Effect of ACP on Surgical Repair of Rotator Cuff Tears

Effect of Autologous Plasma (ACP) on Surgical Repair of Rotator Cuff Tears

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Device: Autologous conditioned plasma; Device: Control group

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 Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton Zürich
    • Zürich, Canton Zürich, Switzerland, 8008
      • Schulthess Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACP treated; The patients are going to get an injection of 4mL autologous conditioned plasma under the footprint following an arthroscopic repair of the rotator cuff.	Device: Autologous conditioned plasma; 4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.; Other Names: ACP Arthrex
Placebo Comparator: Control group; The patients are going to get an injection of 4mL saline solution under the footprint following an arthroscopic repair of the rotator cuff.	Device: Control group; 4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.; Other Names: ACP Arthrex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Shoulder Score	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.	3mo (6mo/24mo)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Schulthess Klinik
• Collaborators: Arthrex, Inc.

Publications and helpful links

General Publications

• Flury M, Rickenbacher D, Schwyzer HK, Jung C, Schneider MM, Stahnke K, Goldhahn J, Audige L. Does Pure Platelet-Rich Plasma Affect Postoperative Clinical Outcomes After Arthroscopic Rotator Cuff Repair? A Randomized Controlled Trial. Am J Sports Med. 2016 Aug;44(8):2136-46. doi: 10.1177/0363546516645518. Epub 2016 May 16.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: December 22, 2010
• First Submitted That Met QC Criteria: December 23, 2010
• First Posted (Estimate): December 24, 2010

Study Record Updates

• Last Update Posted (Estimate): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 19, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: ACP; Rotator cuff tears
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: ACP01; KEK-ZH-Nr. 2010-0309/4 (Other Identifier: Regional Ethics Committee of Zurich)