NCT03136965

Platelet-Rich Plasma Therapy for Patellar Tendinopathy

Platelet-Rich Plasma (PRP) Therapy for Patellar Tendinopathy: A Randomized Controlled Trial Correlating Clinical, Biomechanical and Novel Imaging Biomarkers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patellar Tendinitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-04-25
• Primary completion: 2022-08-15
• Completion: 2022-08-15
• First posted: 2017-05-02
• Last updated: 2023-10-26
• Results posted: 2023-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study