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CHAPTER 40

Lumbar Disc Replacement: Current Model, Results, and the Future

Robert D. Fraser
More than 100 different designs for a disc prosthesis hav e been patented or described in publications (1) since F ern­strom first replaced the nucleus with a metal bearing ball in the late 1950s (2). Very few of these devices have been used clinically, however, reflecting the difficulty of trans­lating the success of hip and knee arthroplasty to the spine. The prostheses that ha v e been implanted in humans can be classified as (a) nucleus devices or spacers, (b) mechanical devices with moving parts, and (c) elas­tomeric implants that aim to reconstruct the normal elas­tic properties of the disc.
NUCLEUS PROSTHESES
The nucleus replacement device used most extensively in humans is the Prosthetic Disc Nucleus, or PDN (Raymedica, Minneapolis, MN). This consists of a h ydro­gel pellet contained within a woven polyethylene jacket. The hydrophilic properties of hydrogel provide this device with the capacity to absorb fluid and expand. Hydrogel is a copolymer of polyacrylonitrile (non­hydrophilic) and polyacrylamide (hydrophilic); the abil­ity to absorb and bind water is determined by the ratio of these polymers. The current design per mits the pellets to absorb 80% of their weight in water, giving the PDN device the potential to restore or maintain disc height. The aim of the woven polyethylene jacket is to limit swelling and to minimize horizontal spreading (3).
The recommended technique involves the coronal placement of two parallel devices within the enucleated disc space, either by the posterior (hemilaminotomy) or lateral (transpsoas) routes. The developers state that this device is not intended for use in cases of severe disc degeneration or where end plate defects are present (3).
Initial trials during the mid-1990s, with two implants placed side by side in a sagittal plane, demonstrated a high expulsion rate with 38% of subjects requiring revi-
sion (4). The PDN shape and surgical protocol were sub­sequently modified to minimize the extrusion rate, and further clinical trials are in progress. Encouraging results are claimed with the use of PDN (3–5), although in each paper details of the methodology are insufficient to per­mit critical review.
Other nuclear replacements implanted clinically include the Aquarelle (Stryker Howmedica, Mahwah, NJ), a poly­vinyl alcohol material and the Newcleus (Sulzer Spine­Tech, Edina, MN), a polycarbonate urethane elastomer, but to date there are no published results of these devices.
Nucleus prostheses may be inserted through a rela­tively minimally invasive or potentially percutaneous approach. While this increases the appeal of the proce­dure, nucleus replacement does not address pathology related to the annulus or end plate, both of which may be important components of a painful degenerative process. Furthermore, nucleus devices are intended to work in conjunction with the annulus to restore the biomechani­cal function of the disc. To insert such a device, an annu­lus lesion must either be made or already exist. Although special dilators to minimize annulus damage have been used for the phase IV trials of the PDN, it is unclear whether the benefits of nucleus replacement will out­weigh the effects of damage caused to the annulus.
MECHANICAL DISC PROSTHESES
The prime aim of mechanical disc replacement is to restore the normal kinematics of the motion segment. The designs of two mechanical disc prostheses tested in clin­ical trials are based on the principle of low-friction poly­ethylene on metal articulations developed for total hip and knee arthroplasty. A third device, similarly designed on the basis of the success of prostheses developed for large synovial joints but with a metal/metal (chrome cobalt) interface and a posterior rotation axis, is being
393
394 /SECTION V/SPECIFIC CLINICAL ENTITIES
tested in a multicenter clinical trial (6). In general these prostheses are intended to replace almost the entire disc, are inserted using an approach similar to an anterior lum­bar interbody fusion, and rely on large spikes or fins plus bony ingrowth for stability against the vertebral end plates. Mechanical artificial discs lack elasticity and can­not replicate the normal compressive stiffness of the nat­ural disc. Instead they depend on the restoration of a mobile lordosis to absorb compressive loads across the lumbar spine (7). Moreover their articulating surfaces provide little resistance to torsion, a function of the motion segment that is impaired by the necessary removal of most of the annulus.
Schellnack and Buttner-Janz were responsible for the development of the first version of the Link SB Charité (Waldemar Link GmbH & Co., Hamburg) artif icial disc in 1982 (8). Over the next five years there were two re­visions of the design. Consisting of a biconvex poly­ethylene spacer articulating with two concave cobalt­chromium alloy end plates, the prosthesis allows rotation in all three planes. Changing centers of rotation are allowed by the sliding of the polyeth ylene core, similar to that which is achieved in mobile-bearing total knee replacements. First implanted in 1987, the latest model of the Link SB Charité has been used more extensively than any other disc prosthesis. Approximately 4,000 prosthe­ses have been implanted (7); the report from the largest case series of 105 patients describes a satisfactory out­come with the procedure (8).
