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Platelet-Rich Plasma Therapy for Patellar Tendinopathy (PRP)

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ClinicalTrials.gov Identifier: NCT03136965
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : July 16, 2021
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The overall goal of this research is to find an effective treatment for patellar tendinopathy (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function scores) and bio-mechanical (knee strength) measures will be correlated with disease modification changes assessed using conventional and novel quantitative magnetic resonance imaging (MRI) and ultrasound (US) techniques.

Condition or disease Intervention/treatment Phase
Patellar Tendinitis Biological: PRP Procedure: Dry Needling Procedure: Dry Needling - Sham Phase 2

Detailed Description:
Sixty-six patients with PT will be randomized to one of three study arms. Subjects in Group 1 (PRP) will receive a single US-guided injection of 5 milliliters of autologous PRP into the patellar tendon, subjects in Group 2 (DN) will undergo ultrasound guided dry needling of the patellar tendon, and subjects in Group 3 (SH) will undergo a sham control ultrasound guided dry needling in the subcutaneous tissue only (not intratendon) at the level of the patellar tendon. The efficacy of the different treatment options will be assessed by pain- and function-dependent, PT-specific Victorian Institute of Sport Assessment Patella (VISA-P) quality of life scores, activity level scores, knee strength measurements, and conventional and novel MRI and US imaging at baseline, 16, 32, and 52 weeks post-treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blinded randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Subjects and assessors will be blinded to the subject group allocation. Subjects will be identified to study personnel using a unique study number only and results of the imaging studies will be blinded, batched, and evaluated in a randomized manner.
Primary Purpose: Treatment
Official Title: Platelet-Rich Plasma (PRP) Therapy for Patellar Tendinopathy: A Randomized Controlled Trial Correlating Clinical, Biomechanical and Novel Imaging Biomarkers
Actual Study Start Date : April 25, 2017
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Experimental: Platelet-Rich Plasma (PRP)
Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
Biological: PRP
Injection of autologous platelet rich plasma (PRP)

Placebo Comparator: Dry Needling Procedure
Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Procedure: Dry Needling
This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.

Sham Comparator: Sham Procedure
Group 3 (sham) will undergo US-guided sham dry needling procedure.
Procedure: Dry Needling - Sham
This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.




Primary Outcome Measures :
  1. Measure of pain level [ Time Frame: 52 weeks ]
    A quality of life measure, the VISA-P will be used to evaluate pain before and after the intervention.

  2. Measure of activity level [ Time Frame: 52 weeks ]
    A quality of life measure, the VISA-P will be used to evaluate activity level before and after the intervention.


Secondary Outcome Measures :
  1. MRI Scan To demonstrate treatment-related changes in pathologic imaging features of PT (thickness and T2 signal intensity). [ Time Frame: 52 weeks ]
    To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.

  2. Ultrasound Scan to demonstrate treatment-related changes in pathologic imaging features of PT (thickness, echogenicity, and hyperemia) [ Time Frame: 52 weeks ]
    To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures.

  3. Isokinetic Dynamometer measure of flexor and extensor muscle strength before and after the intervention [ Time Frame: 52 weeks ]
    Flexor and extensor muscle strength will be measured with this device before and after the intervention.


Other Outcome Measures:
  1. Relationship between changes in novel quantitative MRI and US parameters of PT and clinical and biomechanical improvement following treatment. [ Time Frame: 52 weeks ]
    To investigate the relationship between changes in novel quantitative MRI techniques and US parameters of PT and clinical and biomechanical improvement following treatment.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18 and 39 years
  2. Chronic (>3 months) PT
  3. Clinical examination consistent with PT
  4. MRI or US confirmation of PT
  5. Pain score of 3 or greater on a 10-point visual analogue scale
  6. Self-report failure of supervised physical therapy
  7. Self-report failure of at least 2 of the most common treatment options for PT (e.g. NSAIDs, relative rest, ice and bracing).

Exclusion Criteria:

  1. Inability to comply with study follow-up requirements
  2. History of bleeding disorders or other hematologic conditions
  3. Knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal tear, ligament injury or reconstruction)
  4. Full or partial patellar tendon tear
  5. Current use of anticoagulation or immunosuppressive therapy
  6. Prior knee trauma requiring medical attention or surgery
  7. Worker's compensation injury
  8. Daily opioid use for pain
  9. Contraindication to MRI.
  10. Systemic diseases such as Diabetes and connective tissue diseases.
  11. Prior PRP or DN procedure.
  12. Women that are pregnant

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): NCT03136965


Contacts
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Contact: Gemma Gliori, MS 608-262-7269 ggliori@uwhealth.org
Contact: Suzanne Hanson, BS 608.263.7421 shanson@uwhealth.org

Locations
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United States, Wisconsin
University of Wisconsin, Madison Recruiting
Madison, Wisconsin, United States, 53705
Principal Investigator: Kenneth Lee, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
General Electric
Investigators
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Principal Investigator: Kenneth Lee, MD University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03136965    
Other Study ID Numbers: 2016-0811
A539300 ( Other Identifier: UW Madison )
SMPH/RADIOLOGY/RADIOLOGY* ( Other Identifier: UW Madison )
Protocol Ver 0.14, 7/29/2020 ( Other Identifier: UW Madison )
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries