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

NCT ID: NCT03986372

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-20

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRP injection, once

PRP injection, once

Group Type EXPERIMENTAL

Platlet-rich plasma

Intervention Type BIOLOGICAL

Multiple Platlet-rich plasma injection.

PRP injection, twice

PRP injection, twice, 2 weeks apart

Group Type EXPERIMENTAL

Platlet-rich plasma

Intervention Type BIOLOGICAL

Multiple Platlet-rich plasma injection.

PRP injection, 3 times

PRP injection, 3 times, 2 weeks apart

Group Type EXPERIMENTAL

Platlet-rich plasma

Intervention Type BIOLOGICAL

Multiple Platlet-rich plasma injection.

Interventions

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Platlet-rich plasma

Multiple Platlet-rich plasma injection.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taoyuan Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chih-Kuan Wu, MD

Role: CONTACT

+886963039829

Facility Contacts

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Chih-Kuan Wu, MD

Role: primary

+886963039829

Other Identifiers

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201900117A3

Identifier Type: -

Identifier Source: org_study_id

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