- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04350827
PRP vs PRP Plus IGF for Patellar Tendinosis
Platelet-rich Plasma Versus Platelet-rich Plasma Plus Concentrated Insulin-like Growth Factor for Patellar Tendinosis: a Randomized Comparative Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction/Background:
Patellar tendinosis is a frustrating ailment commonly encountered in sports medicine. Treating this condition continues to be a significant challenge for sports medicine physicians. The tendinosis lesion is characterized by collagen disorganization and increased ground substance. One method of treating this problem is using platelet rich plasma (PRP), which is a concentration of platelets from the patient's own blood that provides a high dose of growth factors aimed at stimulating tendon healing. These injections have been used extensively to treat many tendon disorders including patellar tendinosis. Several studies have demonstrated the safety and efficacy of using PRP to treat patellar tendinosis.
One growth factor that is known to be helpful in tendon healing is insulin-like growth factor (IGF). However, IGF is not found in PRP but rather in the free plasma that is spun off during the PRP processing. This free plasma or platelet poor plasma (PPP) is typically discarded but it is a known source of IGF. We have shown that concentrating PPP in the FDA cleared Plasmax device yields an increased concentration of insulin-like growth factor (IGF). Local IGF injections into the patellar tendon have demonstrated improved tendon healing, but the effect on clinical outcomes has never been studied in a controlled fashion.
Research Design: Double blinded randomized comparative trial.
Detailed Study Procedures: 38 patients will be randomly assigned to a treatment arm. 19 patients will receive platelet rich plasma (PRP) and 19 patients will receive PRP plus concentrated IGF. Patient will be blinded to their treatment, but treatment team will not. PRP will be prepared according to standard sterile procedures out of view of the patient to ensure patients are adequately blinded. The injecting physician will not be blinded to randomization scheme.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43221
- The Ohio State University Sports Medicine Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Platelet Rich Plasma
Procedure will be carried out with excellent sterile technique.
54ml of whole blood will be drawn.
54ml will be processed by centrifugation using the GPS III system (Zimmer Biomet, Warsaw, IN) and 1 ml will undergo a complete blood count (for a baseline comparison to determine the fold increase in platelets).
The resultant PRP (5ml) will be injected (after 5ml 1% lidocaine has been injected into the skin for comfort) into the patellar tendon using ultrasound guidance to accurately direct the injection to the site of the tendon abnormality.
The patient will rest after the injection for 15 minutes and then be dismissed.
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Platelet rich plasma injection into patellar tendon
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Active Comparator: Platelet Rich Plasma plus IGF
The PRP preparation and blood draw will be identical to the above.
55ml of whole blood will be drawn (1ml will undergo a CBC and the remaining 54ml will be used to make PRP).
In addition to preparing the PRP, the resultant PPP (instead of discarding it) will be placed into the Plasmax device (Zimmer Biomet, Warsaw, IN) and concentrated via a second centrifugation cycle.
The plasmax concentrate (concentrated IGF) will be added to the PRP (3ml of PRP + 2ml of plasmax concentrate for a total of 5ml) and then will be injected (after 5ml 1% lidocaine has been injected into the skin for comfort) under ultrasound guidance followed by the same rest period.
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Platelet rich plasma plus IGF injection into patellar tendon
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Victorian Institute of Sport Assessment-patellar Tendon (VISA-P)
Time Frame: 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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale-Pain
Time Frame: 6 months
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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').
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6 months
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Tegner Activity Scale
Time Frame: 6 months
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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.
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6 months
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Blazina Classification
Time Frame: 6 months
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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
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6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Baria, MD, Ohio State University
Publications and helpful links
General Publications
- Andriolo L, Altamura SA, Reale D, Candrian C, Zaffagnini S, Filardo G. Nonsurgical Treatments of Patellar Tendinopathy: Multiple Injections of Platelet-Rich Plasma Are a Suitable Option: A Systematic Review and Meta-analysis. Am J Sports Med. 2019 Mar;47(4):1001-1018. doi: 10.1177/0363546518759674. Epub 2018 Mar 30.
- Charousset C, Zaoui A, Bellaiche L, Bouyer B. Are multiple platelet-rich plasma injections useful for treatment of chronic patellar tendinopathy in athletes? a prospective study. Am J Sports Med. 2014 Apr;42(4):906-11. doi: 10.1177/0363546513519964. Epub 2014 Feb 11.
- Cole BJ, Karas V, Hussey K, Pilz K, Fortier LA. Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis. Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21. Erratum In: Am J Sports Med. 2017 Apr;45(5):NP10.
- Dragoo JL, Wasterlain AS, Braun HJ, Nead KT. Platelet-rich plasma as a treatment for patellar tendinopathy: a double-blind, randomized controlled trial. Am J Sports Med. 2014 Mar;42(3):610-8. doi: 10.1177/0363546513518416. Epub 2014 Jan 30. Erratum In: Am J Sports Med. 2016 Jul;44(7):NP38.
- Dupley L, Charalambous CP. Platelet-Rich Plasma Injections as a Treatment for Refractory Patellar Tendinosis: A Meta-Analysis of Randomised Trials. Knee Surg Relat Res. 2017 Sep 1;29(3):165-171. doi: 10.5792/ksrr.16.055.
- Filardo G, Kon E, Della Villa S, Vincentelli F, Fornasari PM, Marcacci M. Use of platelet-rich plasma for the treatment of refractory jumper's knee. Int Orthop. 2010 Aug;34(6):909-15. doi: 10.1007/s00264-009-0845-7. Epub 2009 Jul 31.
- Hansen M, Boesen A, Holm L, Flyvbjerg A, Langberg H, Kjaer M. Local administration of insulin-like growth factor-I (IGF-I) stimulates tendon collagen synthesis in humans. Scand J Med Sci Sports. 2013 Oct;23(5):614-9. doi: 10.1111/j.1600-0838.2011.01431.x. Epub 2012 Jan 31.
- Ionita CR, Troillet AR, Vahlenkamp TW, Winter K, Brehm W, Ionita JC. Comparison of humoral insulin-like growth factor-1, platelet-derived growth factor-BB, transforming growth factor-beta1, and interleukin-1 receptor antagonist concentrations among equine autologous blood-derived preparations. Am J Vet Res. 2016 Aug;77(8):898-905. doi: 10.2460/ajvr.77.8.898.
- Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004.
- Muir SM, Reisbig N, Baria M, Kaeding C, Bertone AL. The Concentration of Plasma Provides Additional Bioactive Proteins in Platelet and Autologous Protein Solutions. Am J Sports Med. 2019 Jul;47(8):1955-1963. doi: 10.1177/0363546519849671. Epub 2019 May 24.
- Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.
- Scott A, LaPrade RF, Harmon KG, Filardo G, Kon E, Della Villa S, Bahr R, Moksnes H, Torgalsen T, Lee J, Dragoo JL, Engebretsen L. Platelet-Rich Plasma for Patellar Tendinopathy: A Randomized Controlled Trial of Leukocyte-Rich PRP or Leukocyte-Poor PRP Versus Saline. Am J Sports Med. 2019 Jun;47(7):1654-1661. doi: 10.1177/0363546519837954. Epub 2019 Apr 30.
- Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.
- Vetrano M, Castorina A, Vulpiani MC, Baldini R, Pavan A, Ferretti A. Platelet-rich plasma versus focused shock waves in the treatment of jumper's knee in athletes. Am J Sports Med. 2013 Apr;41(4):795-803. doi: 10.1177/0363546513475345. Epub 2013 Feb 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019H0437
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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