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.
Group
Value
95% CI
Platelet Rich Plasma
66.4
± 17.8
Platelet Rich Plasma Plus IGF
78.2
± 15.3
Visual Analog Scale-PainSecondary· 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').
Group
Value
95% CI
Platelet Rich Plasma
2.38
± 2.82
Platelet Rich Plasma Plus IGF
1.30
± 2.07
Tegner Activity ScaleSecondary· 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.
Group
Value
95% CI
Platelet Rich Plasma
5.8
± 1.9
Platelet Rich Plasma Plus IGF
6.5
± 0.8
Blazina ClassificationSecondary· 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
Group
Value
95% CI
Platelet Rich Plasma
4
Platelet Rich Plasma Plus IGF
5
Platelet Rich Plasma
0
Platelet Rich Plasma Plus IGF
1
Platelet Rich Plasma
1
Platelet Rich Plasma Plus IGF
0
Platelet Rich Plasma
0
Platelet Rich Plasma Plus IGF
0
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.
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Trials by the same sponsor.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ohio State University
Last refreshed: 30 October 2023
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.