dHACM in Lumbar Decompression and Microdiscectomy Surgery

MiMedx

Status: Completed

Conditions: Scarring; Herniated Disc; Spinal Stenosis

Treatments: Other: Dehydrated Human Amnion/Chorion Membrane (dHACM); Procedure: Microdiscectomy Surgery; Procedure: Lumbar Decompression Surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02300909

AFLUD001

Details and patient eligibility

About

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

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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143 participants in 2 patient groups

dHACM

Experimental group

Description:

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

Treatment:

Other: Dehydrated Human Amnion/Chorion Membrane (dHACM)

Procedure: Microdiscectomy Surgery

Procedure: Lumbar Decompression Surgery

Surgery without dHACM

Other group

Description:

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

Treatment:

Procedure: Microdiscectomy Surgery

Procedure: Lumbar Decompression Surgery