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NCT02210910 Clinical Trial

InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.

Rotator Cuff Tear Clinical Trial

Official title:
A Randomized, Two-arm, Prospective Study to Assess the Efficacy and Safety of InSpace™ Device Implanted Over a Rotator Cuff Repair in Comparison With Rotator Cuff Repair Only

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02210910
Other study ID # IS-CL-02-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2012
Est. completion date April 2018

Study information
Verified date August 2018
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™ in the study population in comparison to surgical RCT repair.

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 Completed
Enrollment 39
Est. completion date April 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 40 Years to 95 Years
Eligibility Main Inclusion Criteria:

- Age 40 or older.

- Positive diagnostic MRI of the affected shoulder indicating full thickness large to massive RCT of at least 3cm in diameter (according to Cofield classification2) involving one or more tendons. (MRI can be done up to 6 months prior to randomization.)

- 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

Device:
• InSpace™ system over repair

Procedure:
• Best Repair of torn Rotator Cuff

Locations
Country Name City State
Israel Assuta Medical Center Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
OrthoSpace Ltd.

Country where clinical trial is conducted

Israel, 

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