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

OrthoSpace Ltd.5 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 . 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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

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

Interventions

Best Repair of torn Rotator CuffDEVICE

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 (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. 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)

Policlinico

Milan, Italy

Outcomes

Primary Outcomes

Comparison of respose rate at each treatment arm

The primary efficacy outcome of the study is considered as the subject response/rehabilitation rate at 6 month post implantation as assesed by the change in the Shoulder Score

Time frame: 6m

Secondary Outcomes

subjects requiring re-operation of the repaired tear at the end of the follow-up period.

Comparison of number of subjects requiring re-operation of the repaired tear at the end of the follow-up period at each tratment arm.

Time frame: 24 m post implantation

change of total questionnaires scores from baseline to each follow-up visit.

Comparison between the change of total questionnaires scores from baseline to each follow-up visit at each treatment arm.

Time frame: 6W, 3m, 6m , 12m ,24m

Data from ClinicalTrials.gov

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