Facet Joint Arthrosis, An Exclusion & Contraindication to Total Disc Arthroplasty
The following lists various authoritative sources specifying the inclusion/exclusion criteria for ADR with the Synthes Spine Inc. PRODISC®. In particular, every reference states specifically that facet joint disease (degeneration, arthrosis, arthropathy, osteophytes) is a contraindication. The reasoning is patently clear: If the facet joints are arthritic (and a pain generator), then expanding the disc space and increasing mobility will significantly exacerbate the pain condition, and furthermore accelerate the facet degeneration. Facet arthropathy is known to induce facet hypertrophy, and thus further stenosis. Furthermore, the Synthes labeling states that the remaining disc height should be 5mm or more. This prevents over-distraction damage to the nerve root, and also provides a margin of safety that there is not already significant facet Arthrosis due to a collapsed level.
- Synthes Spine: ”Radiographic confirmation of facet joint disease or degeneration.”
- Synthes Spine Surgical Technique: “Radiological confirmation of severe facet joint disease or degeneration”
- FDA: ”Radiographic confirmation of facet joint disease or degeneration.”
- Spine-Health.com: ”clinically significant degenerative facet disease”
- Dr. Kulkarni: ”Facet arthropathy has been appreciated as a major contraindication”
- Rudolf Bertagnoli et.al.: ”Care should be used to assess patients for the presence of facet arthropathy,”
- Rudolf Bertagnoli et. al: ”Patients should be screened carefully for evidence of facet joint impingement/degeneration”
- Delamarter et. al: ”severe facet degeneration were excluded from the study”
- Zigler et. al.: ”The authors identify factors leading to clinical failure, including posterior facet arthritis”
- Tropiano et. al: ”Exclusion criteria included facet Arthrosis”
- David Thierry: ”emphasized the importance of normal facet architecture.”
- Matthew Scott-Young: ”This is a failure of indication, in which the facet arthropathy is overlooked by the surgeon.”
- Le Huec, J.C.: ”This improvement is significantly correlated with facet arthrosis and muscle fatty degeneration.”
- M.E. Jansen: “pathology of the posterior elements. In such cases, fusion is still the first choice for treatment,”
- Balkan Cakir, et al: “The inclusion criteria … absence of facet joint arthrosis confirmed by CT, no pain relief after facet joint infiltration,”
- Michael Mayer et.al. “strict policy to before surgery rule out symptomatic facet joint involvement”
- John Regan: “Posterior facets should be carefully evaluated on physical exam and on the imaging studies such as MRI and CT scans. If posterior facet disease is suspected, diagnostic injection may be used to rule out this condition as the contributing source of pain as these patients do not benefit from total disc replacement.”
- Hochschuler, McAfee. “If .. factors (such as significant degenerative changes in the facet joint) are present, then the patient may have to undergo a revision surgery after the initial surgery
1.
Synthes Spine Inc. Prodisc Brochure
2. Synthes Spine Inc.
Surgical Technique
3. FDA.gov Trial
Specifications
5. Total disc
replacement—ProDisc
6. PRODISC® Total Disc
Replacement - Clinical Trials
7. Dr. Kulkarni: Prosthetic
Lumbar disc replacement for degenerative disc disease:
13. Dr. Patrick Tropiano:
Lumbar Total Disc Replacement. Seven to Eleven-Year Follow-Up
14. Dr. David Wong: Incidence
of Contraindications to Total Disc Arthroplasty:
15. Dr. David Thierry
Argospine News VIII: Interview
16. Spine-Health.com, Facet
Technologies
18. CMS, Centers for Medicare & Medicaid
Services
19. Meticulous patient selection
makes disc replacement safe, effective
20. Influence of facet and
posterior muscle degeneration on clinical results of lumbar total disc
replacement: two-year
follow-up.
21. Clinical results of
Maverick lumbar total disc replacement: two-year prospective follow-up.
