The purpose of the study is to evaluate the efficacy of CLARIX™ 100 and CLARIX™ CORD 1K as a tissue barrier when used as an annular patch in discectomy patients with low back \& leg pain when compared to traditional discectomy patient outcomes. This will be a 120 patient, prospective randomized study model over a 5 year post-operative period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
CLARIX™100 is Amniox's processed and cryopreserved human amniotic membrane tissue retrieved from donated placental tissue after elective Cesarean Section delivery. Amniox's Amniotic Membrane is designated by the FDA as a tissue product under PHS 361 HCT/P (human cells, tissues and cellular and tissue-based products).
CLARIX CORD 1K is made from cryopreserved human umbilical cord, utilizing the patented CRYOTEK™ process. CLARIX CORD 1K is considered a Human Cells, Tissues \& Cellular and Tissue-based product (HCT/P) by U.S. FDA standards.
Rothman Institute
Bensalem, Pennsylvania, United States
Difference in low back & leg pain
To determine at various time points up to 5 years what, if any, difference there is between the three groups of 40 patients by using the Oswestry Disability Index scales for both back \& leg pain
Time frame: 5 years
Difference in low back & leg pain
To determine at various time points up to 5 years what, if any, difference there is between the three groups of 40 patients by using the SF-12 scale for both back \& leg pain
Time frame: 5 years
Difference in low back & leg pain
To determine at various time points up to 5 years what, if any, difference there is between the three groups of 40 patients by using the VAS for both back \& leg pain
Time frame: 5 years
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