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

NCT ID: NCT01890733

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-09-30

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 .

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

Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV

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 debridment, 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: DEVICE

InSpace™ system

Subjects will undergo surgical intervention (usually arthroscopy or mini invasive) of debridment, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system.

Group Type: ACTIVE_COMPARATOR

InSpace™ system

Intervention Type: DEVICE

Interventions

Best Repair of torn Rotator Cuff

Intervention Type: DEVICE

InSpace™ system

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 40 or older.
• Positive diagnostic imaging (CT arthrogram or MRI)* of the affected shoulder indicating full thickness Massive RCT of at least 5cm in diameter (according to Cofield classification) or long - narrow tears of at least 4cm2 (W>2cm and L>2cm) including fatty infiltration grade III or IV (according to classification of Goutallier) involving more than one tendon. - 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

Principal Investigators

Luigi Solimeno, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico de Milano

Locations

Policlinico

Milan, , Italy

Countries

Italy

Other Identifiers

IS-CL-02

Identifier Type: -

Identifier Source: org_study_id