Scaffold Implant for Rotator Cuff Lesions Encountered on the Supraspinatus Tendo

Recruiting

• Conditions: Supraspinatus tendon tears; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12611001082998
• Lead Sponsor: Rotation Medical, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Patients requiring surgical rotator cuff treatment of a partial- or small full-thickness tear of the supraspinatus tendon, as determined jointly by the surgeon and the patient.

Patients with chronic shoulder pain lasting longer than three months and resistant to pain medication and conservative treatment.

Patients over 40 years and under 65 years of age at time of surgery.

Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up and rehabilitation.

Patients who are capable of, and have given informed consent to their participation in the study.

Exclusion Criteria

Patients with instability of the index shoulder.

Patients with grade 3 or greater chondromalacia of the index shoulder.

Patients who require concomitant procedures other than acromioplasty/subacromial decompression, acromioclavicular joint resection, or biceps tenotomy/tenodesis at least 2 cm distal to the site of supraspinatus tendon treatment.

Patients with evidence of calcification of the rotator cuff of the index shoulder.

Patients with evidence of grade 2 fatty infiltration or greater of the supraspinatus muscle of the index shoulder on a sagittal view of an MRI scan.

Patients with insulin dependent diabetes or other autoimmune or immune deficiency disorders.

Patients with genetic collagen disease.

Patients with chronic inflammatory disease.

Pregnant women or those seeking to become pregnant.

Patients who have had previous rotator cuff shoulder surgery on the index shoulder.

Patients with a history of oral steroid use in the last 2 months or injectable steroid use in the last 4 weeks.

Patients with an inability to complete post-surgery physical therapy or return for follow-up visits.

Patients who have been heavy smokers within the last 6 months (more than 20 cigarettes per day).

Patients with a known history of hypersensitivity to bovine-derived materials.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Supraspinatus tendon thickness as assessed by Magnetic Resonance Imaging (MRI)[at baseline and at 3, 6, and 12 months]