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

Primary Purpose

Tendinopathy

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Platlet-rich plasma
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taoyuan Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

PRP injection, once

PRP injection, twice

PRP injection, 3 times

Arm Description

PRP injection, once

PRP injection, twice, 2 weeks apart

PRP injection, 3 times, 2 weeks apart

Outcomes

Primary Outcome Measures

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)
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
Change from baseline thickness of patellar tendon to 36 weeks
Sonographic evaluation for patellar tendinopathy to measure the thickness of proximal patellar tendon.
Change from baseline Visual analogue score(VAS) to 36 weeks
evaluation for pain(minimal score:0, maximal score:10)

Secondary Outcome Measures

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)
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)
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)
Change from baseline Victorian Institute of Sport Assessment (VISA) score to 104 weeks
To evaluate the longterm effect of multiple PRP injection

Full Information

First Posted
June 9, 2019
Last Updated
March 14, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03986372
Brief Title
The Effect of Multiple Injection of Platlet-rich Plasma in Chronic Patellar Tendinopathy
Official Title
The Effect of Multiple Injection of Platlet-rich Plasma in Chronic Patellar Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRP injection, once
Arm Type
Experimental
Arm Description
PRP injection, once
Arm Title
PRP injection, twice
Arm Type
Experimental
Arm Description
PRP injection, twice, 2 weeks apart
Arm Title
PRP injection, 3 times
Arm Type
Experimental
Arm Description
PRP injection, 3 times, 2 weeks apart
Intervention Type
Biological
Intervention Name(s)
Platlet-rich plasma
Intervention Description
Multiple Platlet-rich plasma injection.
Primary Outcome Measure Information:
Title
Change from baseline Victorian Institute of Sport Assessment (VISA-P) score to 36 weeks
Description
Clinical evaluation for patellar tendinopathy minimum score: 0(worse outcome) maximum score: 100(better outcome)
Time Frame
36 weeks
Title
Change from baseline modified Blazina Scale to 36 weeks
Description
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
Time Frame
36 weeks
Title
Change from baseline thickness of patellar tendon to 36 weeks
Description
Sonographic evaluation for patellar tendinopathy to measure the thickness of proximal patellar tendon.
Time Frame
36 weeks
Title
Change from baseline Visual analogue score(VAS) to 36 weeks
Description
evaluation for pain(minimal score:0, maximal score:10)
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Correlation between Platlet derived growth factor (PDGF) and VISA-P score
Description
Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(PDGF)
Time Frame
36 weeks
Title
Correlation between Transforming growth factor beta 1 (TGF beta 1) and VISA-P score
Description
Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(TGF beta 1)
Time Frame
36 weeks
Title
Correlation between Epithelial growth factor (EGF) and VISA-P score
Description
Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(EGF)
Time Frame
36 weeks
Title
Change from baseline Victorian Institute of Sport Assessment (VISA) score to 104 weeks
Description
To evaluate the longterm effect of multiple PRP injection
Time Frame
104 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic patellar tendinopathy Exclusion Criteria: Corticosteroid injections within 12 months Previous knee surgery Any confounding diagnosis to the knee joint Arthritis Rheumatoid arthritis Diabetes Infections of knee joint NSAIDs in the 10 days before the procedure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chih-Kuan Wu, MD
Phone
+886963039829
Email
xavierwu829@gmail.com
Facility Information:
Facility Name
Taoyuan Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Kuan Wu, MD
Phone
+886963039829
Email
xavierwu829@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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