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Completed

NCT Number: NCT01266226

Effect of 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schulthess Klinik

Zurich, Canton Zürich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous conditioned plasma

Device

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

Other names: ACP Arthrex

Control group

Device

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

Other names: ACP Arthrex

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Collaborators

  • Arthrex, Inc.

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Dec 24, 2010
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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