IS-CL-02-UK
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

Keywords provided by OrthoSpace Ltd.:
Massive Rotator Cuff Tear, Sub-acromial spacer, Best repair of rotator cuff

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