dHACM in Lumbar Decompression and Microdiscectomy Surgery

Completed · Not applicable

Conditions studied: Scarring, Spinal Stenosis, Herniated Disc

In brief

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

Key facts

Study ID

NCT02300909

Run by

MiMedx Group, Inc.

People needed

143

Starts

2014-11-01

Expected to finish

2018-06-01

Last updated by the study team

2018-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Hospital for Special Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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