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Platelet-Rich Plasma (PRP) Injection for the Treatment of Chronic Patellar Tendinopathy (PRP)

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ClinicalTrials.gov Identifier: NCT01843504
Recruitment Status : Enrolling by invitation
First Posted : April 30, 2013
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The goal of this study is to find an effective treatment for chronic patellar tendinopathy (PT). Investigators will conduct a 32-week randomized controlled clinical trial to determine whether platelet rich plasma (PRP) injections improve disease-specific clinical outcomes with correlation to a new method of ultrasound (US) imaging assessment called Acoustoelastography (AE). Positive findings of PRP compared to control would suggest future larger scale studies to help establish an optimal protocol for the nonsurgical management of PT.

Condition or disease Intervention/treatment Phase
Chronic Patellar Tendinopathy Chronic PT Biological: platelet rich plasma Other: saline Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Clinical, Biomechanical, and Tissue Regenerating Effects of a Single Platelet-rich Plasma Injection for the Treatment of Chronic Patellar Tendinopathy: a Randomized Controlled Trial
Study Start Date : March 2013
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Active Comparator: Platelet Rich Plasma
Subjects in Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous platelet-rich plasma at week 0 (baseline).
Biological: platelet rich plasma
A blood draw of 15 mL of the subject's own blood will be performed. The study coordinator will then place the sample in the Platelet Separator System (a centrifuge) and spin the blood sample in using a two-stage spinning: the 1st separates red blood cells from platelets, and the 2nd concentrates the platelets. This will be spun by centrifuge to yield 6 mL of concentrated autologous platelet. Under continuous ultrasound evaluation, 1.0-2.0 mL of the prepared PRP will be injected onto the origin of the patella tendon itself will be peppered along a short segment of the tendon into the areas of palpated tenderness and US-documented pathology.

Placebo Comparator: Group 2
Subjects in Group 2 (saline control) will receive a single injection of 5 mL 0.9% normal saline at week 0.
Other: saline
A blood draw of 15 mL of the subject's own blood will be performed to maintain blinding. Under continuous ultrasound evaluation, 1.0-2.0 mL of the saline solution will be injected onto the origin of the patella tendon itself will be peppered along a short segment of the tendon into the areas of palpated tenderness and US-documented pathology.




Primary Outcome Measures :
  1. Outcome questionnaire score evaluation [ Time Frame: One year ]
    Subjects will complete outcome questionnaires at weeks 0, 4, 8, 12, 16, and 32 weeks. The results will report evaluate improved pain- and function-dependent, knee-specific quality of life, as assessed by composite scores on the validated Victorian Institute of Sport Assessment-Patellar (VISAP), International Knee Documentation Committee (IKDC), and knee injection questionnaires. The results of the Groups 1 and 2 will be compared.


Secondary Outcome Measures :
  1. Ultrasound evaluation of changes of pathologic features [ Time Frame: One year ]
    Ultrasound (US) changes of several pathologic features of PT will be evaluated using US imaging of the patellar tendon at 32 weeks compared to baseline imaging. Conventional ultrasound will be done to assess thickness (contralateral comparison), neovascularity, and hypoechogenicity; and Acoustoelastography (AE) will be done to measure stiffness changes of the patellar tendon using standardized 0-3 severity scales compared to control subjects.


Other Outcome Measures:
  1. Evaluation of subject satisfaction of PRP therapy [ Time Frame: One year ]
    Outcome measures will be compared for satisfaction with PRP therapy as assessed by the treatment satisfaction survey score at 32 weeks post-treatment.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. age18-65
  2. chronic (>3months) patellar tendon pain;
  3. clinical exam findings consistent with PT;
  4. self-reported failure of supervised physical therapy;
  5. self-reported failure of at least 2 of the most common treatments (NSAIDs, relative rest, ice, bracing) for patellar tendinopathy.

Exclusion Criteria:

  1. inability to comply with follow-up requirements of study,
  2. history of bleeding disorders, low-platelet counts, other hematologic conditions;
  3. knee pain due to another possible etiology(e.g., degenerative joint disease);
  4. current or recent use of anticoagulation or immunosuppressive therapy;
  5. known allergy to acetaminophen or Lidocaine;
  6. self-reported pregnancy;
  7. worker's compensation injury;
  8. pending litigation;
  9. concurrent opioid use for pain

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): NCT01843504


Locations
United States, Wisconsin
Wisconsin Institute of Medical Research
Madison, Wisconsin, United States, 53705
UW Sports Medicine Clinic at Research Park
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: John J. Wilson, MD, MS UW-Madison School of Medicine & Public Health
Principal Investigator: Stephen J. Almasi, MD UW-Madison School of Medicine & Public Health
Principal Investigator: Kenneth S. Lee, MD UW-Madison School of Medicine & Public Health

Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01843504     History of Changes
Other Study ID Numbers: 2018-0177
2012-0723 ( Other Identifier: UW IRB )
First Posted: April 30, 2013    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

Keywords provided by University of Wisconsin, Madison:
platelet rich plasma
PRP
plasma
plasma injection
patellar tendinopathy
patella tendon
patella
ultrasound
shear wave ultrasound
tendinosis
tendinopathy
tendinitis
jumper's knee

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries