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

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

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis; Herniated Disc; Scarring
• Intervention / Treatment: Procedure: Lumbar Decompression Surgery; Procedure: Microdiscectomy Surgery; Other: Dehydrated Human Amnion/Chorion Membrane (dHACM)

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Are 18 (eighteen) years of age or older at the time of surgery.
2. Patients with single- or multi-level spinal stenosis undergoing open lumbar laminectomy, or patients with single-level herniated nucleus pulposus undergoing single-level lumbar microdiscectomy
3. Are willing and able to return for the scheduled follow-up visits, follow post operative instructions and undergo the required radiographic exams for up to 5 time points between 4 weeks and 24 months post-surgery (6 weeks ± 2 weeks, 12 weeks ± 2 weeks, 6 months ±1 month, 1 year±2 months, and 2 years ±2 months post-surgery), including one study MRI-scan at 12 weeks ±2 weeks for the first 20 patients enrolled.
4. Are willing and able to sign study specific informed consent.

Exclusion Criteria:

1. Non-English speaking patients
2. Non-surgical candidate defined as any patient deemed by the surgeon not to be a surgical candidate cannot participate for the following reasons: that patient does not meet indications for lumbar laminectomy or microdiscectomy surgery, patient has a contraindication to surgery such as medical comorbidities, pregnancy, etc.
3. Allergic to aminoglycoside antibiotics
4. Is a prisoner
5. Is involved in worker's compensation or other litigation relative to the spine injury
6. Has a history of drug or alcohol abuse within the last 12 months
7. Is currently participating in another drug or device clinical trial
8. Previous spinal surgery
9. History of deformity, mechanical instability, or spinal fusion requirement
10. History of hard- or soft-tissue spinal infection
11. Has signs or symptoms of any disease, such as autoimmune disease, which could result in allograft failure, or has experienced allograft failure in the past
12. Patients unable to undergo a MRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dHACM; Lumbar Decompression Surgery or Microdiscectomy Surgery with Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)	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)
Other: Surgery without dHACM; Control Group - Lumbar Decompression Surgery or Microdiscectomy Surgery without application of dHACM	Procedure: Lumbar Decompression Surgery; Lumbar Decompression Surgery; Procedure: Microdiscectomy Surgery; Microdiscectomy Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index	Patient Functional Outcomes Questionnaire	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-operation (Number of patients having re-operation during study)	Number of patients having re-operation during study	2 years
Scar formation in revision cases	Dissection of scar formation required at re-operation	2 years
Quality of Life (VAS Pain)	VAS Pain	2 years
Quality of Life (SF-36)	SF-36	2 years
Quality of Life	HSS Lumbar Expectations Survey	2 years

Other Outcome Measures

Outcome Measure	Time Frame
MRI findings in first 20 patients	3 months post-op

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.
• Collaborators: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Alexander Hughes, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimate): November 25, 2014

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Spinal Stenosis
• Other Study ID Numbers: AFLUD001