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: October 7, 2013
Last verified: October 2013

December 22, 2010
October 7, 2013
December 2010
February 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01266226 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 strenght [ 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 ]
Not Provided
Not Provided
 
Effect of ACP on Surgical Repair of Rotator Cuff Tears
Effect of Autologous Plasma (ACP) on Surgical Repair of Rotator Cuff Tears

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Rotator Cuff Tears
  • Device: Autologous conditioned plasma
    4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.
    Other Name: ACP Arthrex
  • Device: Control group
    4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.
    Other Name: ACP Arthrex
  • 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.
    Intervention: Device: Autologous conditioned plasma
  • 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.
    Intervention: Device: Control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
January 2015
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01266226
ACP01, KEK-ZH-Nr. 2010-0309/4
Yes
Matthias Flury, Schulthess Klinik
Schulthess Klinik
Arthrex, Inc.
Principal Investigator: Matthias Flury, Dr Upper Extremities Department
Schulthess Klinik
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP