CHARITÉ Versus ProDisc: A Comparative Study of a Minimum 3-Year Follow-up

Study Design. A retrospective study. Objectives. To evaluate and compare clinical and radiologic outcomes of the CHARITÉ and ProDisc. Summary of Background Data. There is no clinical report comparing CHARITÉ and ProDisc. Methods. Among a total of 61 patients who underwent total disc replacement, 57 patients followed more than 3 years were enrolled. The CHARITÉ was used in 33 patients and ProDisc in 24. MRI follow-up was possible in 52 patients. Clinical and radiologic data including range of motion (ROM) and facet degeneration of the replaced segment, and degeneration of the disc at the adjacent level were evaluated. Results. Mean percentage improvement of Oswestry Disability Index (ODI) score was 78.9% in the CHARITÉ group and 75.8% in ProDisc group. The mean improvement of the Visual Analogue Scale (VAS) pain score was 72% in the CHARITÉ and 74.2% in ProDisc. There was no statistical difference between 2 groups in improvement rates either of the ODI scores and VAS scores. Degradation of the facets was seen in 36.4% of the CHARITÉ and 32% of the ProDisc. Degradation of disc degeneration at the adjacent level above the index level was seen in 19.4% in the CHARITÉ and 28.6% in the ProDisc. The degradation rates of facet joints and disc at adjacent segment between the 2 groups were not significantly different. Segmental ROM of the replaced segments was well preserved, but ROM of L5–S1 of the ProDisc was significantly less than that of the CHARITÉ. Conclusions. While clinical outcomes of both CHARITÉ and ProDisc groups were fairly good, the facet joint of the index level and the disc at the adjacent level showed an aggravation of the degenerative process in a significant number of patients, regardless of the device used, raising concerns of possible late consequences of total disc replacement, especially regarding facet arthrosis and adjacent segment disease.

[1]  G B Andersson,et al.  The Effect of Disc Degeneration and Facet Joint Osteoarthritis on the Segmental Flexibility of the Lumbar Spine , 2000, Spine.

[2]  J. Stieber,et al.  Early failure of lumbar disc replacement: case report and review of the literature. , 2006, Journal of spinal disorders & techniques.

[3]  Rolando Garcia,et al.  A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemptions Study of Lumbar Total Disc Replacement With the CHARITÉ™ Artificial Disc Versus Lumbar Fusion: Part I: Evaluation of Clinical Outcomes , 2005, Spine.

[4]  S. Blumenthal,et al.  Artificial disc: preliminary results of a prospective study in the United States , 2002, European Spine Journal.

[5]  Jeffrey C. Wang,et al.  L5–S1 Segment Survivorship and Clinical Outcome Analysis After L4–L5 Isolated Fusion , 2003, Spine.

[6]  J. Le Huec,et al.  Influence of Facet and Posterior Muscle Degeneration on Clinical Results of Lumbar Total Disc Replacement: Two-Year Follow-Up , 2005, Journal of spinal disorders & techniques.

[7]  M. Rahm,et al.  Adjacent-segment degeneration after lumbar fusion with instrumentation: a retrospective study. , 1996, Journal of spinal disorders.

[8]  Bryan W Cunningham,et al.  SB Charité disc replacement: report of 60 prospective randomized cases in a US center. , 2003, Journal of spinal disorders & techniques.

[9]  D. Ohnmeiss,et al.  Lumbar Spine Arthroplasty: Early Results Using the ProDisc II: A Prospective Randomized Trial of Arthroplasty Versus Fusion , 2003, Journal of spinal disorders & techniques.

[10]  Hyun Bae,et al.  ProDisc Artificial Total Lumbar Disc Replacement: Introduction and Early Results From the United States Clinical Trial , 2003, Spine.

[11]  CASEY K. LEE,et al.  Accelerated Degeneration of the Segment Adjacent to a Lumbar Fusion , 1988, Spine.

[12]  The Implications of Constraint in Lumbar Total Disc Replacement , 2003, Journal of spinal disorders & techniques.

[13]  T. Marnay.  4:19 Lumbar disc replacement , 2002 .