22. Fusion versus disc
replacement for discogenic pain
24. Dynamic Stabilization of
the Lumbar Spine
25 MR imaging and CT in
osteoarthritis of the lumbar facet joints
28 Lumbar Total Disc Replacement:
Charité Artificial Disc ™
28. Issues To Consider Before
Having Artificial Disc Surgery
===============================================================
1. Synthes Spine Inc. Prodisc Brochure
Radiographic confirmation of facet joint disease or degeneration.
http://www.synthesprodisc.com/html/Prodisc-L.98.0.html (see Indications)
The remaining disc height should be 5 mm or more and the disc should not have major endplate irregularities.
Appearance of posterior osteophytes
===============================================================
2. Synthes
Spine Inc. Surgical Technique
Prodisc®-L. Modular intervertebral
disc prosthesis to stabilize the lumbar spine and restore the physiological
range of motion.
Contraindications.
– Spinal stenosis, radiculopathy
– Radiological confirmation of severe facet joint
disease or degeneration
- Bony Lumbar Spinal Stenosis ( may be caused by facet hypertrophy )
===============================================================
3. FDA.gov Trial Specifications
http://www.fda.gov/cdrh/pdf5/p050010c.pdf
Radiographic confirmation of facet joint disease or degeneration.
===============================================================
4. Dr Shedid et al. Lumbar total disc replacement compared with spinal
fusion: treatment choice and evaluation of outcome
http://www.nature.com/ncpneuro/journal/v1/n1/full/ncpneuro0018.html
Daniel Shedid, Kene T Ugokwe and Edward C Benzel, benzele@ccf.org
The
The indications for the CHARITÉ® artificial disc
include: one-level degenerative disc disease at L4–L5 or L5–S1, age between 18
and 60 years, and at least 6 months of failed conservative treatment.8,
9,
10
Patients with any of the following conditions should not undergo placement of
this disc: infection; spinal stenosis; spondylolisthesis; scoliosis; kyphosis;
facet joint disease; significant radiculopathy; osteoporosis, osteopenia
or other metabolic bone disease; previous back surgery (excluding discectomy, laminectomy and nucleolysis at the same level); multiple levels of degeneration;
autoimmune disorder; morbid obesity; or chronic steroid use.8,
10
===============================================================
5. Total disc replacement—ProDisc
http://www.spine-health.com/research/discupdate/artificial/artificial04.html
Exclusion criteria include more than two symptomatic diseased levels, known allergy to the implant components, prior lumbar fusion surgery, clinically compromised vertebral bodies from trauma, clinically significant degenerative facet disease, lytic spondylolisthesis or spinal stenosis, degenerative spondylolisthesis >Grade I, pain that defies diagnosis, osteoporosis, metabolic bone disease (including Paget's, osteomalacia), or small vertebral bodies.
===============================================================
6. PRODISC® Total Disc Replacement - Clinical
Trials
Information provided by Synthes,
Inc.
http://www.spineuniverse.com/displayarticle.php/article1678.html
No more than 2 vertebral levels may have DDD and all
diseased levels, either one or two, must be treated.
Known allergy to titanium, polyethylene,
cobalt, chromium or molybdenum.
Prior fusion surgery at any vertebral
level.
Clinically compromised vertebral bodies at
the affected level(s) due to current or past trauma.
Radiographic
confirmation of facet joint disease or degeneration.
Lytic spondylolisthesis or spinal stenosis.
Degenerative spondylolisthesis of grade > 1.
Back or leg pain of unknown etiology.
…
===============================================================
7. Dr. Kulkarni: Prosthetic Lumbar disc replacement for degenerative disc disease:
Arvind G. Kulkarni, Ashish
D. Diwan
Spine Service,
Department of Orthopaedic Surgery, St George Hospital
Campus, University of New South Wales, Sydney, Australia
https://tspace.library.utoronto.ca/bitstream/1807/7879/1/ni05156.pdf
The outcomes of total disc replacement on patients with mild facet arthrosis are inferior[10],[11],[12] and progression of facet arthrosis has been noticed in one series after total disc replacement.[12]
This phenomenon of disc incompetence (DDD) transfers the load to the facet joints which may lead to facet joint degeneration. …
Facet arthropathy has been appreciated as a major contraindication since pain from posterior elements may not be resolved by total disc replacement.
