Platelet-rich fibrin to reduce pain after lumbar disc surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-blind, phase 3 study compares adding periradicular platelet-rich fibrin (PRF) during lumbar disc herniation surgery to the standard surgical approach. Participants are adults with lumbar radiculopathy planned for surgery and are assigned to receive either PRF or usual care. Outcomes are evaluated by a blinded assessor to determine the effect on residual post-surgical neuropathic pain. The trial is conducted at a single center in Strasbourg, France, and is sponsored by the University Hospital Strasbourg. Safety and tolerability of the intraoperative PRF application are also monitored.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Patient, male or female, \>18 years old at the time of signing informed consent;
* Patient for whom a diagnosis of radiculopathy on lumbar disc herniation has been made, and for whom surgery has been scheduled in the Neurosurgery department;
* Patient affiliated to a social security health insurance scheme;
* Patient able to understand the objectives and risks of research and to give informed, dated and signed consent;
* Patient having been informed of the results of the prior medical examination;
* Women of childbearing age provided that a negative blood pregnancy test is recorded at the inclusion visit and effective contraception used throughout the study.

Exclusion criteria:

* Patient with a history of lumbar spinal surgery (multiple herniated discs, herniated disc other than lumbar);
* Patient with HIV, active cancer, HBV, HCV (verified by interview);
* Patient on long-term systemic corticosteroid therapy;
* Patient with an ASA score \> 3 during the consultation with the anesthesiologist;
* Inability to give the patient informed information (patient in an emergency or life-threatening situation, difficulties in understanding);
* Patient in exclusion period (determined by a previous or ongoing study);
* Subject under safeguard of justice;
* Subject under curatorship;
* Pregnancy;
* Breastfeeding.

Where it's running

• Les Hôpitaux Universitaires
  Strasbourg, Bas-Rhin, France Recruiting

Study contacts

• Study coordinator: Erci SALVAT
• Email: eric.salvat@chru-strasbourg.fr
• Phone: +33 3 88 12 85 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.