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dHACM in Lumbar Decompression and Microdiscectomy Surgery

NCT02300909 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2018-08-23

No results posted yet for this study

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.

Conditions

  • Scarring
  • Spinal Stenosis
  • Herniated Disc

Interventions

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)

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    collaborator OTHER

  • MiMedx Group, Inc.

    lead INDUSTRY

Principal Investigators

  • Alexander Hughes, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT02300909 on ClinicalTrials.gov