The outcomes of total disc replacement on patients with mild facet arthrosis are inferior[10-12] and progression of facet arthrosis has been noticed in one series after total disc replacement.[
Residual back and leg pain have been reported and could be a result of inappropriate patient selection or surgeon related factors.[11],[15],[22],[23],[25] These patients variably had pre-existent disc degeneration at other levels, facet arthrosis at the same level pre and post surgery, post-operative disc degeneration at adjacent levels, previous back surgeries in the form of nucleotomies, laminectomies etc.
10.Zeegers WS, Bohen LM, Laaper M, Verhaegen MJ. Artificial disc replacement with modular type SB Charite III: 2 year results in 50 prospectively studied patients. Eur Spine J 1999;8:210-7.
11.Bertagnoli R, Kumar S. Indications for full prosthetic disc arthroplasty: A coorelation of clinical outcome against a variety of indications. Eur Spine J 2002;11;131-6.
12.Lemaire
JP, Skalli W, Lavaste F, Templier A, Mendes F, Diop A, et
al. Intervertebral disc prosthesis: Results and
prospects for the year 2000. Clin Orthop
1997;337:64-76. 
[PUBMED] [FULLTEXT]
===============================================================
8. Rudolf Bertagnoli , MD
A Prospective Study With 2-Year Minimum Follow-up
Rudolf Bertagnoli, MD,* James J. Yue, MD,† Rahul V. Shah, MD,†
Conclusions. Our preliminary data on multisegmental ProDisc lumbar total disc arthroplasty appear to be a safe and efficacious treatment
method for debilitating lumbar spondylosis without significant facet arthropathy.
Exclusionary criteria included: patients with spinal stenosis,
osteoporosis, prior fusion surgery, chronic infections, metal allergies,
pregnancy, facet arthrosis,...
Care should be used to assess patients for the
presence of facet arthropathy,
Multisegmental ProDisc
lumbar total disc arthroplasty is a safe and
efficacious treatment method for debilitating lumbar spondylosis
without significant facet arthropathy.
Contraindications to multilevel disc arthroplasty
include obesity, osteoporosis, significant loss of articular facet cartilage,
===============================================================
9. Rudolf Bertagnoli , MD
a prospective study with 2-year minimum follow up, J Neurosurg Spine 4:91–97, 2006
RUDOLF BERTAGNOLI, M.D., JAMES J. YUE, M.D., ANDREA FENK-MAYER, M.D., JONATHAN
EERULKAR, M.D., AND JOHN W. EMERSON, PH.D.
Patients with radiographic evidence of circumferential spinal stenosis or facet joint
degeneration had been excluded.
Patients should be screened carefully for evidence of facet joint
impingement/degeneration,
Lumbar ADR has been proposed as an alternative to lumbar fusion in the
treatment of certain cases of lumbar spondylosis in
the absence of significant facet joint degeneration
Exclusionary criteria included the following: spinal stenosis,
osteoporosis, chronic infections, metal allergies, pregnancy, facet joint arthrosis, inadequate vertebral
endplate size, Workers’ compensation,
Surgery was performed after a complete radiographic/neuroimaging
assessment in all patients including AP lateral flexion–extension, lateral
bending radiography, CT,
and MR imaging. All patients underwent discography/CT
scanning to evaluate discogenic sources of
pain and the degree of facet joint degenerative changes.
Patients with evidence of intraarticular facet degeneration, specifically that
of joint space narrowing with or without cystic changes, were excluded from the
study. Patients in whom we observed
minimal extraarticular facet joint changes
(calcifications) were not excluded.
ADR appears to offer an effective option for those patients with
adjacent-segment degeneration in the setting of primarily axial back pain with
or without radicular symptoms, in the absence of facet joint degeneration.
We recommend strict adherence to traditional inclusion and exclusion criteria
for ADR and that all patients undergo CT scanning to assess for facet joint
degeneration. The presence of facet joint impingement secondary to
posterior fixation used for prior fusion should be excluded. The pain-inducing
hardware should be removed prior to ADR. If necessary, myelography
should be undertaken to exclude advanced cases of spinal stenosis.
Circumferential spinal stenosis present at the
adjacent-level segment should be considered a relative contraindication to ADR
because of the potential of decreasing the spinal canal volume as a result of
the lordotic enhancement.
(Interpretation: ADR typically creates a lordotics enhancement, which the authors here show will
decrease adjacent level spinal canal volume. This may lead to pain in the
sacrum ... due to the hyperlordosis and impingement of the spinal canal at
those levels.)
===============================================================
10. Rudolf Bertagnoli , MD
Bertagnoli R.
Presented at the Spine Arthroplasty
Society Global Symposium on Motion Preservation Technology. May 4-7,
2005.
http://www.orthosupersite.com/default.asp?page=view&rid=3728
Other contraindications included lytic spondylolisthesis, severe nondiscal central or severe lateral spinal canal stenosis associated with hypertrophic posterior facet joints, postoperative absence of posterior spinal elements following laminectomy and fascectomy, acute spinal fractures, tumors, spondylodiscitis and ventral approach-related problems, according to the abstract.
A combination of fusion and arthroplasty, so-called “hybrid constructs,” is a viable alternative, he said. If, for example, facet arthritis is too advanced or other conditions do not permit using the disc replacement, the combination can have very positive results.
===============================================================
11. Dr. Delamarter: ProDisc Artificial Total Lumbar Disc Replacement: Introduction and Early Results From the United States Clinical Trial: Dr. Rick Delamarter et. al.
SPINE Volume 28, Number 20S, pp S167–S175
Rick B. Delamarter, MD,
David M. Fribourg, MD, Linda E. A. Kanim, MA, and
Hyun Bae, MD
Patients with metal allergies, previous lumbar fusions, compromised vertebral
bodies, and severe facet degeneration were
excluded from the study.
The authors note that fair and poor clinical outcomes were found primarily in
patients with more severe, multilevel degenerative disease including facet arthritis.
all patients in this study have to meet strict
selection criteria (age 60, body mass index
40, absence of facet disease and spondylolisthesis, etc.) before qualifying for the study.
12. Dr. Jack Zigler: Lumbar spine arthroplasty
using the ProDisc II: Dr. Jack Zigler
Jack E. Zigler, MD*
The Spine Journal 4 (2004) 260S–267S
Exclusion criteria:
6. Facet joint degeneration
The authors identify factors leading to clinical failure, including posterior facet arthritis, osteoporosis, structural
deformities and secondary facet pain.
===============================================================
13. Dr. Patrick Tropiano: Lumbar Total Disc Replacement. Seven to
Eleven-Year Follow-Up
Patrick Tropiano,
Russel C. Huang, Federico P. Girardi,
Frank P. Cammisa, Jr. and Thierry Marnay
J Bone Joint Surg Am. 87:490-496, 2005.
doi:10.2106/JBJS.C.01345
Exclusion criteria included facet arthrosis,
central or lateral recess stenosis,
===============================================================
14. Dr. David Wong: Incidence of Contraindications to Total Disc Arthroplasty:
A
Retrospective Review of 100 Consecutive Fusion Patients with a Focused Analysis
of Facet Arthrosis
David A. Wong MD, MSc, FRCS, Betsy Annesser DPt, Tim Birney MD, Anant Kumar
MD, Roderick Lamond MD, FRCS, Stephen Johnson MD, Sanja Jatana MD, Gary Ghiselli MD
Presbyterian St. Lukes
Medical Center,
#1: Facet Joint Athritis
Facet arthrosis was documented on imaging reports or
operating room notes in 97/100. Reduced extension was present in 71/75 charts
that documented
The point where facet arthrosis definitely constitutes a contradiction to TDA will require analysis during long-term arthroplasty follow-up studies.
Suitable patients for TDA may not represent a significant cohort presently undergoing lumbar fusion.
