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Nucleoplasty for Contained Herniated Lumbar Discs

NCT00124774 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2008-04-01

No results posted yet for this study

Summary

This is a prospective randomised double blind comparison trial. Fifty patients will be included, 25 in the nucleoplasty treatment group, 25 in the control group. The nucleoplasty group will undergo the nucleoplasty treatment. Control group will undergo a sham treatment. Both groups will undergo a standardised post-operative care program. The study hypothesis is that nucleoplasty will lead to earlier pain reduction as compared with the sham treatment.

Conditions

  • Herniated Disc

Interventions

PROCEDURE

Nucleoplasty

Sponsors & Collaborators

  • Maastricht University

    collaborator OTHER

  • ArthroCare Corporation

    collaborator OTHER

  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • Michel Terheggen, MD · Rijnstate Hospital

  • Maarten van Kleef, MD, PhD · UMC Maastricht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Completion
2006-04-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00124774 on ClinicalTrials.gov