The Effect of Multiple Injection of Platlet-rich Plasma in Chronic Patellar Tendinopathy

According to previous studies, the effect of PRP to patellar tendinopathy could last longer. However, the type, concentration, time and frequent of injection are still debated。 This study is to understand the effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy and to analyze the relation between efficacy of PRP and the growth factor in PRP.

Study Overview

• Status: Recruiting
• Conditions: Tendinopathy
• Intervention / Treatment: Biological: Platlet-rich plasma

Detailed Description

Patellar tendinopathy, also known as jumper's knee，is clinically common characterised by anterior knee pain, activity-related pain、local tenderness over inferior pole of patella. The discomfort can result in decreasing athletic performance and be one of the most challenge for sports medicine doctor.

The patellar tendon suffer from repetitive microtrauma，result in reactive patellar tendinopathy. The overload tendon combining with risk factors of patellar tendinopathy will not recover timely and progress to chronic patellar tendinopathy. Hence, to reverse the progression is our aim.

According to previous studies, several nonsurgical treatment options have been proposed such as medication, eccentric exercise, corticosteroid injection, shockwave and platelet-rich plasma (PRP). Among all the options, the effect of PRP could last longer. However, the type, concentration, time and frequent of injection are still debated。Moreover, there is no study about the relationship between efficacy and the ratio and concentration of growth factor in the PRP.

The aim of this study is to understand (1) The effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy. (2) The effect of leukocyte-rich PRP in chronic patellar tendinopathy (3) Analyze the relation between efficacy of PRP and the growth factor in PRP.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Chih-Kuan Wu, MD; Phone Number: +886963039829; Email: xavierwu829@gmail.com

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Taoyuan Chang Gung Memorial Hospital
    • Contact: Chih-Kuan Wu, MD; Phone Number: +886963039829; Email: xavierwu829@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Chronic patellar tendinopathy

Exclusion Criteria:

1. Corticosteroid injections within 12 months
2. Previous knee surgery
3. Any confounding diagnosis to the knee joint
4. Arthritis
5. Rheumatoid arthritis
6. Diabetes
7. Infections of knee joint
8. NSAIDs in the 10 days before the procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PRP injection, once	Biological: Platlet-rich plasma; Multiple Platlet-rich plasma injection.
EXPERIMENTAL: PRP injection, twice; PRP injection, twice, 2 weeks apart	Biological: Platlet-rich plasma; Multiple Platlet-rich plasma injection.
EXPERIMENTAL: PRP injection, 3 times; PRP injection, 3 times, 2 weeks apart	Biological: Platlet-rich plasma; Multiple Platlet-rich plasma injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Victorian Institute of Sport Assessment (VISA-P) score to 36 weeks	Clinical evaluation for patellar tendinopathy minimum score: 0(worse outcome) maximum score: 100(better outcome)	36 weeks
Change from baseline modified Blazina Scale to 36 weeks	Clinical evaluation for patellar tendinopathy Stage 0 - No pain Stage 1 - Pain only after intense sports activity; no undue functional impairment Stage 2 - Pain at the beginning and after sports activity; still able to perform at a satisfactory level Stage 3 - Pain during sports activity; increasing difficulty in performing at a satisfactory level Stage 4 - Pain during sports activity; unable to participate in sport at a satisfactory level Stage 5 - Pain during daily activity; unable to participate in sport at any level	36 weeks
Change from baseline thickness of patellar tendon to 36 weeks	Sonographic evaluation for patellar tendinopathy to measure the thickness of proximal patellar tendon.	36 weeks
Change from baseline Visual analogue score(VAS) to 36 weeks	evaluation for pain(minimal score:0, maximal score:10)	36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between Platlet derived growth factor (PDGF) and VISA-P score	Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(PDGF)	36 weeks
Correlation between Transforming growth factor beta 1 (TGF beta 1) and VISA-P score	Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(TGF beta 1)	36 weeks
Correlation between Epithelial growth factor (EGF) and VISA-P score	Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(EGF)	36 weeks
Change from baseline Victorian Institute of Sport Assessment (VISA) score to 104 weeks	To evaluate the longterm effect of multiple PRP injection	104 weeks

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2019
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: June 9, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (ACTUAL): June 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: 201900117A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No