The ProDisc (Spine Solutions, New York, NY) was first described by Marnay in 1991 (9). It consists of a polyethylene cap articulating with two titanium alloy end plates. The cap over cup design of the metal-polyethyl­ene-metal articulation permits motion in all three planes. Bertagnoli and Kumar reported on a series of 108 patients with follow-up ranging between 3 months to 2 years (10). In this, the only published paper on the out­come with the ProDisc, an overall success rate of 90.8% was claimed, increasing to 98% in patients considered to have “prime” indications.
ELASTOMERIC DISC PROSTHESES
The attraction of elastomeric discs is their potential to replicate the elasticity of the normal human disc. Not only would it be feasible to restore the normal compres­sive stiffness of the natural disc, but also if f irm attach­ments to the bony end plates could be achieved, it would provide resistance to torsion and shear.
With these goals in mind, Steffee designed the Acro­Flex (DePuy, Acromed Corporation, Cleveland, OH) arti­ficial disc using a polyolef in-based rubber core vulcan­ized between two titanium end plates. Not only did the rubber core provide range of motion, but it also enabled replication of normal disc elasticity . In theory, this design
should allow for better absorption of loads. However, this advantage of elastomers is offset b y their potentially infe­rior wear characteristics as demonstrated by the relatively high rates of failure. In the original series of six patients, two were reported as failures due to debonding of the rubber core (11). A second-generation device, using a sil­icone core instead of rubber, was implanted in eight patients with one mechanical failure. All failures oc­curred at levels with increased stress, either due to adja­cent fusion levels or scoliosis. The AcroFlex is now in its third generation of design, reverting back to the rubber core optimized with improved processing and bonding techniques, and refined indications for surgery. Although functional outcomes following implantation have been generally satisfactory, further trials with the third genera­tion prosthesis were abandoned with the detection of early failure of the rubber core on thin-section computed tomography (CT) scans (12).
The thin-section CT scans used in the AcroFlex study also identified a significant number of patients with periprosthetic heterotopic ossification. Limiting range of motion may be another potential source of failure for any disc replacement. It is therefore recommended that future studies include the use of thin-section CT and relate this to range of motion on standing flexion and extension radiographs.
BASIS FOR CURRENT INDICATIONS
For any spinal operation, including total disc arthro­plasty, patient selection should be based on a careful con­sideration of many factors. A successful outcome is more likely to be achieved with the precise correlation of the patient’s histor y, physical examination, and radiographic investigations, in conjunction with psychosocial and medical backgrounds. Bearing this in mind, indications were developed for a trial of the AcroFlex lumbar disc prosthesis (12). Only patients with one- or two-level symptomatic disc degeneration at either L4-5 or L5-S1 were included. Patients had to complain of disabling low back pain, with or without referral type leg symptoms that had been present for a minimum of 12 months and had failed to respond to nonoperative treatment. Further­more, the symptomatic degenerative level had to be con­vincingly localized by provocative discography. For inclusion in the study discography had to demonstrate (a) internal disc disruption at the target level, (b) reproduc­tion of the patient’s typical pain at the target level, and (c) failure to reproduce typical pain at the control levels adja­cent to the target level. Because of uncertainty about the long-term results only patients between the ages of 30 and 55 were considered (12).
The contraindications to disc replacement surgery are made up of technical and patient selection considerations. Patients should be excluded if there is a history of previ-
CHAPTER 40/LUMBAR DISC REPLACEMENT / 395
ous lumbar infection or an active infection elsewhere. Because disc replacement surgery does not address posterior element pathology, patients with spondylitic spondylolisthesis, significant facet arthritis, lateral recess stenosis, or central stenosis should be considered unsuit­able. Technical considerations that impede or prevent disc arthroplasty include patients with a steep lumbosacral angle at the target level, osteopenia, previous abdominal radiation or vascular graft, and morbid abdominal obe­sity. Lastly, patient factors such as significant medical comorbidity, ongoing litigation or compensation issues, substance abuse, presence of three or more Waddell behavioral signs (13), or psychiatric illness may be the major factors influencing eventual outcomes. The pres­ence of any of these factors should be regarded a con­traindication to disc replacement surgery.
Despite the suggestion that in time disc replacement will be a solution for multilevel degeneration or degen­eration adjacent to a fused segment, this has not been considered an ideal indication. Additionally, given the increased stresses placed on the prosthesis in a patient with structural scoliosis or adjacent-level fusion, such conditions are considered relative contraindications.
