Effect of ACP on Surgical Repair of Rotator Cuff Tears

Not Applicable

Completed

• Conditions: Rotator Cuff Tears

• Registration Number: NCT01266226
• Lead Sponsor: Schulthess Klinik

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 successful surgery is the fixation of the tendon at the bone insertion site. Tendon belongs to the bradytrophic tissue conditional on the reduced blood flow, deep mitosis rate and lowered healing potential. We can boost the healing process with a selective use of PRP (platelet rich plasma). In this process, the healing site is delivered with an elevated concentration of thrombocytes and also growth factors which are constituent parts of them.

In this study, we will test the Arthrex® Double Syringe System. With this system it is possible to obtain ACP (Autologous conditioned plasma) in one centrifugation step. The supernatant contains a concentration of thrombocytes which is twice as high as in the native blood. The concentration of the growth factors is 5-25x higher according to this.

We also want to test if one application of ACP is enough to get a short- and long-term benefit in healing following a rotator cuff tear.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2010-12-23
• Study First Posted: 2010-12-24
• Primary Completion: 2013-02
• Study Completion: 2015-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oxford Shoulder Score	3mo (6mo/24mo)	The Oxford Shoulder Score used after 3 months is the primary parameter. The Score tests the ability to participate in the patients' normal life before they got injured.

Secondary Outcome Measures

Name	Time	Method
EQ-5D	3/6/24 mo
VAS Pain	10d po
MRI/X-Ray/Ultrasonic Diagnostics	6/24 mo
ASES Score	3/6/24mo
Constant Murley Score	3/6/24 mo
Measurement of the external rotation strenght	3/6/24 mo
QuickDASH	3/6/24mo
Measurement of the abduction strength	3/6/24 mo
ROM	3/6/24mo

Trial Locations

Locations (1)

Schulthess Klinik; 🇨🇭 Zürich, Canton Zürich, Switzerland