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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

Tracking Information
First Submitted Date  ICMJE April 6, 2017
First Posted Date  ICMJE May 2, 2017
Last Update Posted Date July 16, 2021
Actual Study Start Date  ICMJE April 25, 2017
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 26, 2017)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Platelet-Rich Plasma Therapy for Patellar Tendinopathy
Official Title  ICMJE Platelet-Rich Plasma (PRP) Therapy for Patellar Tendinopathy: A Randomized Controlled Trial Correlating Clinical, Biomechanical and Novel Imaging Biomarkers
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Patellar Tendinitis
Intervention  ICMJE
  • Biological: PRP
    Injection of autologous platelet rich plasma (PRP)
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Platelet-Rich Plasma (PRP)
    Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
    Intervention: Biological: PRP
  • Placebo Comparator: Dry Needling Procedure
    Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
    Intervention: Procedure: Dry Needling
  • Sham Comparator: Sham Procedure
    Group 3 (sham) will undergo US-guided sham dry needling procedure.
    Intervention: Procedure: Dry Needling - Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2020)
76
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2017)
66
Estimated Study Completion Date  ICMJE August 31, 2023
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gemma Gliori, MS 608-262-7269 ggliori@uwhealth.org
Contact: Suzanne Hanson, BS 608.263.7421 shanson@uwhealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03136965
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE General Electric
Investigators  ICMJE
Principal Investigator: Kenneth Lee, MD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date July 2021

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