NCT02477176

Lumbar Discectomy Control Study, Risk Factors for Reherniation

A Prospective, Multicenter Study Investigating Reherniation Risk Factors and Associated Costs in Primary Lumbar Disc Herniation Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Intrinsic Therapeutics · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this 12-month, prospective, multicenter study is to investigate the effect of annular defect size and other risk factors on reherniation and associated costs in primary lumbar discectomy patients.

Detailed description

This study will enroll up to 100 patients at select US (approximately 4-7) sites. Patients that are scheduled for an L1-S1 discectomy and who meet the pre-operative eligibility criteria will be considered for study participation. Patients will be divided into two arms (small- and large-defect) based on the size of their annular defect as measured intra-operatively; each arm will be capped at 50 patients. All patients included in the trial will be followed for at least 12 months.

Conditions

• Lumbar Spine Disc Herniation

Interventions

Type	Name	Description
OTHER	Discectomy	Lumbar discectomy

Timeline

• Start date: 2016-02-17
• Primary completion: 2024-03-01
• Completion: 2025-03-01
• First posted: 2015-06-22
• Last updated: 2023-09-28

Locations

4 sites across 1 country: United States