N/A
N=14
PRP vs PRP Plus IGF for Patellar Tendinosis
Tendinopathy · Patellar Ligament · Platelet-Rich Plasma
Bottom Line
View on ClinicalTrials.gov: NCT04350827 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Victorian Institute of Sport Assessment-patellar Tendon (VISA-P) — 66.4; 78.2 units on a scale — p=0.433
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Platelet Rich Plasma (Device); Platelet Rich Plasma plus IGF (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Victorian Institute of Sport Assessment-patellar Tendon (VISA-P) |
66.4; 78.2 | 0.433 |
| SECONDARY Visual Analog Scale-Pain |
2.38; 1.30 | — |
| SECONDARY Tegner Activity Scale |
5.8; 6.5 | — |
| SECONDARY Blazina Classification |
4; 5; 0; 1; 1; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- >6 weeks of symptomatic patellar tendinosis
- unilateral or bilateral
- 18 yrs of age or older
- active in sport and exercise at least 3x / week
- able to take time away from sport (for healing and rehabilitation phase after procedure)
- failed at least 6 weeks of guided rehabilitation (under the supervision of either a certified athletic trainer or physical therapist)
- minimum Tegner activity level of 4
Exclusion Criteria
- Steroid injection in target knee in the last 3 months
- PRP in the target knee in the last 6 months
- No other cellular treatments in index knee (bone marrow, amniotic suspensions) last 1 year
- Participation in any experimental device or drug study within 1 year before screening visit
- Oral or IM steroids for last 3 months
- Dry needling of patellar tendon in last 6 months
Data sourced from ClinicalTrials.gov (NCT04350827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.