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Effect of ACP on Surgical Repair of Rotator Cuff Tears

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ClinicalTrials.gov Identifier: NCT01266226
Recruitment Status : Completed
First Posted : December 24, 2010
Last Update Posted : May 20, 2015
Sponsor:
Collaborator:
Arthrex, Inc.
Information provided by (Responsible Party):
Matthias Flury, Schulthess Klinik

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tears Device: Autologous conditioned plasma Device: Control group Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Autologous Plasma (ACP) on Surgical Repair of Rotator Cuff Tears
Study Start Date : December 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Oxford Shoulder Score [ Time Frame: 3mo (6mo/24mo) ]
    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 :
  1. VAS Pain [ Time Frame: 10d po ]
  2. QuickDASH [ Time Frame: 3/6/24mo ]
  3. EQ-5D [ Time Frame: 3/6/24 mo ]
  4. ROM [ Time Frame: 3/6/24mo ]
  5. Measurement of the abduction strength [ Time Frame: 3/6/24 mo ]
  6. ASES Score [ Time Frame: 3/6/24mo ]
  7. Constant Murley Score [ Time Frame: 3/6/24 mo ]
  8. MRI/X-Ray/Ultrasonic Diagnostics [ Time Frame: 6/24 mo ]
  9. Measurement of the external rotation strenght [ Time Frame: 3/6/24 mo ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 ( Other Identifier: Regional Ethics Committee of Zurich )
First Posted: December 24, 2010    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by Matthias Flury, Schulthess Klinik:
Rotator cuff tears
ACP

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries