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

Degenerative Disc Disease Clinical Trial

Official title:

Clinical Study to Evaluate the Safety and Effectiveness of the Aesculap Activ-L™ Artificial Disc in the Treatment of Degenerative Disc Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00589797
• Other study ID #: ASC-01
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Est. completion date: January 2017

Study information

• Verified date: November 2018
• Source: Aesculap Implant Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: January 2017
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Diseases

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap Implant Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Success at 24 Months Relative to Baseline	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.	24 months
Primary	Device Success	Percent of subjects demonstrating no Subsequent Surgical Interventions (SSI's) at the index level (L4-L5 or L5-S1) at 24 months.	24 months
Primary	Absence of Serious Device Related Adverse Events	Percent of subjects demonstrating no device related SAE's at 24 months as per the Clinical Events Committee (CEC)	24 months
Primary	Range of Motion (ROM) Success	Percent of subjects demonstrating maintenance or improvement in ROM at 24 months compared to baseline	24 months
Primary	Neurological Success	Percent of patients demonstrating maintenance or improvement in combined motor and sensory evaluations at 24 months compared to baseline	24 months
Primary	ODI Success	Percent of subjects demonstrating an improvement of greater than or equal to 15 points at 24 months compared to baseline	24 months
Secondary	VAS Success for Back and Leg Pain at Rest	Number of patients demonstrating improvement in back and leg pain at 24 months compared to baseline	24 months
Secondary	ODI Success Using Two Measures of Success	Number of subjects demonstrating improvement in two measures of ODI success at 24 months compared to baseline	24 months
Secondary	Improvement in SF-36 Scores	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	24 months