Herniated Disc, Scarring, Spinal Stenosis
Conditions
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.
Interventions
PROCEDURELumbar Decompression Surgery
Lumbar Decompression Surgery
PROCEDUREMicrodiscectomy Surgery
Microdiscectomy Surgery
OTHERDehydrated Human Amnion/Chorion Membrane (dHACM)
Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)
Sponsors
Hospital for Special Surgery, New York
MiMedx Group, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index | 2 years | Patient Functional Outcomes Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scar formation in revision cases | 2 years | Dissection of scar formation required at re-operation |
| Quality of Life (VAS Pain) | 2 years | VAS Pain |
| Re-operation (Number of patients having re-operation during study) | 2 years | Number of patients having re-operation during study |
| Quality of Life | 2 years | HSS Lumbar Expectations Survey |
| Quality of Life (SF-36) | 2 years | SF-36 |
Other
| Measure | Time frame |
|---|---|
| MRI findings in first 20 patients | 3 months post-op |
Countries
United States
Outcome results
None listed