Brief Description

This study will involve 184 patients, at up to 20 medical centers across North America. Information will be collected on the participants, all of whom have a full thickness massive rotator cuff tear. Arthroscopic surgery will be used for all participants. During this type of surgery, 2-3 small incisions are made around the shoulder instead of a single large incision.

During surgery, randomization will be performed. The treatment assignment will be either the investigational treatment (InSpace device) or the control treatment (Partial Repair). This will be determined by a random process (like flipping a coin). For this study a 1:1 ratio will be used, meaning that there is approximately a 50% (1 in 2) chance of receiving the investigational treatment and a 50% (1 in 2) chance of receiving control treatment. If randomized to Group I (InSpace device), no attempt at a rotator cuff repair is made; instead, the InSpace balloon will be arthroscopically implanted. Group I (InSpace device) patients will receive arthroscopic debridement (removing any scar tissue or shaving down bone spurs in the shoulder joint) without any type of rotator cuff repair. If randomized to Group II (partial repair), patients will undergo a partial rotator cuff repair, which involves suture and anchor placement in the tendons of the shoulder, in addition to arthroscopic debridement.

Patients taking part in the study will be asked to visit the research center for scheduled appointments during the 24 months following surgery. Follow-up visits will be required at 10 days after surgery, 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery.

The study is blinded meaning that study participants will not be told which treatment they have received until the study is completed.

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Disclaimer: Investigational Device. Limited by US law to investigational use

Aug 2, 2016 | Posted by | Comments Off on Clinical Study
Disclaimer: The InSpace™ system is approved for marketing in Europe but is not approved yet for marketing in the USA. This material should be considered informational only and does not constitute an offer to sell in any jurisdiction in which this product is not yet permitted to be sold.
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