CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients

Amniox Medical

Status and phase: Completed; Phase 4

Conditions: Protruded Disk

Treatments: Other: CLARIX™100; Other: CLARIX CORD 1K

Study type: Interventional

Funder types: Industry

Identifiers

NCT03113786

CR-1001

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 3 patient groups

Standard of Care

No Intervention group

Description:

Subjects randomized to standard of care will undergo a traditional lumbar discectomy procedure without any additional interventions

CLARIX™100

Active Comparator group

Description:

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.

Treatment:

Other: CLARIX™100

CLARIX CORD 1K

Active Comparator group

Description:

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.

Treatment:

Other: CLARIX CORD 1K