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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01890733

Enrollment

Registered

2013-07-02

Start date

2012-09-30

Completion date

2015-09-30

Last updated

2020-06-04

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

Conditions

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

Keywords

Massive Rotator Cuff Tear, Sub-acromial spacer, Best repair of rotator cuff,

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).

Interventions

DEVICEBest Repair of torn Rotator Cuff

DEVICEInSpace™ system

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

40 Years to 95 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison of respose rate at each treatment arm	6m	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

Secondary

Measure	Time frame	Description
subjects requiring re-operation of the repaired tear at the end of the follow-up period.	24 m post implantation	Comparison of number of subjects requiring re-operation of the repaired tear at the end of the follow-up period at each tratment arm.
change of total questionnaires scores from baseline to each follow-up visit.	6W, 3m, 6m , 12m ,24m	Comparison between the change of total questionnaires scores from baseline to each follow-up visit at each treatment arm.

Countries

Italy

Outcome results

None listed

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