Integrity Orthopaedics, Inc.
The purpose of this research study is to evaluate tendon healing when using the Flexible Suturing System with Anchors (FSSA) to surgically repair full-thickness rotator cuff tendon tears.
Inclusion Criteria: Subjects MUST meet ALL the following criteria to be included in the study: 1. Underwent surgery to repair a torn rotator cuff tear with the Flexible Suturing System with Anchors (FSSA) and is able to obtain a follow-up MRI within 12 months +4 months / -1 month from the surgery date. 2. Tear size of the supraspinatus (SSP) with or without involvement of the infraspinatus (ISP), confirmed intra-operatively or with the pre-procedural MRI, is greater than or equal to 1 cm. 3. Between 18 and 70 years old at the time of surgery. 4. Able to understand the content of the subject…
Surgically repaired full-thickness rotator cuff tendon tears with the Flexible Suturing System with Anchors (FSSA).
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