Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc Disease

November 12, 2018 updated by: Aesculap Implant Systems

Clinical Study to Evaluate the Safety and Effectiveness of the Aesculap Activ-L™ Artificial Disc in the Treatment of Degenerative Disc Disease

The purpose of this study is to learn whether an investigational device called the Activ-L Artificial Disc is safe and effective in the treatment of degenerative disc disease of the lower (lumbar) spine.

Study Overview

Detailed Description

The objective of this clinical study is to evaluate the safety and effectiveness of the Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar spine in patients who have been unresponsive to at least six months of prior conservative care. The hypothesis of the study is that the Activ-L Disc is non-inferior to the control (the Charité® Artificial Disc [DePuy Spine] or ProDisc-L® Total Disc Replacement [Synthes Spine]) with respect to the rate of individual subject success at 24 months. Individual subject success is a composite of effectiveness and safety.

Study Type

Interventional

Enrollment (Actual)

376

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital La Jolla
      • Newport Beach, California, United States, 92658
        • Hoag Memorial Hospital Presbyterian
      • Rancho Cucamonga, California, United States, 91730
        • Rancho Specialty Hospital
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • Santa Monica, California, United States, 90404
        • St. John's Hospital and Health Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health Sciences Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine/New Haven Hospital
    • Florida
      • Aventura, Florida, United States, 33180
        • Aventura Hospital and Medical Center
      • Tampa, Florida, United States, 33613
        • University Community Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Peoria, Illinois, United States, 61605
        • Neurosciences Education and Research Foundation
    • Minnesota
      • Maplewood, Minnesota, United States, 55109
        • HealthEast St. John's Hospital
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas HealthCare
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Hamot Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 - 60, skeletally mature
  • Symptomatic DDD with objective evidence of lumbar DDD, with any of the following characteristics by MRI scan:

    • instability as defined by ≥ 3mm translation or ≥ 5° angulation.
    • osteophyte formation of facet joints or vertebral endplates.
    • decreased disc height of >2mm as compared to the adjacent level.
    • scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule.
    • herniated nucleus pulposus.
    • facet joint degeneration/changes.
    • vacuum phenomenon.
  • Single level symptomatic disease at L4/L5 or L5/S1.

    • six months of unsuccessful conservative treatment
  • ODI score ≥ 40/100.
  • Surgical candidate for an anterior approach to the lumbar spine.
  • Back pain at the operative level only, with or without leg pain.
  • Back pain VAS score greater than the higher of the two VAS leg pain scores.
  • VAS back pain score ≥ 40/100 mm.
  • Willing to return for follow-up visits and sign an Informed Consent and HIPAA Authorization.

Exclusion Criteria:

