Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Baxter Healthcare Corporation
With
Synovis Surgical Innovations
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Ages 18-70
MRI confirmed full thickness or high grade partial thickness rotator cuff tear equal or more than 1 cm and involving the supraspinatus and/or infraspinatus tendons
Tear is repairable by surgery using protocol prescribed fixation procedure
Patient is able to sign and IRB approved study informed consent
Patient is willing and able to return for follow-up appointments and study related procedures
Patient is willing to comply with prescribed physical therapy regimen
You may not be if
Emergency, poly trauma patients
Prior same shoulder surgery including rotator cuff repair except prior subacromial decompression or distal clavicle resection
Shoulder pathology requiring concomitant procedures during the rotator cuff repair including Labral repair, anterior or posterior stabilization, and/or capsular plication or shift
Cervical spine disease
History of adhesive capsulitis in either shoulder
Patient whose injury does or may involve litigation
Diabetics
Rotator cuff tear cannot be repaired by primary surgical means including superiorly migrated humeral head, retracted rotator cuff that cannot be mobilized to humeral head, end stage tears, rotator cuff tissue cannot retain sutures, any comorbidities that would directly or indirectly affect the reparability of the cuff
Patients with grade 3 or 4 glenohumeral arthritis
Patients with systemic collage disease
Patients with a known hypersensitivity to equine derived materials
Active or latent infection
Chronic use of immunosuppressive agents
Any oral or IM NSAID usage within 5 days before surgery
Cancer patients
Decisional impaired patients
Pregnant women
Clareo Health | Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation
