CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Amniotic Tissue (CLARIX 100 & CLARIX CORD 1K) in Pain Reduction and Improvement of Function in Low Back & Leg Pain in Discectomy Patients

Conditions
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Protruded Disk

Intervention / Treatment
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* Other: CLARIX™100
* Other: CLARIX CORD 1K


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Subjects randomized to standard of care will undergo a traditional lumbar discectomy procedure without any additional interventions | |
| Active Comparator: CLARIX™100<br>Subjects randomized to the CLARIX™100 arm will undergo a traditional lumbar discectomy, after which CLARIX™100 will be applied to the affected site. The tissue will be applied to the annulus at the defect site as a patch just prior to wound closure. | Other: CLARIX™100<br>* 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).<br>|
| Active Comparator: CLARIX CORD 1K<br>Subjects randomized to the CLARIX CORD 1K arm will undergo a traditional lumbar discectomy, after which CLARIX CORD 1K will be applied to the affected site. The tissue will be applied to the annulus at the defect site as a patch just prior to wound closure. | Other: CLARIX CORD 1K<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Discectomy, Lumbar discectomy, Protruding disc