NCT03986372

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 20, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 16, 2022

Status Verified

August 1, 2021

Enrollment Period

3.8 years

First QC Date

June 9, 2019

Last Update Submit

March 14, 2022

Conditions

Tendinopathy

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Correlation between Platlet derived growth factor (PDGF) and VISA-P score

    36 weeks

  • Correlation between Transforming growth factor beta 1 (TGF beta 1) and VISA-P score

    36 weeks

  • Correlation between Epithelial growth factor (EGF) and VISA-P score

    36 weeks

  • Change from baseline Victorian Institute of Sport Assessment (VISA) score to 104 weeks

    104 weeks

Study Arms (3)

PRP injection, once

EXPERIMENTAL

PRP injection, once

Biological: Platlet-rich plasma

PRP injection, twice

EXPERIMENTAL

PRP injection, twice, 2 weeks apart

Biological: Platlet-rich plasma

PRP injection, 3 times

EXPERIMENTAL

PRP injection, 3 times, 2 weeks apart

Biological: Platlet-rich plasma

Interventions

Platlet-rich plasmaBIOLOGICAL

Multiple Platlet-rich plasma injection.

PRP injection, 3 timesPRP injection, oncePRP injection, twice

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic patellar tendinopathy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taoyuan Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Central Study Contacts

Chih-Kuan Wu, MD

CONTACT

+886963039829xavierwu829@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2019

First Posted

June 14, 2019

Study Start

August 20, 2019

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

March 16, 2022

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)