Bertagnoli and Kumar tried to correlate preoperative clinical findings to outcome with a view to formulating appropriate indications for disc replacement (10). They conducted a retrospective review of 108 patients who underwent total disc arthroplasty with the ProDisc pros­thesis. The patients were separated into accordingly into four groups, those who were considered to have “prime”, “good”, “borderline”, or “poor” indications for surgery. Patients with a “prime” indication had a disc height greater than 4 mm, absence of facet joint arthritis, no adjacent-level degeneration, and intact posterior ele­ments. Patients with adjacent-level fusions were con­sidered to have “borderline” indications. While there appears to be a gradient of improved successful outcomes in patients with better indications, no statistical analyses were performed. How e v er , it also seems that patients with “better indications” were those with minimal degenera­tion and they may well have achieved better outcomes no matter what form of treatment was employed.
REPORTED CLINICAL RESULTS
In a critical assessment of the evidence related to lum­bar disc replacement, Wai et al. (14) carried out a thor­ough search of both the Pubmed and Ovid Medline databases up to October 2002, and identified papers con­cerned with the current clinical use of disc prostheses. Their assessment, summarized in Table 40-1, recorded factors important to the outcome of disc replacement, namely: (a) restoration of disc function, (b) preservation of adjacent levels, (c) overall clinical function, and (d) complications. The follow-up for all papers reviewed
averaged just less than 2 years with the conclusions often based on patients followed up for a much shorter period.
Although a follow-up of 2 years is generally consid­ered acceptable for publishing surgical results, it is quite inadequate when assessing the outcome of disc replace­ment surgery. This is particularly the case when assessing the safety of implants used for total disc replacement. Their large dimensions and location close to major ves­sels makes anterior low-lumbar revision surgery haz­ardous, particularly when this is performed for complica­tions related to mechanical failure.
In their critical review, Wai et al. (14) found a wide dis­crepancy in the definitions of clinical outcome, many of which were poorly def ined, with reported success rates ranging from 63% to 95% after disc replacement. Over­all, these results are similar to those from case series reports for spinal fusion (15–21), and for common forms of nonoperative care (22–26). Certainly, randomized con­trolled trials, using validated and independent assess­ments of outcome and safety are necessary to establish the efficacy of disc replacement compared with the cur­rent standard of care. Clearly, because of the large influ­ence on function of factors other than disc pathology, a major effect from disc replacement would be needed to reach statistically significant differences. The Swedish Lumbar Spine Study Group published a report of a ran­domized controlled trial on fusion for back pain (15). From the published data, Wai et al. (14) estimated that more than 500 subjects would be needed to determine a 10% improvement in outcome for a 2:1 study design with a power of 0.8.
Even though there may be no significant difference in clinical outcomes between fusion and disc replacement in the short term, the latter has the theoretical advantage of restoring the function of the motion segment, hence pro­tecting the adjacent levels. Almost all of the published studies have described restoration of disc height and return of motion for both nuclear and total disc replace­ment surgeries (14). Although protection of adjacent disc levels is considered of prime importance to the rationale for disc replacement, only three studies hav e assessed this potential benefit. Cinotti et al. perfor med magnetic reso­nance imaging (MRI) on 10 patients from their original cohort of Link SB Charité III prostheses and found no adjacent level degeneration (27). As more than 75% of their study population has not been assessed, it is not valid to draw any conclusions from their report. In the report of their experience with the ProDisc, Bertagnoli and Kumar mention that 4.6% of patients dev eloped radi­ographic evidence of adjacent-level degeneration within 3 to 24 months of implantation (10). With such a short follow-up and without a control group, it is unclear if this represents the natural history of disc degeneration or is significantly less than would have occurred had the pa­tients undergone a lumbar fusion. Many investigations of
failure
in back pain dislocation; 1% core
eventual fusion
on MRI for excellent, 17% ROM affected if
10 patients required malpositioned
>50% (1 subsidence,
restoration of 2 ossification)
disc height
and lordosis
fair results
technical adjacent level fusion
radiographic OR
result
level
degeneration
medication
lordosis by 7° in pain
in Oswestry
b
avg. of 1.8 mm scores reported in
reported in 7 patients
7 patients
VQ Increase in disc N/A 43.7% improvement 10% overall explant rate
a
size follow-up
Sample Months of
TABLE 40-1. Summar y of published peer-reviewed clinical papers on disc replacement arthroplasty
(no. of (range Study Restoration of Preservation of Clinical