  • Previous surgery at any lumbar level, except IDET (Intradiscal Electrothermal Annuloplasty), percutaneous nucleoplasty, or microdiscectomy.
  • Chronic radiculopathy, i.e., subject complaint of unremitting pain with a predominance of leg pain symptoms greater than back pain symptoms extending over a period of at least 1 year.
  • endplate dimensions smaller than 34.5 mm in medial-lateral and/or 27 mm in the anterior-posterior direction
  • Evidence of significant, symptomatic disc degeneration at another lumbar level.
  • Preoperative remaining disc height < 3mm
  • Myelopathy.
  • Previous compression or burst fracture at the affected level.
  • Sequestered herniated nucleus pulposus with migration.
  • Mid-sagittal stenosis of <8mm (by MRI).
  • Degenerative or lytic spondylolisthesis > 3mm.
  • Spondylolysis.
  • Isthmic spondylolisthesis.
  • Lumbar scoliosis (> 11 degrees of sagittal plane deformity).
  • Spinal tumor.
  • Active systemic infection or infection at the site of surgery.
  • Facet ankylosis or severe facet degeneration.
  • Continuing steroid use or prior use for more than 2 months.
  • History of allergies to any of the device components.
  • Pregnancy or planning to become pregnant within the next 2 years.
  • Morbid obesity (BMI >35).
  • Investigational drug or device use within 30 days.
  • Osteoporosis or osteopenia
  • Metabolic bone disease.
  • Leg pain with migrated sequestrum fragment.
  • History of rheumatoid arthritis, lupus, or other autoimmune disorder.
  • Ankylosing spondylitis.
  • History of HIV/AIDS or hepatitis that precludes surgery.
  • History of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolytic disease.
  • Current or recent history of illicit drug or alcohol abuse, or dependence as defined as the continued use of alcohol despite the development of social, legal, or health problems.
  • Life expectancy <5 years.
  • Chemotherapy within past 5 years or any cancer other than non-melanoma skin cancer treated with curative intent within the past 5 years.
  • Prior nephrectomy.
  • Abdominal adhesions, endometriosis, inflammatory bowel disease, Crohn's disease, diverticulitis, ulcerative colitis or other abdominal pathology that would preclude abdominal surgical approach.
  • Insulin-dependent diabetes.
  • Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, ALS (amyotrophic lateral sclerosis), or multiple sclerosis.
  • History of Pelvic Inflammatory Disease.
  • Peritonitis.
  • Currently in active spinal litigation as a result of medical negligence.
  • Prisoner.
  • Psychiatric or cognitive impairment that would interfere with the subject's ability to comply with the study requirements, e.g., Alzheimer's disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
Active Comparator: Control
Implantation of either the ProDisc-L Total Disc Replacement or Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Success at 24 Months Relative to Baseline
Time Frame: 24 months
Measured by absence of treatment failure; absence or serious device related AE; maintenance or improvement of ROM at index level; maintenance or improvement of neurological status; improvement in ODI score.
24 months
Device Success
Time Frame: 24 months
Percent of subjects demonstrating no Subsequent Surgical Interventions (SSI's) at the index level (L4-L5 or L5-S1) at 24 months.
24 months
Absence of Serious Device Related Adverse Events
Time Frame: 24 months
Percent of subjects demonstrating no device related SAE's at 24 months as per the Clinical Events Committee (CEC)
24 months
Range of Motion (ROM) Success
Time Frame: 24 months
Percent of subjects demonstrating maintenance or improvement in ROM at 24 months compared to baseline
24 months
Neurological Success
Time Frame: 24 months
Percent of patients demonstrating maintenance or improvement in combined motor and sensory evaluations at 24 months compared to baseline
24 months
ODI Success
Time Frame: 24 months
Percent of subjects demonstrating an improvement of greater than or equal to 15 points at 24 months compared to baseline
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS Success for Back and Leg Pain at Rest
Time Frame: 24 months
Number of patients demonstrating improvement in back and leg pain at 24 months compared to baseline
24 months
ODI Success Using Two Measures of Success
Time Frame: 24 months
Number of subjects demonstrating improvement in two measures of ODI success at 24 months compared to baseline
24 months
Improvement in SF-36 Scores
Time Frame: 24 months
Number of subjects demonstrating a greater than or equal to 15% improvement in mental (MCS) and physical (PCS) component summary scores at 24 months compared to baseline
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rolando Garcia, M.D., Orthopedic Care Center
  • Principal Investigator: James J Yue, M.D., Yale University
  • Principal Investigator: Dom Coric, M.D., Carolina Neurosurgery and Spine Associates
  • Principal Investigator: Steven Dennis, M.D., Hoag Memorial Hospital Presbyterian
  • Principal Investigator: Federico P. Girardi, M.D., Hospital for Special Surgery, New York
  • Principal Investigator: Mick Perez-Cruet, M.D., Michigan Head and Spine Institute
  • Principal Investigator: Harel Deutsch, M.D., Rush University Medical Center
  • Principal Investigator: Glenn Buttermann, M.D., Midwest Spine Institute
  • Principal Investigator: Dzung Dinh, M.D., Neuroscience Education and Research Foundation
  • Principal Investigator: Vikas Patel, M.D., University of Colorado, Denver
  • Principal Investigator: Christopher Ames, M.D., University of California, San Francisco
  • Principal Investigator: John Regan, M.D., St. John's Hospital and Health Center
  • Principal Investigator: Andrew Dailey, M.D., University of Utah Medical Center
  • Principal Investigator: Darren Bergey, M.D., Rancho Specialty Hospital
  • Principal Investigator: Brian Dalton, M.D., Hamot Medical Center
  • Principal Investigator: Scott Leary, M.D., Scripps Memorial Hospital La Jolla
  • Principal Investigator: David Hart, M.D., University Hospitals Cleveland
  • Principal Investigator: Antonio Castellvi, M.D., Foundatin for Orthopaedic Research and Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Actual)

December 7, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ASC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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