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

Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03986372
• Other study ID #: 201900117A3
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 20, 2019
• Est. completion date: June 2023

Study information

• Verified date: August 2021
• Source: Chang Gung Memorial Hospital
• Contact: Chih-Kuan Wu, MD
• Phone: +886963039829
• Email: xavierwu829[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tendinopathy

Intervention

Biological:
• Platlet-rich plasma
Multiple Platlet-rich plasma injection.

Locations

Country	Name	City	State
Taiwan	Taoyuan Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Change from baseline Visual analogue score(VAS) to 36 weeks	evaluation for pain(minimal score:0, maximal score:10)	36 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline Victorian Institute of Sport Assessment (VISA) score to 104 weeks	To evaluate the longterm effect of multiple PRP injection	104 weeks