Author/year Disc discs) if stated) quality normal mechanics adjacent levels success Complications
Enker, 1993 Acroflex 6 40 8° avg. ROM N/A 66% success 33% implant failure
Griffith, 1994 Char ité SB III 93 (139) 12 (1–37) N/A N/A 65% improvement 4.3% migration/
III trials disc height for migration
Cinotti, 1996 Char ité SB III 46 (56) 38 (48–60) IR, NC 12° avg. ROM No degeneration 63% good or 26% placed too anterior;
Lemaire, 1997 Charité SB III 105 51 NC 7° avg. ROM, N/A 79% excellent 2.9% related to implant
Zeegers, 1999 Charité SB III 46 (75) 48 NC 74% good 24% required 70% improved 1 required conversion to
Sott, 2000 Charité SB III 15 48 (18–68) NC N/A N/A 80% good or None related to implant
Bertagnoli, 2002 ProDisc 108 (134) (3–48) VQ, NC 10° avg. ROM 4.6% adjacent 90.8% excellent None related to implant
Hopf, 2002 Charité SB III 35 15 NC Correction of avg. N/A 80% reduction None related to implant
Bertagnoli, 2002 PDN—phase 168 6 (3–24) VQ Preservation of N/A 88% success 26% required revision
Hochshuler, 2002 Charité SB III 22 12 VQ N/A N/A 40% improvement None related to implant
phases height by an of Oswestry
Klara, 2002 PDN—all 423 Up to 48
IR, reported that outcomes assessed independently; MRI, magnetic resonance imaging; NC, no conflict
Buttner-Janz, 2002 Charité SB III 20 46 (6–156) VQ 7° avg. ROM N/A 95% reduction in pain None related to implant
of interest stated; OR, operation; ROM, range of motion; VQ, validated questionnaire (e.q., SF36,
Clinical results of patients with shorter follow-up not reported.bNot clearly stated for radiographic details but implied since 7 patients reported for Oswestry.
Reproduced from Wai E, Selmon G, Fraser RD. Disc replacement arthroplasties: can the success of hip
a
Oswestry) used in clinical assessment.
and knee replacements be repeated in the spine? Semin Spine Surg 2003;(15)4:473–482.
CHAPTER 40/LUMBAR DISC REPLACEMENT / 397
adjacent-level degeneration after fusion have used MRI or have longer follow-up times (28–31).
The work of K umar et al. is the most similar in method­ology to the study by Bertagnoli et al. but with a much longer follow-up period (32). They found an 8% incidence of radiographically determined adjacent-level disease in patients 5 years following lumbar fusion with a normal sagittal alignment. Furthermore, in an MRI study we car­ried out 10 years after anterior lumbar interbody fusion (28), the adjacent disc was found to be free of degeneration in 68% of cases. We examined the patter n of degeneration in the remainder of the lumbar spine, including the pres­ence of skip lesions, comparing this with the reports of MRI findings in normal asymptomatic populations. Based on this comparison, we concluded that adjacent-level de­generation was determined more by constitutional factors than by the presence of a solid fusion.
Further challenging the ability of disc replacement to preserve the adjacent levels, a study by Zeegers found that 24% of patients required adjacent-level surgery within 2 years of having an SB Charité III prosthesis inserted (33). While this high incidence may represent a failure to adequately rule out adjacent-level pathology before performing the index procedure, it is much higher than any reported for lumbar fusion. In any ev ent, there is clearly no evidence to date that disc replacement protects against adjacent level degeneration.
FOOD AND DRUG ADMINISTRATION STATUS
At the present time, the U.S. Food and Drug Adminis­tration (FDA) has not approved disc replacement devices for routine marketing, and currently the use of these devices is for investigational purposes only. To obtain approval for general use the manufacturer is required to demonstrate to the FDA’s satisfaction that their prosthesis is as substantially equivalent (as safe and effective) to an already approved device. Specif ic guidelines concerning the indications, in vivo biomechanical testing, and clini­cal results of devices have been published for spinal implants (34).
Two separate multicenter, randomized controlled clini­cal trials are in progress in the United States under the FDA’s Investigational Device Exemption. The SB Charité III is being compared with anterior interbody fusion using the Bagby and Kuslich (BAK) device, while the ProDisc is being tested against combined anterior and posterior fusion using pedicle screws and an interbody fusion construct (35). Both trials intend to recruit between 300 and 500 patients and the manufacturers hope to achieve FDA approval within the next few years. The initiation of a FDA-approved trial in the United States is pending. The PDN has been given approval by the Canadian Therapeutic Directorate to begin a clinical trial and three Canadian centers are recruiting patients for a prospective evaluation of the PDN (4).
It is expected that these trials will address short-term safety issues related to the prostheses and whether the clinical efficacy is similar to fusion at 2 years. As men­tioned previously, these studies are unlikely to have suffi­cient pow er to detect a dif ference with fusion unless there is a large clinical effect. It is therefore essential that long­term follow-up of the studies be carried out to determine efficacy, the overall safety of the implants, and their abil­ity to protect adjacent levels.
