Effect of ACP on Surgical Repair of Rotator Cuff Tears

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01266226
• Other study ID #: ACP01
• Secondary ID: KEK-ZH-Nr. 2010-
• Status: Completed
• Phase: N/A
• First received: December 22, 2010
• Last updated: May 19, 2015
• Start date: December 2010
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: February 2015
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Tears

Intervention

Device:
• Autologous conditioned plasma
4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.
• Control group
4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.

Locations

Country	Name	City	State
Switzerland	Schulthess Klinik	Zürich	Canton Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Schulthess Klinik	Arthrex, Inc.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	VAS Pain		10d po	No
Secondary	QuickDASH		3/6/24mo	No
Secondary	EQ-5D		3/6/24 mo	No
Secondary	ROM		3/6/24mo	No
Secondary	Measurement of the abduction strength		3/6/24 mo	No
Secondary	ASES Score		3/6/24mo	No
Secondary	Constant Murley Score		3/6/24 mo	No
Secondary	MRI/X-Ray/Ultrasonic Diagnostics		6/24 mo	No
Secondary	Measurement of the external rotation strenght		3/6/24 mo	No