NCT01850771

Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

A Single-Blinded, Randomized Controlled Trial of Regenexx™ PL-Disc Versus Steroid Epidurals for Treatment of Lumbar Radiculopathy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Regenexx, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx PL-Disc vs. steroid epidural for treatment of lumbar radiculopathy, from baseline to 3 months, with continued evaluation of efficacy and durability up to 12 months. Secondary objectives include incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.

Detailed description

Prospective, single-blinded, randomized, controlled to include 25 subjects treated with Regenexx PL-Disc and 25 subjects treated with steroid epidural injection with the steroid epidural group crossing over to the PL-Disc injection group at 3 months. Subjects will have symptoms consistent with lumbar radiculopathy confirmed by physical examination. Subjects will be enrolled within 60 days prior to injection and take part in follow-up visits for one year following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months and 12 months post injection. Subjects will remain blinded to the treatment allocation through at least the 3 month primary endpoint. Control subjects not improving after the 3 month visit will be unblinded and given the opportunity to cross-over to the PL-Disc group. Subjects will complete the study following the 1 year follow-up visit.

Conditions

• Radiculopathy
• Herniated Disc
• Disc Degeneration

Interventions

Type	Name	Description
PROCEDURE	Regenexx PL-Disc	Injection into the epidural space under image guidance of autologous, concentrated peripheral blood based platelet mix combined with a nanogram dose of corticosteroid.
PROCEDURE	Steroid Epidural	Injection into the epidural space under image guidance of 3 mg of betamethasone.

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2013-05-09
• Last updated: 2016-06-03

Locations

1 site across 1 country: United States