THE FUTURE OF DISC REPLACEMENT
It is the spectacular success of arthroplasty of the hip and knee that has continued to drive the development of artificial disc technology. Further enthusiasm has been generated by the demonstration that a number of prosthe­ses have restored range of motion to the disc and by the clinical use of the Link SB Charité device for over 10 years. However, this measure of technical success and implant longevity does not necessarily mean that the future of disc replacement is certain. It is only if it can be shown in the long term to perform at least as well as fusion, without compromise from implant failure, hetero­topic bone formation or excessive facet degeneration leading to stenosis, that the place of disc replacement will be finally assured.
From the reported results of case series described herein, it seems likely that current FDA trials will demon­strate short-term eff icacy and safety, leading to approval of these devices for routine marketing. Because of antic­ipated demand, the expected FDA approval is likely to be followed by extensive and widespread clinical usage of these devices. Based on the experience associated with the release of other spinal implants as well as the knowl­edge gained from hip and knee arthroplasty, it will be only a matter of time before surgeons are confronted with problems created by implant failure. There is, however, one major advantage for the spinal surgeon compared with the hip or knee surgeon undertaking revision proce­dures for a failed prosthesis. Unlike surgery for the hip and knee, there is unlikely to be a great functional disad­vantage in converting spinal ar throplasty to arthrodesis; moreover, it may be possible to circumvent the surgical site by retrieving the situation with a posterolateral fusion. However, when it is necessary to remove a large lumbar interbody device anteriorly, the proximity of the major vessels and other vital organs, the scarring from the original surgery, and the pathology associated with implant failure all combine to make the revision proce­dure extremely difficult and potentially disastrous (12).
Clearly the introduction of these devices into the com­munity should be with caution. The current “gold stan­dard” investigations for diagnosis of discogenic back pain, MRI, and discography have signif icant high false­positive rates.A large potential for misdiagnosis resulting in surgery for pain not arising from the disc exists; hence
398 /SECTION V/SPECIFIC CLINICAL ENTITIES
the unsatisfactory outcomes often reported for treatment of discogenic back pain.
Combined anterior and posterior fusion has been pro­moted by many spinal surgeons for the management of back pain since it deals with many different potential pain sources, including not only the disc but also the ligaments and facet joints. In contrast, disc arthroplasty targets only the disc. It is, therefore, more vulnerable to the effects of misdiagnosis leading to the replacement of a nonpainful disc rather than dealing with the actual pain source. This is countered by the restoration of the functional spinal unit’s range of motion. However, it is unclear whether the extra few degrees of range of motion offered by a disc replace­ment over fusion is functionally significant, especially given the motion a v ailab le at adjacent le v els and hip joints.
Future models of spinal arthroplasty will no doubt aim to replicate the elastic properties of the disc without incurring the problem of wear particles, and also will attempt to address facet joint pathology. It will take a great deal of time and carefully controlled long-term tri­als to determine whether or not these devices offer the best alternative for patients undergoing surgery for disco­genic low back pain.
REFERENCES
1. Szpalski M, Gunzburg R, Mayer M. Spine arthroplasty: a historical review. Eur Spine J 2002;11:S65–S84.
2. Fernstrom U. Arthroplasty with intercorporal endoprosthesis in herni­ated disc and in painful disc. Acta Orthop Scand 1966;10:S287–S289.
3. Ray CD. The PDN prosthetic disc-nucleus device. Eur Spine J 2002; 11:S137–S142.
4. Klara PM, Ray CD. Artificial nucleus replacement—clinical experi­ence. Spine 2002;27:1374–1377.
5. Bertagnoli R, Schonmayr R. Surgical and clinical results with the PDN prosthetic disc-nucleus device. Eur Spine J 2002;11:S143–S148.
6. Matthews H, Le Huec JC, Bertagnoli R, et al. Design, rationale and early multicenter evaluation of Maverick total disk arthroplasty. Paper presented at: International Meeting on Advanced Spine Technologies; May 2002; Montreux, France.
7. Lemaire JP, Skalli W, Lavaste F, et al. Inter vertebral disc prosthesis. Results and prospects for the year 2000.Clin Or thop 1997;337:64–76.
8. Link HD. History, design and biomechanics of the Link SB Charite artificial disc. Eur Spine J 2002;11:S98–S105.
9. Marnay T. L’arthroplastie intervertebrale lombaire. Med Orthop 1991; 25:48–55.
10. Bertagnoli R, Kumar S. Indications for full prosthetic disc arthro­plasty: a correlation of clinical outcome against a variety of indica­tions. Eur Spine J 2002;11:S131–S136.
