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PRP vs PRP Plus IGF for Patellar Tendinosis

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ClinicalTrials.gov Identifier: NCT04350827
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Baria, Ohio State University

Brief 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.


Condition or disease Intervention/treatment Phase
Tendinopathy Patellar Ligament Platelet-Rich Plasma Device: Platelet Rich Plasma Device: Platelet Rich Plasma plus IGF Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blinded randomized comparative trial.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Platelet-rich Plasma Versus Platelet-rich Plasma Plus Concentrated Insulin-like Growth Factor for Patellar Tendinosis: a Randomized Comparative Trial
Actual Study Start Date : February 25, 2020
Estimated Primary Completion Date : February 25, 2022
Estimated Study Completion Date : February 25, 2023

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.
Device: Platelet Rich Plasma
Platelet rich plasma injection into patellar tendon

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




Primary Outcome Measures :
  1. Victorian Institute of Sport Assessment-patellar tendon (VISA-P) [ Time Frame: 6 months ]
    A questionnaire that assesses symptoms, simple tests of function, and ability to play sports..


Secondary Outcome Measures :
  1. Visual analog scale-Pain with ADL and Sport [ Time Frame: 6 months ]
    Subjective measure for pain

  2. Tegner Activity Scale [ Time Frame: 6 months ]
    a one-item score that graded activity based on work and sports activities on a scale of 0 to 10

  3. Blazina Classification [ Time Frame: 6 months ]
    Classification scale for functional limitations associated with patellar tendinitis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350827


Contacts
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Contact: Michael Baria, MD 614-293-8196 michael.baria@osumc.edu

Locations
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United States, Ohio
The Ohio State University Sports Medicine Center Recruiting
Columbus, Ohio, United States, 43221
Contact: Angela Pedroza, MPH    614-293-7952    angela.pedroza@osumc.edu   
Principal Investigator: Michael Baria, MD         
Sub-Investigator: Timothy Miller, MD         
Sponsors and Collaborators
Ohio State University
Publications:

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Responsible Party: Michael Baria, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT04350827    
Other Study ID Numbers: 2019H0437
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries