Platelet-Rich Plasma Therapy for Patellar Tendinopathy

NCT03136965 | Completed Phase 2 Results FDA Drug

• 4 other identifiers: 2016-0811A539300SMPH/RADIOLOGY/RADIOLOGY*Protocol Ver 0.15, 12/23/2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellar Tendinitis

Outcome Measures

Primary Outcomes (3)

• Change in Measure of Pain Level: VISA-P Score

  A quality of life measure, the Victoria Institute of Sport Assessment - Patellar Tendon (VISA-P) will be used to evaluate pain before and after the intervention. The instrument is scored from 0-100 with higher scores indicating less pain.

  baseline, 16 weeks, 32 weeks, 52 weeks

• Change in Measure of Activity Level: Tegner Activity Level Score

  The Tegner Activity Level Score will be used to evaluate activity level before and after the intervention. It is scored from 0-10 with 0 indicating disability and 10 competitive elite sport.

  baseline, 16 weeks, 32 weeks, 52 weeks

• Change in Visual Analogue Scale (VAS) Pain Score

  Participant pain level was assessed using a VAS score from 0 (no pain) to 10 (worst pain).

  baseline, 16 weeks, 32 weeks, 52 weeks

Secondary Outcomes (5)

• MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity)

  baseline, 16 weeks, 52 weeks

• MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)

  baseline, 16 weeks, 52 weeks

• Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)

  baseline, 16 weeks, 52 weeks

• Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline

  baseline, 16 weeks, 52 weeks

• Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline

  baseline, 16 weeks, 52 weeks

Other Outcomes (4)

• Isokinetic Dynamometer Measure of Flexor and Extensor Muscle Strength Before and After the Intervention

  baseline, 16 weeks, 52 weeks

• Relationship Between Changes in Novel Quantitative MRI and US Parameters of PT and Clinical and Biomechanical Improvement Following Treatment.

  52 weeks

• Ultrashort Time to Echo (UTE) T2* Relaxation Time (T2*Single)

  baseline, 16 weeks, 52 weeks

Study Arms (3)

Platelet-Rich Plasma (PRP)

EXPERIMENTAL

Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.

Biological: PRP

Dry Needling Procedure

PLACEBO COMPARATOR

Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.

Procedure: Dry Needling

Sham Procedure

SHAM COMPARATOR

Group 3 (sham) will undergo US-guided sham dry needling procedure.

Procedure: Dry Needling - Sham

Interventions

PRP BIOLOGICAL

Injection of autologous platelet rich plasma (PRP)

Platelet-Rich Plasma (PRP)

Dry Needling PROCEDURE

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.

Dry Needling Procedure

Dry Needling - Sham PROCEDURE

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.

Sham Procedure

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• General Electric: collaborator

Study Sites (1)

University of Wisconsin, Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Results Point of Contact

• Title: Kenneth Lee, MD, MBA
• Organization: University of Wisconsin School of Medicine and Public Health

klee2@uwhealth.org

(608) 263-9387

Study Officials

• Kenneth Lee, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded randomized controlled trial

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: May 2, 2017
• Study Start: April 25, 2017
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: October 26, 2023
• Results First Posted: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)