11. Enker P, Steffee A, McMillin C, et al. Artificial disc replacement. Pre­liminary report with a 3-year minimum follow-up. Spine 1993;18: 1061–1070.
12. Fraser RD, Ross ER, Lowery G. AcroFlex: design and results. Spine J 2004 (in press).
13.Waddell G, McCulloch JA, Kummel E, et al. Nonorganic physical signs in low-back pain. Spine 1980;5:117–125.
14. Wai E, Selmon G, Fraser RD. Disc replacement arthroplasties: can the success of hip and knee replacements be repeated in the spine? Semin Spine Surg 2003:15(4):473–482.
15. Fritzell P, Hagg O, Wessberg P, et al. 2001 Volvo award winner in clin­ical studies: lumbar fusion versus nonsurgical treatment for chronic low back pain. A multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine 2001;26:2521–2534.
16. Bjarke-Christensen F, Stender-Hansen E, Laursen M, et al. Long-term functional outcome of pedicle screw instrumentation as a support for posterolateral spinal fusion: randomized clinical study with a 5-year follow-up. Spine 2002;27:1269–1277.
17. Kuslich SD, Ulstrom CL, Griffith SL, et al. The Bagby and Kuslich method of lumbar interbody fusion. History, techniques, and 2-year follow-up results of a United States prospective, multicenter trial. Spine 1998;23:1267–1278.
18. Kuroki H, Tajima N, Kubo S. Clinical results of posterolateral fusion for degenerative lumbar spinal diseases: a follo w-up study of more than 10 years. J Orthop Sci 2002;7:317–324.
19. Liljenqvist U, O’Brien JP, Renton P. Simultaneous combined anterior and posterior lumbar fusion with femoral cortical allograft. Eur Spine J 1998;7:125–131.
20. O’Beirne J, O’Neill D, Gallagher J, et al. Spinal fusion for back pain: a clinical and radiological review. J Spinal Disord 1992;5:32–38.
21. Kleeman TJ, Ahn UM, Talbot-Kleeman A. Laparoscopic anterior lum­bar interbody fusion with rhBMP-2: a prospective study of clinical and radiographic outcomes. Spine 2001;26:2751–2756.
22. Cherkin DC, Deyo RA, Battie M, et al. A comparison of physical ther­apy, chiropractic manipulation, and provision of an educational book­let for the treatment of patients with low back pain. N Engl J Med 1998;339:1021–1029.
23. Nelemans PJ , Bie RA, deVet HCW , et al. Injection therap y for subacute and chronic benign low back pain. Cochrane Database of Systematic Reviews. 2002;4.
24. Saal JA, Saal JS. Intradiscal electrothermal treatment for chronic discogenic low back pain: prospective outcome study with a minimum 2-year follow-up. Spine 2002;27:966–973.
25. Tulder MW, Cherkin DC, Berman B, et al. Acupuncture for low back pain. Cochrane Database of Systematic Reviews. 2002;4.
26. Tulder MW, Malmivaara A, Esmail R, et al. Exercise therapy for low back pain. Cochrane Database of Systematic Reviews. 2002;4.
27. Cinotti G, David T, Postacchini F . Results of disc prosthesis after a min­imum follow-up period of 2 years. Spine 1996;21:995–1000.
28. Penta M, Sandhu A, Fraser RD. Magnetic resonance imaging assess­ment of disc degeneration 10 years after anterior lumbar interbody fusion. Spine 1995;20:743–747.
29. Hanley EN, Shapiro DE. The development of low-back pain after exci­sion of a lumbar disc. J Bone Joint Surg 1989;71-A:719–721.
30. Kumar MN, Jacquot F, Hall H. Long-term follow-up of functional out­comes and radiographic changes at adjacent levels following lumbar spine fusion for degenerative disc disease. Eur Spine J 2001;10: 309–313.
31. Nakai S, Yoshizawa H, Kobayashi S. Long-term follow-up study of posterior lumbar interbody fusion. J Spinal Disord 1999;12:293–299.
32. Kumar MN , Baklanov A, Chopin D. Correlation between sagittal plane changes and adjacent segment degeneration following lumbar spine fusion. Eur Spine J 2001;10:314–319.
33. Zeegers WS, Bohnen LM, Laaper M, et al. Artif icial disc replacement with the modular type SB Charité III: 2-year results in 50 prospectivel y studied patients. Eur Spine J 1999;8:210–217.
34. Food and Drug Administration. FDA Guidance for Spinal System 510(k)s: U.S. Department of Health and Human Services, 2000.
35. Hochshuler SH, Ohnmeiss DD, Guyer, et al. Artificial disc: prelimi­nary results of a prospective study in the United States. Eur Spine J 2002:11:S106–S110.
