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NCT02211183 Clinical Trial

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

Rotator Cuff Tear Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02211183
Other study ID # IS-CL-02-SP
Secondary ID
Status Terminated
Phase N/A
First received August 6, 2014
Last updated April 4, 2018
Start date August 2014
Est. completion date February 2016

Study information
Verified date May 2016
Source OrthoSpace Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .

Description:

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).

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date February 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 40 Years to 95 Years
Eligibility Main Inclusion Criteria:

- Age 40 or older.

- Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT (according to Cofield classification) or long 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 -?-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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Best Repair of torn Rotator Cuff

Device:
• InSpace™ system

Locations
Country Name City State
Spain Fundacion Jimenez Diaz Madrid

Sponsors (1)
Lead Sponsor Collaborator
OrthoSpace Ltd.

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary The change in Shoulder Score from baseline baseline and 6 months
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