===============================================================
15. Dr. David Thierry Argospine News VIII: Interview
http://www.argospine.org/pdf/argos-spinenews-viii.pdf
Dr. David provided his indications ... and also emphasized the importance of normal facet architecture.
===============================================================
16. Spine-Health.com, Facet Technologies
http://www.spine-health.com/research/discupdate/artificial/artificial06.html
Facet arthritis (degeneration of the facet joint) is currently a contraindication for any type of disc replacement. Proper spinal motion requires normal function of both the disc and facet joints.
===============================================================
17. Posterior
Dynamic Stabilization Devices in the Coming Age of Lumbar Disc Replacement:
Dr. Matthew Scott -Young
Dr.
http://www.medscape.com/viewarticle/555047_3 Posted 05/16/2007
In my experience during a decade of performing TDRs, postoperative instabilities occur for several reasons, and there are four possible scenarios. The first occurs as a result of facet arthropathy. This is a failure of indication, in which the facet arthropathy is overlooked by the surgeon.
Matthew_Scott_Young_InTouch3_06.pdf
The patient must be skeletally mature without any co-existing osteoporosis (i.e., 18 to
60 years old), facet arthrosis, or canal stenosis. Contra-indications
include but are not limited to spinal deformities or instability, facet hypertrophy, morbid obesity (BMI more than
30), sequestrated herniations or a significant
prolapse that causes cauda equina
syndrome.
===============================================================
18. CMS, Centers for Medicare & Medicaid Services
Proposed Decision Memo for Lumbar Artificial Disc Replacement (LADR) (CAG-00292R)
http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=170
===============================================================
19. Meticulous patient selection makes disc replacement safe, effective
http://www.orthosupersite.com/default.asp?page=view&rid=3265
By
ORTHOPAEDICS TODAY INTERNATIONAL 2005; 8:36
Scott-Young pointed out that surgeons should pay close attention to the facet joints. “[Facets] are very important biomechanically, but it is not a common and clear source of pain,” he said. Facet arthrography can be very useful in more fully identifying the pain source.
The main strategy for dealing with these complications, Bertagnoli said, is to avoid them. “Proper training and full understanding of the technology is mandatory for achieving good results,” he said.
(Dr. Bertagnoli is a primary instructor in the Synthes Surgeon Education Program, and as such receives consulting fees thereof.)
Bertagnoli said that some analyses have shown worldwide patient satisfaction with disc arthroplasty is around 93%.
(These 90%+ claims are only made by Dr. Bertagnoli and Dr. Thierry Marnay. Both have patents on the devices.)
Recent studies have found very low complication rates, Bertagnoli said. With more than 8000 implants of the Prodisc 2, the complication rate has been reported at less than 1%. “We know that 98% of complications are surgeon-related,” he said. “What were the reasons for these problems? No. 1 was the wrong indication. As pointed out before, indication and proper patient selection is really crucial.”
===============================================================
20. Influence of facet and posterior muscle
degeneration on clinical results of lumbar total disc
replacement: two-year follow-up.
Le Huec
JC, Basso Y, Aunoble S, et al.
J Spinal
Disord Tech 2005; 18: 219-223.
http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15905763&dopt=Abstract
Facet osteoarthritis grade 1 or 2 did not influence outcome (P = 0.82). On the other hand, muscle degeneration of grades 1 and 2 led to a better outcome than grades 3 and 4 (P = 0.006). CONCLUSIONS: This is the first study showing that a semiconstrained implant (Maverick) with a fixed posterior center of rotation can be implanted with grade 1 and 2 facet arthrosis with a good clinical outcome. This seems to confirm previous work showing that a posterior center of rotation lightens the load on the facets.
21. Clinical results of Maverick lumbar
total disc replacement: two-year prospective follow-up.
Le
Huec JC, et al.
The Oswestry score improved for 75% of patients. This improvement is significantly correlated with facet arthrosis and muscle fatty degeneration.
Orthop Clin North Am. 2005 Jul;36(3):315-22
===============================================================
22. Fusion versus disc replacement for discogenic pain
M.E.
