Status:
COMPLETED
dHACM in Lumbar Decompression and Microdiscectomy Surgery
Lead Sponsor:
MiMedx Group, Inc.
Collaborating Sponsors:
Hospital for Special Surgery, New York
Conditions:
Scarring
Spinal Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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) with...
Eligibility Criteria
Inclusion
- Are 18 (eighteen) years of age or older at the time of surgery.
- 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
- 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.
- Are willing and able to sign study specific informed consent.
Exclusion
- Non-English speaking patients
- 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.
- Allergic to aminoglycoside antibiotics
- Is a prisoner
- Is involved in worker's compensation or other litigation relative to the spine injury
- Has a history of drug or alcohol abuse within the last 12 months
- Is currently participating in another drug or device clinical trial
- Previous spinal surgery
- History of deformity, mechanical instability, or spinal fusion requirement
- History of hard- or soft-tissue spinal infection
- 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
- Patients unable to undergo a MRI
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT02300909
Start Date
November 1 2014
End Date
June 1 2018
Last Update
August 23 2018
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021