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

Not Applicable

Completed

• Conditions: Rotator Cuff Tear
• Interventions: Procedure: Best Repair of torn Rotator Cuff; Device: InSpace™ system over repair

• Registration Number: NCT02210910
• Lead Sponsor: OrthoSpace Ltd.

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-07
• Primary Completion: 2018-03
• Study Completion: 2018-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 -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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Best Repair of torn Rotator Cuff	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.
InSpace™ system	InSpace™ system over repair	Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair, and placement of the InSpace™ system.

Primary Outcome Measures

Name	Time	Method
The change in the Shoulder Score	baseline and 6 months

Trial Locations

Locations (1)

Assuta Medical Center; 🇮🇱 Tel Aviv, Israel