CHAPTER 41

Disc Herniation: Definition and Types

Tom Bendix
Disc herniation used to be considered as a local bulge on a disc surface, causing pressure on a nerve root. This was based largely on the fact that m y elo gram was the onl y w a y to establish the diagnosis. As myelogram is a highly inva­sive procedure, which also exposes the patient to signif i­cant radiation levels, it is considered ethically unaccept­able in the examination of asymptomatic individuals. Today, computed tomography (CT) and magnetic reso­nance imaging (MRI) studies in asymptomatic individuals have shown that the presence of a local bulge on the disc surface certainly does not correlate convincingly with the classic symptoms of disc herniation (Fig. 41-1) (1–6).
Such studies have sparked a totally new era for this diagnosis. It is likely that disc herniation symptoms are predominantly initiated by nuclear tissue coming into physical contact with the nerve root, whereas a (local) bulge does not normally cause nerve damage (Fig. 41-1). Moreover, after a passed clinical cause the bulge consists of scar tissue, forming the morphologic “herniation” (7).
Several terms have been used to describe this condi­tion: disc herniation, herniated nucleus pulposus (HNP), prolapse, and slipped disc are those most often used. Time has come, however, to redef ine the condition as a syndrome characterized by nerve damage, primarily caused by irritation from nuclear tissue, giving rise to a production of a variety of cytokines and other inflamma­tory or autoimmune components (8–21), leading to sec­ondary pressure hypersensitivity (22,23).
While lifetime prevalence of sciatica of any etiology is about 40% (24), no authors have been able to give a seri­ous frequency of lifetime prevalence of lumbar disc her­niation (LDH). This may be in agreement with the vague definitions described later in the chapter that the most frequent rough estimate is about 3% to 4%. The 1-year incidence has been estimated at 0.1% to 0.5% (25). Of patients with acute low back pain, only 1% have nerve­root symptoms (26). Age distribution has its peak close to 40, and male: female ratio is probably close to 1:1 for all
LDH, whereas for those operated upon it is 1.5:1 to 2:1 (5,27,28).
In this chapter only lumbar annular (not end plate) disc
herniation is addressed.
The onset of annular rupture is usually the end point of gradual disc degeneration, which in turn seems more related to genetic issues than to physical loads (29). Of physical factors, flexion plays the greatest role, but even this factor is not impressive (30).
DEFINITIONS
Considering the aforementioned poor correlation between clinical and imaging findings, different aspects of definitions have to be considered.
Patho-Anatomic Types
In accordance with today’s knowledge (as discussed later in the chapter), the aspect of the nucleus being con­tained or not seems most relevant as the primary nerve damage is most likely associated with the inflammatory influence of free nucleus pulposus tissue on the nerve root. If nerve damage resulted primarily from pressure, it is not likely that so many silent disc herniations are seen in MRI studies. Pressure is, how e ver , ob viousl y important secondarily, as pressure on any inflamed structure causes pain. But as the primary lesion, pressure alone only rarely seems to be relevant (Fig. 41-2).
Contained
The disc bulges locally, but the outermost layer is still intact. In most cases it is questionable whether this con­dition causes root damage, rather than referred disco­genic pain. If the bulge compresses the dorsal ganglion of the intervertebral nerve root, however, it is likely that the presence of nuclear material directly touching the root
399
400 /SECTION V/SPECIFIC CLINICAL ENTITIES
FIG. 41-1. The three disc herniations shown here are identical on computed tomography or magnetic reso­nance imaging. Clinically only the one with chemical irr i­tation of the nerve root (bottom, left) produces symp­toms. Bottom right: A healed, but now clinically silent herniation.
may not be necessary (31,32). This is substantiated by research demonstrating that the threshold for compres­sion-induced neuronal firing is about half that for other parts of the nerve root (33). Likewise, if a chemically inactive bulge causes compression over such a wide area of the nerve root that the root suffers ischemia (33), this may also sensitize the nerve root without any chemically induced lesion (34–36) (Fig. 41-3).
It seems as if contained disc herniations or more dif-
fuse disc herniation displacements (5,37,38) represent a
poorer prognosis as opposed to a more well-defined her­niation, probably because the first condition is only a small part of a more substantial degeneration (Fig. 41-6). Some authors also divide “contained disc herniations” into “soft” and “hard” categories. Thus, pain from a pri­mary contained disc herniation is most likely rather a “simple” discogenic pain, which causes back pain that dominates over optional leg pain. Such leg pain can be “radicular”/dermatomal in its perceived location (39), but will most often be diffuse in its distribution.