Jansen, C. Lam, P. Pavlov, M. de Kleuver, M. Spruit & E. Vialle
Part II: Anterior interbody fusion
P. Pavlov, M. de Kleuver, M. Spruit, E. Vialle
Furthermore, even if disc replacement passes the test of
time, its indications would not be global, especially due to the distraction
needed for implanting the devices, and for patients with previous surgery or pathology of the posterior elements. In such cases, fusion is still the first choice for
treatment,
===============================================================
23. The Burton
http://www.burtonreport.com/infspine/SurgArtificialDiscEditorial.htm
Of further concern, is the letter to the Editors of the North American Spine Society <http://www.burtonreport.com/infspine/HistSpCareNASS.htm> publication /SpineLine/ by spine surgeon André van Ooij <http://www.burtonreport.com/PDF_Files/OoigLetEditorSpineLine2004.pdf>of the Netherlands, who has observed, in significant numbers of post-artificial disc implants that: "These patients represent the most disabled group of patients that I have personally have seen in 24 years of spine practice". Dr. Ooij also expressed concern regarding overload of the facet joints as a consequence of removal of the anterior longitudinal ligament and anulus fibrosis <http://www.burtonreport.com/infspine/SurgStabilCage.htm#Ant%20Long%20Lig%20&%20Anulus%20Fibrosis> producing axial rotational instability and related progressive degeneration of the facet joints. *
24. Dynamic Stabilization of the Lumbar
Spine
By
ORTHOPEDICS 2006; 29:716
http://www.orthosupersite.com/default.asp?page=view&rid=18592
Patient Selection
Total disk replacement. Patients were treated with total disk replacement for monosegmental symptomatic degenerative disk disease or postdiskectomy syndrome. The inclusion criteria were as follows: low back pain for at least 12 months, minimum 6 months of conservative therapy, absence of spondylolisthesis and spondylolysis confirmed by computed tomography (CT), absence of antero- or retrolisthesis confirmed by dynamic radiographs, absence of facet joint arthrosis confirmed by CT, no pain relief after facet joint infiltration, monosegmental disk degeneration confirmed by magnetic resonance imaging (MRI) (Figure 3A), absence of intraspinal scar tissue on MRI after postdiskectomy syndrome, and diskography with positive “memory pain”
25 MR imaging and CT in osteoarthritis of the lumbar facet joints
Dominik
Weishaupt1, Marco Zanetti1, Norbert Boos2, J.
Hodler1
1Department of Radiology, Orthopedic University
Hospital Balgrist, Forchstrasse
340, CH-8008 Zurich, Switzerland
2Department of Orthopedic Surgery, Orthopedic University Hospital Balgrist, Zurich, Switzerland
http://www.springerlink.com/content/00kp2b7evq84aek5/
Abstract
Objective. To test the agreement between MR imaging and CT in the assessment of osteoarthritis of the lumbar facet joints, and thus to provide data about the need for an additional CT scan in the presence of an MR examination. Design and patients. Using a four-point scale, two musculoskeletal radiologists independently graded the severity of osteoarthritis of 308 lumbar facet joints on axial T2-weighted and on sagittal T1- and T2-weighted turbo-spin-echo images and separately on the corresponding axial CT scans. Kappa statistics and percentage agreement were calculated. Results. The weighted kappa coefficients for MR imaging versus CT were 0.61 and 0.49 for readers 1 and 2, respectively. The weighted kappa coefficients for interobserver agreement were 0.41 for MR imaging and 0.60 for CT, respectively. There was agreement within one grade between MR and CT images in 95% of cases for reader 1, and in 97% of cases for reader 2. Conclusion. With regard to osteoarthritis of the lumbar facet joints there is moderate to good agreement between MR imaging and CT. When differences of one grade are disregarded agreement is even excellent. Therefore, in the presence of an MR examination CT is not required for the assessment of facet joint degeneration.
