To evaluate the efficacy of full thickness placental allograft use in Microdiscectomy application. To evaluate post-microdiscectomy reherniation rate in patients treated with full-thickness placental allografts.
The primary objective is to evaluate the efficacy of full thickness placental allograft use in improving back and leg pain, when applied to patients undergoing lumbar microdiscectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
27
A full-thickness placental allograft will be applied to the annulus of the index lumbar level prior to site closure.
Polaris Spine and Neurosurgery
Atlanta, Georgia, United States
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
Oswestry Disability Index (ODI)
Time frame: 24 months
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
12-Item Short Form Survey (SF12)
Time frame: 24 months
Evaluation of post-microdiscectomy reherniation rate.
Reherniation rates will be compared between the experimental and control groups.
Time frame: 24 month
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