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

NCT ID: NCT00589797

Last Updated: 2018-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2017-01-31

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.

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.

Conditions

Degenerative Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Investigational

Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.

Group Type: EXPERIMENTAL

Activ-L Artificial Disc

Intervention Type: DEVICE

Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.

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.

Group Type: ACTIVE_COMPARATOR

ProDisc-L Total Disc Replacement or Charité Artificial Disc

Intervention Type: DEVICE

Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.

Interventions

Activ-L Artificial Disc

Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.

Intervention Type: DEVICE

ProDisc-L Total Disc Replacement or Charité Artificial Disc

Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aesculap Implant Systems

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rolando Garcia, M.D.

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Care Center

James J Yue, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Dom Coric, M.D.

Role: PRINCIPAL_INVESTIGATOR

Carolina Neurosurgery and Spine Associates

Steven Dennis, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hoag Memorial Hospital Presbyterian

Federico P. Girardi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Mick Perez-Cruet, M.D.

Role: PRINCIPAL_INVESTIGATOR

Michigan Head and Spine Institute

Harel Deutsch, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Glenn Buttermann, M.D.

Role: PRINCIPAL_INVESTIGATOR

Midwest Spine Institute

Dzung Dinh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Neuroscience Education and Research Foundation

Vikas Patel, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Christopher Ames, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

John Regan, M.D.

Role: PRINCIPAL_INVESTIGATOR

St. John's Hospital and Health Center

Andrew Dailey, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah Medical Center

Darren Bergey, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rancho Specialty Hospital

Brian Dalton, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hamot Medical Center

Scott Leary, M.D.

Role: PRINCIPAL_INVESTIGATOR

Scripps Memorial Hospital La Jolla

David Hart, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland

Antonio Castellvi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Foundatin for Orthopaedic Research and Education

Locations

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

Countries

United States

References

Yue JJ, Mo FF. Clinical study to evaluate the safety and effectiveness of the Aesculap Activ-L artificial disc in the treatment of degenerative disc disease. BMC Surg. 2010 Apr 9;10:14. doi: 10.1186/1471-2482-10-14.

Reference Type: DERIVED

PMID: 20380708 (View on PubMed)

Other Identifiers

ASC-01

Identifier Type: -

Identifier Source: org_study_id