dHACM in Lumbar Decompression and Microdiscectomy Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2018-06-30

Brief Summary

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

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Detailed Description

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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

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Scarring Spinal Stenosis Herniated Disc

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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dHACM

Lumbar Decompression Surgery or Microdiscectomy Surgery with Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)

Group Type EXPERIMENTAL

Lumbar Decompression Surgery

Intervention Type PROCEDURE

Lumbar Decompression Surgery

Microdiscectomy Surgery

Intervention Type PROCEDURE

Microdiscectomy Surgery

Dehydrated Human Amnion/Chorion Membrane (dHACM)

Intervention Type OTHER

Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)

Surgery without dHACM

Control Group - Lumbar Decompression Surgery or Microdiscectomy Surgery without application of dHACM

Group Type OTHER

Lumbar Decompression Surgery

Intervention Type PROCEDURE

Lumbar Decompression Surgery

Microdiscectomy Surgery

Intervention Type PROCEDURE

Microdiscectomy Surgery

Interventions

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Lumbar Decompression Surgery

Intervention Type PROCEDURE

Microdiscectomy Surgery

Intervention Type PROCEDURE

Dehydrated Human Amnion/Chorion Membrane (dHACM)

Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No