D Greg Anderson1, Victor Popov, Andrew L Raines, Julie O'Connell. 1. *Department of Orthopaedic Surgery and Neurological Surgery, Thomas Jefferson University †Rothman Institute, Philadelphia, PA ‡Amniox Medical Inc., Atlanta, GA.
Abstract
STUDY DESIGN: Prospective, randomized controlled trial. OBJECTIVE: To compare pain, physical/mental functional recovery and recurrent herniation for patients following lumbar microdiscectomy with and without the use of a cryopreserved amniotic tissue graft. SUMMARY OF BACKGROUND DATA: Although microdiscectomy procedures are routinely successful for patients with lumbar radiculopathy due to herniated disc disease, residual low back pain, and recurrent herniation remain unsolved clinical problems. METHODS: Following Investigated Review Board approval, 80 subjects were randomized in a 1:1 ratio to either receivecryopreserved amniotic (cAM) tissue or no tissue following elective lumbar microdiscectomy surgery. cAM grafts were applied to the annular defect at the conclusion of the procedure. Patients provided preoperative and postoperative clinical assessment data out to 24 months using the Oswestry Disability Index (ODI), Short Form-12 (SF-12) Health Survey, and Visual Analog Pain Scale for back and leg pain. Patients with symptomatic recurrent disc herniation were recorded. RESULTS: In total, 48 males and 32 females with an average age of 47.2 years were included. Mean ODI scores for subjects treated with cAM graft demonstrated statistically greater improvement at 6 weeks (14.49 vs. 21.82; P=0.05) and 24 months (6.62 vs. 14.40; P=0.02) compared with controls. Similarly, SF-12Physical Component Scores demonstrated statistically greater gains in the cAM group at both the 6 weeks and 24 months. None of the subjects in the cAM graft group sustained a recurrent herniation at the same surgical level, whereas 3 patients in the control group sustained a recurrent herniation at the same surgical level, with 2 requiring fusion to manage persistent pain. CONCLUSIONS: The data demonstrate statistically superior clinical outcomes following lumbar microdiscectomy as measured by ODI and SF-12 (physical composite scale) and a lower rate of recurrent herniation with the use of a cAM tissue graft compared with traditional microdiscectomy.
RCT Entities:
STUDY DESIGN: Prospective, randomized controlled trial. OBJECTIVE: To compare pain, physical/mental functional recovery and recurrent herniation for patients following lumbar microdiscectomy with and without the use of a cryopreserved amniotic tissue graft. SUMMARY OF BACKGROUND DATA: Although microdiscectomy procedures are routinely successful for patients with lumbar radiculopathy due to herniated disc disease, residual low back pain, and recurrent herniation remain unsolved clinical problems. METHODS: Following Investigated Review Board approval, 80 subjects were randomized in a 1:1 ratio to either receive cryopreserved amniotic (cAM) tissue or no tissue following elective lumbar microdiscectomy surgery. cAM grafts were applied to the annular defect at the conclusion of the procedure. Patients provided preoperative and postoperative clinical assessment data out to 24 months using the Oswestry Disability Index (ODI), Short Form-12 (SF-12) Health Survey, and Visual Analog Pain Scale for back and leg pain. Patients with symptomatic recurrent disc herniation were recorded. RESULTS: In total, 48 males and 32 females with an average age of 47.2 years were included. Mean ODI scores for subjects treated with cAM graft demonstrated statistically greater improvement at 6 weeks (14.49 vs. 21.82; P=0.05) and 24 months (6.62 vs. 14.40; P=0.02) compared with controls. Similarly, SF-12 Physical Component Scores demonstrated statistically greater gains in the cAM group at both the 6 weeks and 24 months. None of the subjects in the cAM graft group sustained a recurrent herniation at the same surgical level, whereas 3 patients in the control group sustained a recurrent herniation at the same surgical level, with 2 requiring fusion to manage persistent pain. CONCLUSIONS: The data demonstrate statistically superior clinical outcomes following lumbar microdiscectomy as measured by ODI and SF-12 (physical composite scale) and a lower rate of recurrent herniation with the use of a cAM tissue graft compared with traditional microdiscectomy.
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