[14]  C. Pfirrmann,et al.  Magnetic Resonance Classification of Lumbar Intervertebral Disc Degeneration , 2001, Spine.

[15]  Elizabeth A. Krupinski,et al.  Oblique Reformation in Cervical Spine Computed Tomography: A New Look at an Old Friend , 2003, Spine.

[16]  François Lavaste,et al.  Clinical and Radiological Outcomes With the Charité™ Artificial Disc: A 10-Year Minimum Follow-Up , 2005, Journal of spinal disorders & techniques.

[17]  S. L. Griffith,et al.  A Multicenter Retrospective Study of the Clinical Results of the LINK®SB CharitéA Intervertebral Prosthesis. The Initial European Experience , 1994, Spine.

[18]  Patrick Tropiano,et al.  Correlation Between Range of Motion and Outcome After Lumbar Total Disc Replacement: 8.6-Year Follow-up , 2005, Spine.

[19]  A. Korge,et al.  Minimally invasive total disc replacement: surgical technique and preliminary clinical results , 2002, European Spine Journal.

[20]  R. Bertagnoli,et al.  Indications for full prosthetic disc arthroplasty: a correlation of clinical outcome against a variety of indications , 2002, European Spine Journal.

[21]  F. Oner,et al.  Complications of Artificial Disc Replacement: A Report of 27 Patients with the SB Charité Disc , 2003, Journal of spinal disorders & techniques.

[22]  D. Harrison,et al.  Increasing age does not affect good outcome after lumbar disc replacement , 2000, International Orthopaedics.

[23]  Bryan W Cunningham,et al.  Prospective randomized study of the Charite artificial disc: data from two investigational centers. , 2004, The spine journal : official journal of the North American Spine Society.

[24]  Patrick Tropiano,et al.  Long-Term Flexion-Extension Range of Motion of the Prodisc Total Disc Replacement , 2003, Journal of spinal disorders & techniques.

[25]  F. Postacchini,et al.  Results of Disc Prosthesis After a Minimum Follow‐Up Period of 2 Years , 1996, Spine.

[26]  Paul Park,et al.  Adjacent Segment Disease after Lumbar or Lumbosacral Fusion: Review of the Literature , 2004, Spine.

[27]  Samuli Ripatti,et al.  Determinants of the Progression in Lumbar Degeneration: A 5-Year Follow-up Study of Adult Male Monozygotic Twins , 2006, Spine.

[28]  J. Zigler,et al.  Lumbar spine arthroplasty using the ProDisc II. , 2004, The spine journal : official journal of the North American Spine Society.

[29]  D. Ohnmeiss,et al.  Lumbar Spine Arthroplasty: Early Results Using the ProDisc II: A Prospective Randomized Trial of Arthroplasty Versus Fusion , 2003, Journal of spinal disorders & techniques.

[30]  A. Studer.  Nucleus prosthesis: a new concept , 2002, European Spine Journal.

[31]  Seungcheol Lee,et al.  Vertical split fracture of the vertebral body following total disc replacement using ProDisc: report of two cases. , 2005, Journal of spinal disorders & techniques.

[32]  Helmut D. Link,et al.  History, design and biomechanics of the LINK SB Charité artificial disc , 2002, European Spine Journal.

[33]  F. Girardi,et al.  Lumbar Disc Replacement: Preliminary Results with ProDisc II After a Minimum Follow-Up Period of 1 Year , 2003, Journal of spinal disorders & techniques.

[34]  S. Blumenthal,et al.  Prospective Study Evaluating Total Disc Replacement: Preliminary Results , 2003, Journal of spinal disorders & techniques.

[35]  T. David.  Complications With the SB Charité™ Artificial Disc , 2003 .

[36]  W. S. Zeegers,et al.  Artificial disc replacement with the modular type SB Charité III: 2-year results in 50 prospectively studied patients , 1999, European Spine Journal.

[37]  W. Skalli,et al.  Intervertebral Disc Prosthesis: Results and Prospects for the Year 2000 , 1997, Clinical orthopaedics and related research.