Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
143
Lumbar Decompression Surgery
Microdiscectomy Surgery
Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)
Hospital for Special Surgery
New York, New York, United States
Oswestry Disability Index
Patient Functional Outcomes Questionnaire
Time frame: 2 years
Re-operation (Number of patients having re-operation during study)
Number of patients having re-operation during study
Time frame: 2 years
Scar formation in revision cases
Dissection of scar formation required at re-operation
Time frame: 2 years
Quality of Life (VAS Pain)
VAS Pain
Time frame: 2 years
Quality of Life (SF-36)
SF-36
Time frame: 2 years
Quality of Life
HSS Lumbar Expectations Survey
Time frame: 2 years
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