CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients

NCT03113786 | Completed Phase 4

• 1 other identifier: CR-1001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Protruded Disk

Keywords

Discectomy; Lumbar discectomy; Protruding disc

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Standard of Care

NO INTERVENTION

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

CLARIX™100

ACTIVE COMPARATOR

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

CLARIX CORD 1K

ACTIVE COMPARATOR

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

Interventions

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™100

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.

CLARIX CORD 1K

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Amniox Medical, Inc.: lead

Study Sites (1)

Rothman Institute

Bensalem, Pennsylvania, 19020, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Scheffer Tseng, MD, PhD

  BioTissue Holdings, Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 14, 2017
• Study Start: November 2, 2011
• Primary Completion: April 21, 2020
• Study Completion: April 21, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)