FIG. 41-2. The different types of disc herniations.
CHAPTER 41/DISC HERNIATION: DEFINITION AND TYPES / 401
FIG. 41-3. The main basic pathology in disc herniation is inflammation. Pressure on the ganglion and ischemia (wide­spread compression) may also cause a primary lesion, but plays a greater role as secondary irritation when existing inflammation has caused nerve damage.
Complete = Protruded = Free
The nuclear material has broken through the outermost layer of annulus fibrosus, and can be seen in the canal, and is therefore no longer contained. It is extruded from the fissure of the disc, whether or not it is in continuum with the central nuclear tissue. It is not quite clear from literature if a herniation that has passed the outermost annulus layer, but still remains subligamentous (40), is considered “free”. Those protruding through the ligament are called “transligamentous” (40).
Sequestered
A free nucleus fragment, no longer in contact with the annular canal it originated from, is clinically meaningful in the interpretation of fluctuating symptoms, and during surgery.
“No-Bulge Herniation”
FIG. 41-4. The location in the segment can be intraspinal (a), foraminal (b), or extraforaminal (c).
The intraspinal herniation is most often paramedian as shown on Fig. 41-4, but can be median as well. “Extraforaminal” herniation is also known as “extreme lateral”, and seems to cause a higher degree of pain than the other types (41).
Clinical T ypes
The classic disc herniation starts after a period with only back pain, or back pain that dominates over leg pain/sciatica. When leg pain takes over and dominates, the course of a disc herniation begins (Fig. 41-5).
It may be argued that the clinical disc herniation begins with the initial back pain. However, when a period of (dominating) back pain of discogenic origin starts, it is only seldom that it is follo w ed by a disc herniation. More­over, dominating leg pain may follow shortly after the onset of back pain, or after months or years with back pain. Probably the short course corresponds to a single, and “clean” annular rupture, whereas a long-lasting “pro­drome” may correspond to a herniation in a disc that is highly degenerated (Fig. 41-6).
It seems likely that some nucleus-tissue–induced nerve damage is caused by leakage of nuclear chemicals that do not physically form a bulge on the disc (Olmarker, per­sonal communication). As with other nerve-root lesions, a mechanical component is needed to cause the leakage.
Radiologic T ypes
Radiologically, LDH is defined as a localized bulge on a disc. Several researchers have tried to make a strict distinc­tion between prolapse and disc protrusion by means of deciding how much of the entire intervertebral-disc cir­cumference is taken up by the bulging “dome”. The reason why no consensus has ever been made is most likely that it has become clearer that the correlation between a certain “dome” and the clinical symptoms is small (1).
Another radiologic categorization refers to the location of the LDH on the circumference (Fig. 41-4).
FIG. 41-5. A typical course of a disc herniation. See text.
402 /SECTION V/SPECIFIC CLINICAL ENTITIES
FIG. 41-6. The clinical course of a disc herniation in relation to the different stages of what happens in the disc. See text.
The distribution of leg pain usually follows the root leaving the spinal canal one level caudal to the herniation (Fig. 41-7). If the herniation is more centrally located, the root leaving two levels below will occasionally be affected. A central herniation may even damage the roots that exit several le v els belo w, as seen in the “cauda equina syndrome” (see below). Or it may simply cause—or take part in—spinal stenosis, most often when the canal is already narrow at that level (see Chapters 1 and 48).
If the herniation is foraminal or extraforaminal, the
nerve root taking off at the same level may be affected.
About 95% of lumbar herniations are located in the two lo w er discs, 5% at L3-4, and onl y v ery few abo v e that level.
The symptoms of “cauda equina syndrome”, where several sacral roots are involved, include flatus inconti­nence, urinary incontinence, and groin hypoanesthesia. The influence on the vesica urticaria sphincter is most often retention. Urinary incontinence may either be seen because of retention in terms of overflow, or as a primary neurologic disturbance. Groin hypoanesthesia can be uni­lateral or bilateral.
NATURAL HISTORY
The natural course of LDH has certainly not been accurately stated (42). It varies with:
• different intensity of clinical symptoms including the
degree of paresis
• coexisting pathology, particularly whether the actual
disc is highly degenerated or not, but also recess or spinal stenosis, spondylolisthesis, and so forth (43)
• psychosocial factors (e.g., employment and higher
social group correlates to a faster recovery) (44).
FIG. 41-7. The typical root irritations with paramedian lum­bar disc herniation at various levels.
The course does not seem influenced by sex or age (44), the latter at least not with complete herniation (5).
It is problematic that the clinical courses described in various studies represent a variety of definitions of LDH, most likely including many without actual nuclear herni­ation. The literature makes no conclusions on an average course of the different phases.