Growth factors augmentation for arthroscopic rotator cuff repair

Completed

• Conditions: Rotator-cuff tendon tear; Injury, Occupational Diseases, Poisoning; Injury of muscle and tendon at shoulder and upper arm level

• Registration Number: ISRCTN49643328
• Lead Sponsor: Ospedale Civile (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-02
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. Aged over 30 years, either sex
2. Rotator cuff tear diagnosed on clinical grounds
3. No episodes of shoulder instability
4. No radiographic signs of fracture of the glenoid or the greater or lesser tuberosity
5. Magnetic resonance imaging evidence of cuff tear
6. A repairable full-thickness tear of the rotator cuff found at the time of surgery
7. Patients with associated biceps pathology are also included

Exclusion Criteria

1. Inflammatory joint disease
2. Irreparable full-thickness tear or partial thickness tear of the rotator cuff found at the time of surgery
3. Symptomatic arthritis of the acromioclavicular joint
4. Rotator cuff arthropathy
5. Pathologies of the subscapularis tendon
6. Workers' Compensation claims
7. Prior surgery on the affected shoulder
8. Inability to complete questionnaires because of language problem

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in change from baseline to 16 months in the Constant Score between the two groups. The Constant Score is a scoring system shoulder rating scale evaluating shoulder pain (15 points), activities of daily living (20 points), range of movement (40 points), and power (25 points). Total possible score is 100 points, indicating an asymptomatic and healthy person, while the worst score is 0 points.

Secondary Outcome Measures

Name	Time	Method
Integrity of the repaired rotator cuff, as evaluated by MRI.