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Effect of ACP on Surgical Repair of Rotator Cuff Tears

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Arthrex, Inc.
Information provided by (Responsible Party):
Matthias Flury, Schulthess Klinik
ClinicalTrials.gov Identifier:
NCT01266226
First received: December 22, 2010
Last updated: November 17, 2014
Last verified: November 2014
  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: January 2015
Primary Completion Date: February 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 17, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Schulthess Klinik:
Rotator cuff tears
ACP

ClinicalTrials.gov processed this record on November 20, 2014