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Completed

NCT Number: NCT03113786

CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients

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.

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Key information

Conditions

Protruded Disk Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rothman Institute

Bensalem, Pennsylvania, 19020, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CLARIX™100

Other

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).

CLARIX CORD 1K

Other

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.

Primary outcomes

  1. Difference in low back & leg pain

    Time frame: 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

  2. Difference in low back & leg pain

    Time frame: 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 SF-12 scale for both back & leg pain

  3. Difference in low back & leg pain

    Time frame: 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 VAS for both back & leg pain

Sponsors and collaborators

Lead sponsor

Amniox Medical, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2017
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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