activ® L
Lumbar disc prosthesis
activ® L is the lumbar disc prosthesis for the motion preserving treatment of degenerative disc disease of the lumbar spine. The main objectives of the treatment is a fast pain reduction and the preservation/restoration of segmental function and motion. The specific design of activ® L allows the protection of the adjacent level. The unique translational movement of activ® L is designed to minimize biomechanical stress at the facet joints and to avoid facet joint arthrosis in a medium- and long-term prospect.
Advantages
- Unique translational movement to avoid biomechanical stress at the facet joint
- Unique translational movement for an effective protection of the the adjacent disc levels
- Anterior and antero-lateral approach possible
- Specific instrumentation for the antero-lateral approach
- Design of prosthesis plates adapted to the anatomy of vertebral body endplates
- Unique PE-Material (Inlay) to reduce wear rate to 12-17% of other lumbar prosthesis types
- Specific prosthesis design treatement of L5-S1
- Plasmapore® coating for a fast and safe bony integration of the prosthesis plates to the vertebral body endplates
- Spikes and/or Keels as primary stability structures. Can be used together in any combination.
Features
- Unique translational movement
- Convex prosthesis plates
- Anatomical adapted footprint
- Differentiated implant design for L5-S1
- Spikes and/or Keel
- Plamapore® coating
- Specific PE material for the Inlay
- Smallest height with 8.5 mm
- Instrumentation for the lateral approach
- Free choice of direction of approach (angulation)
- Revision instruments
Scientific Studies
Biotribological evaluation of artificial disc arthroplasty devices: Influence of loading and kinematic patterns during in vitro wear simulation; Thomas M. Grupp, James J. Yue, Rolando Garcia Jr., Janet Basson, Jens Schwiesau, Bernhard Fritz, Wilhelm Blömer; Eur Spine J (2009) 18:98-108
Analysis of Spinal Kinematics Following Implantation of Lumbar Spine Disc Prostheses versus Fusion: Radiological Study; A. Nabhan, B. Ishak, A. Al Hary, W. I. Steudel, O. Kollmar, O. Steimer; Journal of Long-Term Eff ects of Medical Implants, 17(3): 107-113 (2007)
Lumbar Total Disk Arthroplasty – Design and Technique Considerations for the Next-Generation Implant; James J. Yue, Rolando Garcia; Backup 2-2005, Springer
Initial Clinical Results of the activ® L Lumbar Total Disc Replacement (TDR) Prosthesis: A Prospective Study with 1 year follow-up; Dirk Brücher, Christof Müller, Rolando Garcia, James J. Yue; Abstract/Poster on SAS 2007
Early Clinical and Radiographic Outcome with the activ® L Total Disc Replacement: Data from Two Centers in the US IDE Trial; Garcia Rolando, Yue James J.; Abstract/Poster on SAS 2008
Clinical Evaluation of a New Lumbar Artificial Disc (activ® L); S. Sola, R.Hebecker, S. Mann, J. Piek; Abstract/Poster SAS 2008
Prospective Randomized US Trial Comparing an Unconstrained, Semi-constrained, and Constrained TDR in the Treatment of Single Level Discogenic Pain: Radiograhic Results from 2 Centers in an FDA IDE Study; Garcia R., Yue J.J.; Abstract/Oral Presentation SAS 2009
Volumetric Analysis of Foraminal Parameters Following Lumbar Total Disc Replacement: A Radiographic and Clinical Comparison of 3 Biomechanical Types of Lumbar Disc Replacements: A Semi-Constrained Device, A Controlled Translation Device (CTD) and An Unconstrained Device; Yue J.J., Garcia R., Morreale J.M.; Abstract/Oral Presentation SAS 2009
Intercontinental Differences in Surgeon’s Preferences: North American versus European Surgeon Differences in Choice of Primary Endplate Fixation, Implant Size, Lordosis and Height; Rolando Garcia Jr MD, James Y Yue MD, Wolfgang Daiber; Abstract/Poster SAS 2009
Indication
Motion preserving total disc replacement (TDR)/disc arthroplasty in case of:
Degenerative Disc Disease (DDD) with leg and/or back pain and/or neurological deficits in legs and/or feet with or without disc herniation.
Lumbar discopathy and / or black disc syndrome.
Monosegmental or bisegmental disc degeneration between L3-S1.
Without significant degeneration of the facet joints.
Without significant instability.
Preoperative disc height of at least 3-4 mm.