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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aesculap Implant Systems
ClinicalTrials.gov Identifier:
NCT00589797
First received: December 26, 2007
Last updated: February 23, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Degenerative Disc Disease
Device: Activ-L Artificial Disc
Device: ProDisc Total Disc Replacement or Charite Atifical Disc
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Safety and Effectiveness of the Aesculap Activ-L™ Artificial Disc in the Treatment of Degenerative Disc Disease

Further study details as provided by Aesculap Implant Systems:

Primary Outcome Measures:
  • Overall success relative to baseline [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Measured by absence of treatment failure; absence or serious device related AE; maintenance or improvement of ROM at index level; maintenance or improvement inneurological status; improvement in ODI score.


Secondary Outcome Measures:
  • Back Pain, measured at rest using a visual analog scale (VAS); improvement of 20 mm or more on a 100 mm VAS scale at 24 months compared to baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 414
Study Start Date: January 2007
Estimated Study Completion Date: July 2017
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
Device: Activ-L Artificial Disc
Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
Active Comparator: 2
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
Device: ProDisc Total Disc Replacement or Charite Atifical Disc
Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589797

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

No publications provided by Aesculap Implant Systems

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aesculap Implant Systems
ClinicalTrials.gov Identifier: NCT00589797     History of Changes
Other Study ID Numbers: ASC-01
Study First Received: December 26, 2007
Last Updated: February 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Aesculap Implant Systems:
Degenerative
Disc

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 01, 2014