Effect of ACP on Surgical Repair of Rotator Cuff Tears - Full Text View

Purpose

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.

Condition	Intervention
Rotator Cuff Tears	Device: Autologous conditioned plasma Device: Control group

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Effect of Autologous Plasma (ACP) on Surgical Repair of Rotator Cuff Tears

Further study details as provided by Schulthess Klinik:

Primary Outcome Measures:

Oxford Shoulder Score [ Time Frame: 3mo (6mo/24mo) ] [ Designated as safety issue: No ]
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:

VAS Pain [ Time Frame: 10d po ] [ Designated as safety issue: No ]
QuickDASH [ Time Frame: 3/6/24mo ] [ Designated as safety issue: No ]
EQ-5D [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]
ROM [ Time Frame: 3/6/24mo ] [ Designated as safety issue: No ]
Measurement of the abduction strength [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]
ASES Score [ Time Frame: 3/6/24mo ] [ Designated as safety issue: No ]
Constant Murley Score [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]
MRI/X-Ray/Ultrasonic Diagnostics [ Time Frame: 6/24 mo ] [ Designated as safety issue: No ]
Measurement of the external rotation strenght [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	December 2010
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: ACP Arthrex

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266226

Locations

Switzerland
Schulthess Klinik
Zürich, Canton Zürich, Switzerland, 8008

Sponsors and Collaborators

Schulthess Klinik

Arthrex, Inc.

Investigators

Principal Investigator:

Matthias Flury, Dr

Upper Extremities Department

More Information

No publications provided

Responsible Party:	Matthias Flury, Principal Investigator, Schulthess Klinik
ClinicalTrials.gov Identifier:	NCT01266226 History of Changes
Other Study ID Numbers:	ACP01, KEK-ZH-Nr. 2010-0309/4
Study First Received:	December 22, 2010
Last Updated:	March 1, 2013
Health Authority:	Switzerland: Swissmedic

Keywords provided by Schulthess Klinik:

Rotator cuff tears
ACP

Additional relevant MeSH terms:

Lacerations
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013