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

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ClinicalTrials.gov Identifier: NCT03986372
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Tendinopathy Biological: Platlet-rich plasma Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Multiple Injection of Platlet-rich Plasma in Chronic Patellar Tendinopathy
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Experimental: PRP injection, once
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.




Primary Outcome Measures :
  1. Change from baseline Victorian Institute of Sport Assessment (VISA-P) score to 36 weeks [ Time Frame: 36 weeks ]
    Clinical evaluation for patellar tendinopathy minimum score: 0(worse outcome) maximum score: 100(better outcome)

  2. Change from baseline modified Blazina Scale to 36 weeks [ Time Frame: 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

  3. Change from baseline thickness of patellar tendon to 36 weeks [ Time Frame: 36 weeks ]
    Sonographic evaluation for patellar tendinopathy to measure the thickness of proximal patellar tendon.

  4. Change from baseline Visual analogue score(VAS) to 36 weeks [ Time Frame: 36 weeks ]
    evaluation for pain(minimal score:0, maximal score:10)


Secondary Outcome Measures :
  1. Correlation between Platlet derived growth factor (PDGF) and VISA-P score [ Time Frame: 36 weeks ]
    Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(PDGF)

  2. Correlation between Transforming growth factor beta 1 (TGF beta 1) and VISA-P score [ Time Frame: 36 weeks ]
    Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(TGF beta 1)

  3. Correlation between Epithelial growth factor (EGF) and VISA-P score [ Time Frame: 36 weeks ]
    Aim: To find the relationship between treatment effect(VISA-P score) and concentration of growth factor(EGF)

  4. Change from baseline Victorian Institute of Sport Assessment (VISA) score to 104 weeks [ Time Frame: 104 weeks ]
    To evaluate the longterm effect of multiple PRP injection



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986372


Contacts
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Contact: Chih-Kuan Wu +886963039829 xavierwu829@gmail.com

Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Chih-Kuan Wu Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03986372     History of Changes
Other Study ID Numbers: 201900117A3
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries