Clinical trial NCT00589797: Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disc Disease
Keywords: Degenerative
Disc
Lead sponsor: Aesculap Implant Systems
Sponsor class: INDUSTRY
First posted: 2008-01-10
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Success at 24 Months Relative to Baseline
timeFrame: 24 months
measure: Device Success
timeFrame: 24 months
measure: Absence of Serious Device Related Adverse Events
timeFrame: 24 months
measure: Range of Motion (ROM) Success
timeFrame: 24 months
measure: Neurological Success
timeFrame: 24 months
measure: ODI Success
timeFrame: 24 months
Secondary outcomes:
measure: VAS Success for Back and Leg Pain at Rest
timeFrame: 24 months
measure: ODI Success Using Two Measures of Success
timeFrame: 24 months
measure: Improvement in SF-36 Scores
timeFrame: 24 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Memorial Hospital La Jolla
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Specialty Hospital
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Santa Monica
country: United States
facility: St. John's Hospital and Health Center
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine/New Haven Hospital
state: Connecticut
city: Aventura
country: United States
facility: Aventura Hospital and Medical Center
state: Florida
city: Tampa
country: United States
facility: University Community Hospital
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Peoria
country: United States
facility: Neurosciences Education and Research Foundation
state: Illinois
city: Maplewood
country: United States
facility: HealthEast St. John's Hospital
state: Minnesota
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Charlotte
country: United States
facility: Carolinas Healthcare
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Erie
country: United States
facility: Hamot Medical Center
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Orthopedic Care Center
name: Rolando Garcia, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: James J Yue, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolina Neurosurgery and Spine Associates
name: Dom Coric, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hoag Memorial Hospital Presbyterian
name: Steven Dennis, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Special Surgery, New York
name: Federico P. Girardi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan Head and Spine Institute
name: Mick Perez-Cruet, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Harel Deutsch, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Midwest Spine Institute
name: Glenn Buttermann, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Neuroscience Education and Research Foundation
name: Dzung Dinh, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Vikas Patel, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Christopher Ames, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. John's Hospital and Health Center
name: John Regan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah Medical Center
name: Andrew Dailey, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rancho Specialty Hospital
name: Darren Bergey, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamot Medical Center
name: Brian Dalton, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Memorial Hospital La Jolla
name: Scott Leary, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland
name: David Hart, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Foundatin for Orthopaedic Research and Education
name: Antonio Castellvi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.