Status:
COMPLETED
Effect of ACP on Surgical Repair of Rotator Cuff Tears
Lead Sponsor:
Schulthess Klinik
Collaborating Sponsors:
Arthrex, Inc.
Conditions:
Rotator Cuff Tears
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if autologous plasma (ACP) is beneficial for better and faster healing following an arthroscopic repair of the rotator cuff.
Detailed Description
The shoulder joint, specially the rotator cuff, is one of the most complicated joints of the human body. If the tendon has to be fixed at the bone during surgery, the weak point in obtaining a success...
Eligibility Criteria
Inclusion
- Arthroscopic rotator cuff reconstructions of degenerative or traumatic full thickness rotator cuff tears (supraspinatus and/or infraspinatus tendon) performed by Dr. Flury and Dr. Schwyzer
- Suture bridge technique
- No pregnancy at the date of the surgery for women of childbearing potential
- Signed consent form
Exclusion
- Partial reconstruction of the rotator cuff (PASTA)
- Open reconstruction
- Tendon transfer (latissimus dorsi or pectoralis major)
- Revision surgery
- Omarthrosis (Level ≥ 2 Samilson \& Prieto)
- Systemic arthritis
- Rheumatoid arthritis
- Diabetes (insulin treated)
- Requiring surgery in reconstruction of the subscapularis tendon
- Progressive fat inclusion (fatty infiltration of the rotator cuff musculature Goutallier level IV
- Acute or chronic infection
- Pathological bone metabolism
- Insufficient perfusion in the affected arm
- Neuromuscular disease in the affected arm
- Non compliance of the patient
- Disorders which handicap or inhibit the patient to follow the orders of the clinical testers
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01266226
Start Date
December 1 2010
End Date
February 1 2015
Last Update
May 20 2015
Active Locations (1)
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1
Schulthess Klinik
Zurich, Canton Zürich, Switzerland, 8008