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

NCT ID: NCT02210910

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2018-04-30

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).

Conditions

Rotator Cuff Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Best Repair of torn Rotator Cuff

Intervention Type: PROCEDURE

InSpace™ system

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.

Group Type: ACTIVE_COMPARATOR

InSpace™ system over repair

Intervention Type: DEVICE

Interventions

InSpace™ system over repair

Intervention Type: DEVICE

Best Repair of torn Rotator Cuff

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OrthoSpace Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assuta Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

IS-CL-02-01

Identifier Type: -

Identifier Source: org_study_id