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

OrthoSpace

Status: Terminated

Conditions: Full-thickness Rotator Cuff Tear

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02208440

IS-CL-02-UK

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 14 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 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 or mini invasive) of debridement, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system.

Treatment:

Device: InSpace™ system