dHACM in Lumbar Decompression and Microdiscectomy Surgery

Not Applicable

Completed

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

• Registration Number: NCT02300909
• Lead Sponsor: MiMedx Group, Inc.

Brief 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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-25
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery without dHACM	Microdiscectomy Surgery	Control Group - Lumbar Decompression Surgery or Microdiscectomy Surgery without application of dHACM
dHACM	Microdiscectomy Surgery	Lumbar Decompression Surgery or Microdiscectomy Surgery with Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)
dHACM	Lumbar Decompression Surgery	Lumbar Decompression Surgery or Microdiscectomy Surgery with Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)
dHACM	Dehydrated Human Amnion/Chorion Membrane (dHACM)	Lumbar Decompression Surgery or Microdiscectomy Surgery with Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)
Surgery without dHACM	Lumbar Decompression Surgery	Control Group - Lumbar Decompression Surgery or Microdiscectomy Surgery without application of dHACM

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	2 years	Patient Functional Outcomes Questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States