Effect of ACP on Surgical Repair of Rotator Cuff Tears

NCT ID: NCT01266226

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-02-28

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.

Conditions

Rotator Cuff Tears

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Autologous conditioned plasma

Intervention Type: DEVICE

4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.

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.

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: DEVICE

4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.

Interventions

Autologous conditioned plasma

4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.

Intervention Type: DEVICE

Control group

4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.

Intervention Type: DEVICE

Other Intervention Names

ACP Arthrex; ACP Arthrex

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthrex, Inc.

INDUSTRY

Sponsor Role: collaborator

Schulthess Klinik

OTHER

Sponsor Role: lead

Responsible Party

Matthias Flury

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthias Flury, Dr

Role: PRINCIPAL_INVESTIGATOR

Upper Extremities Department

Locations

Schulthess Klinik

Zurich, Canton Zürich, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 27184542 (View on PubMed)

Other Identifiers

KEK-ZH-Nr. 2010-0309/4

Identifier Type: OTHER

Identifier Source: secondary_id

ACP01

Identifier Type: -

Identifier Source: org_study_id