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Preclinical and clinical experience with a viscoelastic total disc replacement
Burkhard Rischke1, Raymond S Ross2, Boris A Jollenbeck3
1Center of Orthopaedic and Spine Surgery, Zurich, Switzerland.
SAS Journal
|March 25, 2015
Summary
The viscoelastic total disc replacement (VTDR) demonstrates excellent durability and clinical effectiveness for treating lumbar degenerative disc disease. This study confirms its ability to restore spinal stability and reduce pain.
Area of Science:
- Spine surgery
- Biomaterials
- Orthopedic biomechanics
Background:
- The human intervertebral disc is a complex viscoelastic structure crucial for spinal stability and motion.
- Degenerative disc disease necessitates treatments that restore disc height, angle, and viscoelastic properties.
- Existing disc replacements aim to mimic the natural disc's function.
Purpose of the Study:
- To evaluate the mechanical durability of a novel viscoelastic total disc replacement (VTDR).
- To assess the clinical and radiographic outcomes of VTDR in patients with lumbar degenerative disc disease.
- To determine if VTDR restores physiologic disc properties and spinal stability.
Main Methods:
- Mechanical fatigue testing to establish VTDR durability (50 million cycles).
- A 2-year prospective clinical trial involving 50 patients with single-level lumbar degenerative disc disease (L4-L5 or L5-S1).
- Clinical assessments included Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) for pain; radiographic analyses evaluated disc height and lordosis.
Main Results:
- VTDR exhibited durability exceeding 50 million cycles, equivalent to 50 years of use.
- Radiographic analysis confirmed restoration and maintenance of disc height and lumbar lordosis.
- Significant improvements observed: mean ODI decreased from 48% to 23%; mean VAS low-back pain decreased from 7.1 cm to 2.9 cm at 2 years.
Conclusions:
- The viscoelastic total disc replacement (VTDR) demonstrates excellent mechanical durability.
- VTDR effectively restores disc height, lordosis, and provides physiologic motion.
- The device shows significant clinical improvement in pain and function for degenerative disc disease.
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