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

N/ATerminatedNCT02208440

OrthoSpace Ltd.14 enrolled

Overview

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 .

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Full-thickness Rotator Cuff Tear

Interventions

Best Repair of torn Rotator CuffPROCEDURE

InSpace™ systemDEVICE

Eligibility

Sex: ALLMin age: 40 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

Wigan and Leigh NHS Foundation Trust: Upper Limb & Trauma Surgery

Wigan, Hall Lane, Appley Bridge, United Kingdom

Outcomes

Primary Outcomes

The change in the Shoulder Score

Time frame: baseline and 6 months

Data from ClinicalTrials.gov

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