26. Die
Bandscheibenprothese
http://www.dr-gumpert.de/html/bandscheibenprothese.html info@dr-gumpert.de
Zu den
Kontraindikationen gehören:
Akuter Bandscheibenvorfall der Lendenwirbelsäule (unverhältnismäßige
Operation)
Osteoporose (Gefahr des Einbrechens der Bandscheibe in die
angrenzenden Wirbelkörper)
Höheres Alter (meistens zusätzlicher Verschleiß anderer Wirbelkörperstukturen,
oft schlechte Knochenqualität)
Wirbelkörpergleiten (Spondylolistesis
(Schmerzursache wird nicht behandelt))
Verschleiß der Wirbelgelenke (Spondylarthrose
(Schmerzursache wird nicht behandelt))
Wirbelkanalenge (Spinalkanalstenose
(Schmerzursache wird nicht behandelt))
27. Clinical Results of Total Lumbar Disc Replacement
With ProDisc II: Three-Year
Results for Different Indications
Christoph J. Siepe, MD; H. Michael Mayer, MD, PhD;
Karsten Wiechert, MD; Andreas Korge, MD
http://www.medscape.com/viewarticle/542479_1
All patients underwent fluoroscopically guided preoperative diagnostic injections to exclude facet joint and sacroiliac joint pain.
. Patients with significantly positive pain relief of >50% following these injections were excluded from this study and were not considered candidates for TDR.
We therefore feel reassured to continue our strict policy to before surgery rule out symptomatic facet joint involvement as well as osteoporosis, especially in older patients.
28 Lumbar Total Disc Replacement: Charité Artificial Disc ™
John J. Regan, M.D., Medical Director, Cedars-Sinai Institute for Spinal Disorders
Indications: Posterior facets should be carefully evaluated on physical exam and on the imaging studies such as MRI and CT scans. If posterior facet disease is suspected, diagnostic injection may be used to rule out this condition as the contributing source of pain as these patients do not benefit from total disc replacement.
29.
Epidemiology of indications and contraindications to total disc replacement in
an academic practice
The Spine Journal. Volume 7, Issue 4, Pages 387-512 (July-August 2007)
http://www3.aaos.org/education/anmeet/anmt2006/podium/podium.cfm?Pevent=107
Kingsley R. Chin MD
Department of Orthopaedics, Spine Surgery Service, 2 Silverstein, 3400 Spruce Street, University of Pennsylvania, Philadelphia, PA 19104, USA
John A. Glaser, MD, Charleston SC.
Patient sample
Six hundred twenty-seven consecutive symptomatic patients presenting to an
academic spine service.
Outcome measures
Presence of contraindications to lumbar TDR based on Food and Drug
Administration criteria.
Results
The incidence of indications for TDR was 0.5%
(3/627). The prevalence of no contraindications to TDR in the fusion Group 1
was 5% (3/57). Overall, 9% (3 fusion and 9 nonfusion) had no contraindications to TDR and the same
percentage satisfied indications for TDR. However, 96% (71/74) of Group 2
patients considered themselves satisfied with laminectomies
and laminotomies. The combined average number of
contraindications to TDR was 2 (SD, 1.33) (range, 0–6). For Group 1, it was 3
and 1 for Group 2 (p<.5).
Conclusions
Despite early enthusiasm for TDR replacing fusion, there was only a 0.5%
incidence of indications for TDR in the overall population and a 5% prevalence in the
fusion patients, but the majority were in young patients who
averaged about 38 years old. The absence of contraindications for TDR did not
equate to indications for TDR because other nonfusion
techniques exist. Based on the history of the introduction of other new spinal
technologies and the fact that the current criteria for TDR seems to result in
a relatively small number of eligible patients, there is risk of overuse of
this new technology.
28. Issues To Consider Before Having Artificial Disc Surgery
Stephan Hochschuler, M.D.,
Paul McAfee, M.D. 17 Nov 2004
http://www.spine-health.com/topics/surg/charite/charite03.html
"If the patient does have a painful disc, but other factors (such as significant degenerative changes in the facet joint) are present, then the patient may have to undergo a revision surgery after the initial surgery to either correct the placement of the disc or fuse the spine—a situation that is definitely best avoided by correctly assessing all the risk factors prior to the first surgery."