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

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ClinicalTrials.gov Identifier: NCT00589797
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Aesculap Implant Systems

Brief Summary:
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 or disease Intervention/treatment Phase
Degenerative Disc Disease Device: Activ-L Artificial Disc Device: ProDisc-L Total Disc Replacement or Charité Artificial Disc Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : January 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


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.
Device: Activ-L Artificial Disc
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.
Device: ProDisc-L Total Disc Replacement or Charité Artificial Disc
Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. Range of Motion (ROM) Success [ Time Frame: 24 months ]
    Percent of subjects demonstrating maintenance or improvement in ROM at 24 months compared to baseline

  5. 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

  6. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589797


Locations
Show Show 17 study locations
Sponsors and Collaborators
Aesculap Implant Systems
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aesculap Implant Systems
ClinicalTrials.gov Identifier: NCT00589797    
Other Study ID Numbers: ASC-01
First Posted: January 10, 2008    Key Record Dates
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Aesculap Implant Systems:
Degenerative
Disc
Additional relevant MeSH terms:
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Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases