Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc Disease
Clinical Study to Evaluate the Safety and Effectiveness of the Aesculap Activ-L™ Artificial Disc in the Treatment of Degenerative Disc Disease
1 other identifier
interventional
376
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2007
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
December 7, 2018
CompletedDecember 7, 2018
November 1, 2018
5.9 years
December 26, 2007
January 27, 2016
November 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
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
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
Range of Motion (ROM) Success
Percent of subjects demonstrating maintenance or improvement in ROM at 24 months compared to baseline
24 months
Neurological Success
Percent of patients demonstrating maintenance or improvement in combined motor and sensory evaluations at 24 months compared to baseline
24 months
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 Outcomes (3)
VAS Success for Back and Leg Pain at Rest
24 months
ODI Success Using Two Measures of Success
24 months
Improvement in SF-36 Scores
24 months
Study Arms (2)
Investigational
EXPERIMENTALImplantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
Control
ACTIVE COMPARATORImplantation 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.
Interventions
Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
Eligibility Criteria
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.
- +2 more criteria
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.
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Scripps Memorial Hospital La Jolla
La Jolla, California, 92037, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658, United States
Rancho Specialty Hospital
Rancho Cucamonga, California, 91730, United States
University of California San Francisco
San Francisco, California, 94143, United States
St. John's Hospital and Health Center
Santa Monica, California, 90404, United States
University of Colorado Health Sciences Center
Aurora, Colorado, 80045, United States
Yale University School of Medicine/New Haven Hospital
New Haven, Connecticut, 06520, United States
Aventura Hospital and Medical Center
Aventura, Florida, 33180, United States
University Community Hospital
Tampa, Florida, 33613, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Neurosciences Education and Research Foundation
Peoria, Illinois, 61605, United States
HealthEast St. John's Hospital
Maplewood, Minnesota, 55109, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Carolinas Healthcare
Charlotte, North Carolina, 28203, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Hamot Medical Center
Erie, Pennsylvania, 16507, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Related Publications (1)
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.
PMID: 20380708DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director of Medical and Scientific Affairs
- Organization
- Aesculap Inc.
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 10, 2008
Study Start
January 1, 2007
Primary Completion
December 1, 2012
Study Completion
January 1, 2017
Last Updated
December 7, 2018
Results First Posted
December 7, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share