InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: 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. |
Device: Best Repair of torn Rotator Cuff
|
| Active Comparator: 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. |
Device: InSpace™ system
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
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 :
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Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
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Evidence of significant osteoarthritis or cartilage damage in the shoulder
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Evidence of gleno-humeral instability
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Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
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Evidence of major joint trauma, infection, or necrosis in the shoulder
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Partial-thickness tears of the rotator cuff
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Policlinico | Milano | Italy |
Sponsors and Collaborators
- OrthoSpace Ltd.
Investigators
- Principal Investigator: Luigi Solimeno, MD, Policlinico de Milano
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IS-CL-02