Clinical trial NCT01266226: Effect of ACP on Surgical Repair of Rotator Cuff Tears
Official title: Effect of Autologous Plasma (ACP) on Surgical Repair of Rotator Cuff Tears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: Rotator cuff tears
ACP
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2010-12-24
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Oxford Shoulder Score
timeFrame: 3mo (6mo/24mo)
Secondary outcomes:
measure: VAS Pain
timeFrame: 10d po
measure: QuickDASH
timeFrame: 3/6/24mo
measure: EQ-5D
timeFrame: 3/6/24 mo
measure: ROM
timeFrame: 3/6/24mo
measure: Measurement of the abduction strength
timeFrame: 3/6/24 mo
measure: ASES Score
timeFrame: 3/6/24mo
measure: Constant Murley Score
timeFrame: 3/6/24 mo
measure: MRI/X-Ray/Ultrasonic Diagnostics
timeFrame: 6/24 mo
measure: Measurement of the external rotation strenght
timeFrame: 3/6/24 mo
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
state: Canton Zürich
Study officials:
affiliation: Upper Extremities Department
name: Matthias Flury, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.