The Effect of Platelet Rich Plasma for the Treatment of Osteochondral Lesions of the Talus

The Effect of Platelet Rich Plasma for the Treatment of Osteochondral Lesions of the Talus: Randomized Controlled Trial

Osteochondral lesion of the talus (OCL) results from the detachment of the talar cartilage which could also be associated with subchondral bone fragmentation due to trauma. OCL can be managed conservatively by immobilization and weight bearing restriction or surgically to stimulate the regeneration and the formation of fibrous cartilage including reparative or replacement approaches. OCL surgical intervention includes bone marrow stimulation or autologous osteochondral transplantation while the cartilage regeneration was found unsatisfactory with these interventions. However, introducing platelet rich plasma (PRP) as an adjacent intervention could enhance the cartilage regeneration in OCL due to the release of growth factors and bioactive components, which could in turn reduce the need for replacement interventions and improve the regeneration of the cartilage.

The literature was reviewed, and four randomized controlled trials have been found exploring the effect of PRP in OCL where both ankle function and pain were examined. The results of the previous studies have proved the effectiveness of PRP in managing OCL as an adjunct to microfracture surgery in improving ankle function and reducing pain which was superior to the surgical intervention alone and also superior to the injection of PRP alone. Despite the promising results, the previous studies were limited to several factors. There was a lack of blinding which could risk the results to expectation bias, and the follow up period was short in according to the MCMS, which is needed to monitor the long-term effect of the PRP and to document any potential adverse effects or relapse in the function. Additionally, all the previous studies performed blind injection. Additionally, the previous studies have not controlled the administration of analgesic which could risk the results of the pain effect.

The proposed study aims to examine the effect of PRP in the management of OCL using randomized double-blind control trial design to eliminate any expectation bias. Patients will be followed up for 12 months, and the PRP will be administered intra-operatively. Moreover, PRP concentration will be standardized. Analgesic will be controlled and documented as a confounded factor. Additionally, the quality of the repaired tissue and the regeneration of the hyaline cartilage will be examined using MRI at the end of the follow-up. Therefore, the study aims to examine the effectiveness of PRP in OCL using randomized controlled trial design.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteochondral Lesions of the Talus
• Intervention / Treatment: Biological: platelet rich plasma

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Najla Alsiri, PhD; Phone Number: 00965-66820032; Email: dr.alsiri@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Diagnosis of OCL, which will be confirmed with radiographs and magnetic resonance imaging.
• aged > or = 18 years < 60 year
• complain of ankle pain.

Exclusion Criteria:

• posterior OCL
• pregnancy
• ankle infection
• teroid injection within 6 months
• surgery of the involved joint with 6 months
• received glucosamine and/or chondroitin sulfate, or anticoagulant
• Systematic inflammatory condition
• substantial venous or lymphatic stasis in the legs
• Pathologies that my confound pain and functional assessment in the ankle (plantar fasciitis, Achilles tendonitis, sprains, and degenerative joint disease of the foot.
• Allergy to any of the component of the PRP injection, disabling degenerative joint disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osteochondral lesions of the talus group; Patients will receive PRP injection.	Biological: platelet rich plasma; platelet rich plasma injection; Other Names: platelet rich plasma injection
Placebo Comparator: Control group; Patients will receive saline injection.	Biological: platelet rich plasma; platelet rich plasma injection; Other Names: platelet rich plasma injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
American Orthopedic Foot and Ankle (AOFAS) score	12 months

Collaborators and Investigators

• Sponsor: Ministry of Health, Kuwait

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1736/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No