Clinical trial NCT03113786: CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients
Official title: Efficacy of Amniotic Tissue (CLARIX 100 & CLARIX CORD 1K) in Pain Reduction and Improvement of Function in Low Back & Leg Pain in Discectomy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Protruded Disk
Keywords: Discectomy
Lumbar discectomy
Protruding disc
Lead sponsor: Amniox Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in low back & leg pain
timeFrame: 5 years
measure: Difference in low back & leg pain
timeFrame: 5 years
measure: Difference in low back & leg pain
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bensalem
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
affiliation: BioTissue Holdings, Inc
name: Scheffer Tseng, MD, PhD
role: STUDY_CHAIR
References: