PRP vs PRP Plus IGF for Patellar Tendinosis

Tendinopathy Clinical Trial

Official title:

Platelet-rich Plasma Versus Platelet-rich Plasma Plus Concentrated Insulin-like Growth Factor for Patellar Tendinosis: a Randomized Comparative Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04350827
• Other study ID #: 2019H0437
• Status: Completed
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: October 16, 2021

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 16, 2021
• Est. primary completion date: October 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patellar Ligament
• Platelet-Rich Plasma
• Tendinopathy

Intervention

Device:
• Platelet Rich Plasma
Platelet rich plasma injection into patellar tendon
• Platelet Rich Plasma plus IGF
Platelet rich plasma plus IGF injection into patellar tendon

Locations

Country	Name	City	State
United States	The Ohio State University Sports Medicine Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Victorian Institute of Sport Assessment-patellar Tendon (VISA-P)	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.	6 months
Secondary	Visual Analog Scale-Pain	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').	6 months
Secondary	Tegner Activity Scale	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.	6 months
Secondary	Blazina Classification	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	6 months