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

Not Applicable

Terminated

• Conditions: Full-thickness Rotator Cuff Tear
• Interventions: Procedure: Best Repair of torn Rotator Cuff; Device: InSpace™ system

• Registration Number: NCT02208440
• Lead Sponsor: 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 .

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-03
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-05
• Primary Completion: 2018-07
• Study Completion: 2019-01
• Status Verified: 2019-08
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

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	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Wigan and Leigh NHS Foundation Trust: Upper Limb & Trauma Surgery; 🇬🇧 Wigan, Hall Lane, Appley Bridge, United Kingdom