Research

Randomized Controlled Trial of Platelet-Rich Plasma Versus Whole Blood in the Treatment of Chronic Mid-Portion Achilles Tendinosis

IRB Number: 11066

Institutional Review Board, Hospital for Special Surgery

October 20, 2011

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Principal Investigator

John G. Kennedy, MD

Co-Investigators

Christopher D. Murawski
Ashraf M. Fansa
Eric Bogner, MD

Summary

Multi-center clinical trial including 30 patients at HSS and 30 at University of Pittsburgh.  6 month follow-up required.  Patients randomized to two groups, PRP and whole blood (control).

Inclusion/Exclusion Criteria

Inclusio Criteria:

1) All patients must have clinical suspicion followed by radiographic (MRI) confirmation of chronic mid-portion Achilles tendinosis to be suitable for the present study.  For the present study, “chronic” will be defined as having symptoms for greater than or equal to three months.  A PubMed literature search has not revealed a standard definition of “chronic” in the treatment of Achilles tendinosis.  However, in Dr. Kennedy’s experience, 3 months is the point in time when initial treatment is considered a failure.  Thus, the investigators’ will use this time point for the present study.  Failure will be determined clinically insofar as no improvement in patient symptoms from conservative treatment strategies. Note that in the  recent JAMA study (12), the term “chronic” was used to identify the symptoms but never defined in terms of a specific time point. 
 2) Only mild to moderate mid-portion Achilles tendinosis will be included in the present  study.  Mild to moderate tendinosis will be defined using MRI.
 3) Patients 18 years old and greater and under the age of 70 years
 4) All patients must undergo the procedure utilizing the Ateriocyte Magellan PRP  system. 
 5) Patients must refrain from taking aspirin or other medications that alter platelet  function within 3 days prior to undergoing a PRP injection. 

Exclusion Criteria: 

1) Radiographic (MRI) confirmation of an Achilles tendon rupture
2) Radiographic (MRI) confirmation of any and all insertional pathology (mild-severe) of the Achilles tendon in addition to any and all grades of retrocalcaneal bursitis will be excluded.
3) Any patient having symptoms of Achilles tendinosis for less than 3 months. 
4) Any patient identified as having severe mid-portion Achilles tendinosis. 
5) Patients seeking treatment for any other injury in addition to Achilles tendinosis and patients who have already received ANY prior treatment for this injury will be excluded to control confounding variables.
6) Patients with identified with Rheumatoid Arthritis and/or Diabetes
7) If any patient has the known presence of a pregnancy.
8) Patients over the age of 70 years.
9) Patients under the age of 18 years.
10) Patients undergoing a PRP procedure while utilizing any other system than the Ateriocyte Magellan PRP system.  
11) Any patient currently on any form of blood thinner.
12) Any patient being identified as a professional athlete (greater than or equal to 14 hours of training per week for the respective sport)
13) PRP use is contraindicated for patients with disorders associated with platelet dysfunction and who have laboratory evidence of septicemia.

Contact Information

Christopher Murawski
646.797.8880
MurawskiC@HSS.EDU

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