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NCT04350827

PRP vs PRP Plus IGF for Patellar Tendinosis

Completed NA Results posted Last updated 30 October 2023
What this trial tests

NA trial testing Platelet Rich Plasma in Tendinopathy in 14 participants. Completed in 16 October 2021.

Timeline
25 February 2020
Primary endpoint
16 October 2021
16 October 2021

Quick facts

Lead sponsorOhio State University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment14
Start date25 February 2020
Primary completion16 October 2021
Estimated completion16 October 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Ohio State University

Who can join

18 and older, any sex, with Tendinopathy or Patellar Ligament. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Victorian Institute of Sport Assessment-patellar Tendon (VISA-P) Primary · 6 months

Victorian Institute of sport assessment scale for patellar tendinopathy \[VISA-P\] is a self-administered questionnaire consisting of 8 items; 6 are used to evaluate pain levels or disability in daily activities and specific functional tests and 2 provide information regarding ability to play sport. The maximum score possible is 100 points and represents an asymptomatic athlete who can fully engage in sports. The theoretical minimum is 0 points.

GroupValue95% CI
Platelet Rich Plasma66.4± 17.8
Platelet Rich Plasma Plus IGF78.2± 15.3
Visual Analog Scale-Pain Secondary · 6 months

The Visual Analog Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

GroupValue95% CI
Platelet Rich Plasma2.38± 2.82
Platelet Rich Plasma Plus IGF1.30± 2.07
Tegner Activity Scale Secondary · 6 months

The Tegner activity scale is a one-item score that grads activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 athlete participating in competitive sports.

GroupValue95% CI
Platelet Rich Plasma5.8± 1.9
Platelet Rich Plasma Plus IGF6.5± 0.8
Blazina Classification Secondary · 6 months

Classification scale for functional limitations associated with patellar tendinitis. Stage 1: Pain after sports activity, Stage 2: Pain at the beginning of sports activity, disappearing with warm-up and sometimes reappearing with fatigue, Stage 3: Pain at rest and during activity; inability to participate in sports, Stage 4: Rupture of the patellar tendon

GroupValue95% CI
Platelet Rich Plasma4
Platelet Rich Plasma Plus IGF5
Platelet Rich Plasma0
Platelet Rich Plasma Plus IGF1
Platelet Rich Plasma1
Platelet Rich Plasma Plus IGF0
Platelet Rich Plasma0
Platelet Rich Plasma Plus IGF0

Sponsor's own description

The purpose of this study is to compare two different platelet-rich plasma (PRP) injections for patellar tendinosis. Aim: To perform a randomized, double blinded study comparing the clinical effect of PRP versus PRP + concentrated insulin-like growth factor (IGF) in patients with patellar tendinosis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Platelet Rich Plasma

Trials testing the same drug.

Other recruiting trials for Tendinopathy

Currently open trials in the same condition.

Other Ohio State University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04350827.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing