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

OrthoSpace

Status: Completed

Conditions: Rotator Cuff Tear

Treatments: Procedure: Best Repair of torn Rotator Cuff; Device: InSpace™ system over repair

Study type: Interventional

Funder types: Industry

Identifiers

NCT02210910

IS-CL-02-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 39 patients

Sex: All

Ages: 40 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 -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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups

Best Repair of torn Rotator Cuff

Sham Comparator group

Description:

Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.

Treatment:

Procedure: Best Repair of torn Rotator Cuff

InSpace™ system

Active Comparator group

Description:

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.

Treatment:

Device: InSpace™ system over repair