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

A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Safety and Efficacy of InSpace™ Device in Comparison to Full Thickness Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02208440

Enrollment

Registered

2014-08-05

Start date

2014-07-31

Completion date

2019-01-31

Last updated

2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Full-thickness Rotator Cuff Tear

Keywords

Full-thickness/Massive Rotator Cuff Tear, Sub-acromial spacer

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.

Interventions

PROCEDUREBest Repair of torn Rotator Cuff

DEVICEInSpace™ system

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

The patient is blinded to the treatment type

Eligibility

Sex/Gender

ALL

Age

40 Years to 95 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
The change in the Shoulder Score	baseline and 6 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026