CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients

Completed · Phase 4

Conditions studied: Protruded Disk

In brief

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.

Key facts

Study ID: NCT03113786
Run by: Amniox Medical, Inc.
People needed: 32
Starts: 2011-11-02
Expected to finish: 2020-04-21
Last updated by the study team: 2020-07-15

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Rothman Institute — Bensalem, Pennsylvania, United States

Full record on ClinicalTrials.gov

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