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

Completed · Not applicable

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT00589797

Run by

Aesculap Implant Systems

People needed

376

Starts

2007-01-01

Expected to finish

2017-01-01

Last updated by the study team

2018-12-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Scripps Memorial Hospital La Jolla — La Jolla, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Rancho Specialty Hospital — Rancho Cucamonga, California, United States
• University of California San Francisco — San Francisco, California, United States
• St. John's Hospital and Health Center — Santa Monica, California, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Yale University School of Medicine/New Haven Hospital — New Haven, Connecticut, United States
• Aventura Hospital and Medical Center — Aventura, Florida, United States
• University Community Hospital — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Neurosciences Education and Research Foundation — Peoria, Illinois, United States
• HealthEast St. John's Hospital — Maplewood, Minnesota, United States
• Hospital for Special Surgery — New York, New York, United States
• Carolinas Healthcare — Charlotte, North Carolina, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Hamot Medical Center — Erie, Pennsylvania, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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