Protruded Disk
Conditions
Keywords
Discectomy, Lumbar discectomy, Protruding disc
Brief summary
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.
Interventions
OTHERCLARIX™100
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).
OTHERCLARIX CORD 1K
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.
Sponsors
Amniox Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients between 18 and 90 years of age * Patient is able to understand the aims and objectives of the trial and the trial procedures * Patient is willing to give written informed consent to the trial * Patient is able to follow up with regularly scheduled visits with and phone calls from Dr. Anderson and his research staff * Diagnosed with lumbar protruding disc * Suffer from radiating leg pain and low back pain that has failed a minimum of 6 months of conservative (non-operative) treatment options
Exclusion criteria
* Participation in clinical trial involving therapy for back pain within 30 days of screening * Prior back surgery at the same level * Inability to walk independently (adaptive devices such as walkers or canes are allowed) * Relation (whether direct or indirect) to, student of, employee of, colleague of, indebted to the primary investigator, host institution or sponsoring company * Receipt of corticosteroids, immunosuppressive agents, radiation therapy or chemotherapy within 1 month prior to visit * Pregnancy or planning to become pregnant during study period * Body Mass Index \>50 * Patients with chronic diseases such as Crohn's disease, severe renal failure (serum creatinine 2.5 mg/dL or subject on hemodialysis), severe hepatic insufficiency: known cirrhosis, any degree of ascites, serum transaminases more than 3 times the upper limit of normal, life expectancy of less than one year, uncompensated or uncontrolled right sided heart failure with associated edema * Severe anemia, hemoglobin \<8.5 mg/dL * Active, local or systemic malignancy such as lung cancer or leukemia * Severe hypertension (systolic blood pressure greater than or equal to 200 mmHg or diastolic blood pressure greater than or equal to 100 mmHg) * Severe hypoxia, with chronic oxygen or ventilation therapy * History of collagen vascular disease or sickle cell anemia * Active rheumatoid arthritis * Systemic antibiotic therapy for any indication within 10 days of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in low back & leg pain | 5 years | 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 |
Countries
United States
Outcome results
None listed