Intradiscal and Intra-articular Injection of Autologous Platelet-Rich-Plasma (PRP) in Patients With Lumbar Degenerative Disc Disease and Facet Joint Syndrome

Summary

Autologous Platelet-Rich-Plasma (PRP) represents a regenerative therapy that has gained remarkable ground in the field of orthopaedics in recent years. PRP has been implemented for a plethora of musculoskeletal ailments, being associated with minor complications and noteworthy efficacy (Akeda et al., 2019). PRP has been depicted to contain a variety of growth factors crucial for regulation of cell proliferation and migration as well as extracellular matrix synthesis (Cheng et al., 2019). Furthermore, therapeutic effect of PRP administration is considered to be additionally exerted via its anti-inflammatory and immunoregulative properties, as it has been delineated to induce regional decrease of pro-inflammatory mediators at the injection site (Hirase et al., 2020).

Lumbar Degenerative Disc Disease (DDD) and Facet Joint Syndrome (FJS) constitute chronic degenerative conditions of lumbar spine that have been associated with substantial morbidity and disability in recent years. Besides the noted progress in comprehension of these conditions' pathogenesis, available therapeutic modalities remain extremely limited and controversial, being not capable of altering the natural progress of underlying disease (Wu et al., 2016; Wu et al., 2017; Hirase et al., 2020).

Autologous PRR has been recommended as a beneficial alternative instead of conventional treatment strategies for interventional management of lumbar DDD and FJS (Aufiero et al., 2015; Navani and Hames, 2015; Kirchner and Anitua, 2016; Levi et al., 2016; Tuakli-Wosornu et al., 2016; Wu et al., 2016; Akeda et al., 2017; Lutz GE, 2017; Wu et al., 2017; Cheng et al., 2019). Results of these studies indicated that intra-discal and intra-articular injection of PRP for DDD and FJS respectively is characterized by safety and satisfactory efficacy in reducing intensity of clinical manifestations, exerting also potentially regenerative effects. However, quality of available evidence is remarkably low, since in the overwhelming majority of these studies was a limited number of patients evaluated. Furthermore, determined follow-up intervals were not extended and, most importantly, patients were not majorly with rigorous clinical and radiologic criteria selected.

Aim of this study is to investigate the precise effects of intradiscal and intra-articular injection of PRP in patients with early-stage lumbar DDD and FJS, as determined by particular radiologic classifications. The prospective design, the defined greater number of recruited individuals in pilot analysis as well as the comparatively greater follow-up underline the originality of our protocol.

Conditions

• Degenerative Disc Disease
• Facet Joint Syndrome

Interventions

BIOLOGICAL

Autologous PRP

Participants enrolled in this study will be managed with intradiscal and/or intra-articular injections of autologous PRP according to features of underlying pathology. Participants featuring FJS will be prior to PRP diagnostically and therapeutically injected with local anesthetic in order to verify FJS as the etiology of experienced pain. Injected PRP solution volume is designed to be 0.5-1 ml and 0.5 ml in cases of intradiscal and intra-articular injection, respectively. All participants are planned to receive a single dose of PRP, whilst a maximum of two compromised discs and four facet joints will be treated in each patient.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki

  collaborator OTHER

• Stylianos Kapetanakis

  lead OTHER

Principal Investigators

• Stylianos Kapetanakis, Assistant Professor · Spine Department and Deformities, Interbalkan European Medical Center, Thessaloniki, PC 55535, Greece; Department of Minimally Invasive and Endoscopic Spine Surgery, Athens Medical Center, Athens, PC 15124, Greece

• Nikolaos Gkantsinikoudis, PhD Candidate · Spine Department and Deformities, Interbalkan European Medical Center, Thessaloniki, PC 55535, Greece

• Aristeidis Kritis, Associate Professor · Department of Physiology and Pharmacology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki (A.U.Th), Thessaloniki, PC 54124, Greece

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-30

Primary Completion

2024-10-31

Completion

2024-10-31