NCT02300909

dHACM in Lumbar Decompression and Microdiscectomy Surgery

A Randomized, Single Blind, Controlled Trial of Clinical Outcomes of Dehydrated Human Amnion/Chorion Membrane (dHACM) in Lumbar Decompression and Microdiscectomy Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: MiMedx Group, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.

Detailed description

The objective of this prospective study is to evaluate the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients randomized to one of two groups: 1) without dHACM (control) or 2) dHACM.

Conditions

• Scarring
• Spinal Stenosis
• Herniated Disc

Interventions

Type	Name	Description
PROCEDURE	Lumbar Decompression Surgery	Lumbar Decompression Surgery
PROCEDURE	Microdiscectomy Surgery	Microdiscectomy Surgery
OTHER	Dehydrated Human Amnion/Chorion Membrane (dHACM)	Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2014-11-25
• Last updated: 2018-08-23

Locations

1 site across 1 country: United States