Lumbar Total Disc Arthroplasty


Summary of Key Points

  • Lumbar total disc replacement (TDR) has been studied extensively since its initial use in the 1980s in Europe. Results of long-term follow-up studies in Europe as well as multiple prospective, randomized trials in the United States have found TDR to produce good outcomes that are noninferior or superior to fusion.

  • TDR function depends on biomechanical factors such as articulation, degrees of freedom, constraint, rotation, and translation. These devices can be classified in terms of such characteristics.

  • There are currently two TDR devices approved by the U.S. Food and Drug Administration that are available for single-level lumbar arthroplasty: activL and ProDisc-L.

  • One of the potential benefits of TDR is maintaining motion and thereby minimizing stress on adjacent segments. The literature supports lumbar TDR as having a protective effect in reducing the occurrence of adjacent segment degeneration (ASD) compared with fusion. One study found that with each degree of motion gained at the TDR level, there was a decrease in the percentage of patients with ASD. When compared with fusion, the TDR patients had significantly lower odds of developing radiographic ASD.

  • Clinical outcomes and risks of complications related to lumbar TDR can be optimized by rigorously employing appropriate patient selection criteria. Of particular note, bone quality and the condition of the facet joints must be evaluated.

  • Several studies, employing a variety of methodologies, have investigated the costs associated with TDR surgery. Results have demonstrated that TDR is cost-neutral or less expensive than fusion.

  • Although insurance coverage for single-level lumbar TDR has expanded in recent years, obstacles to reimbursement remain. Insurance companies often will not cover hybrid reconstruction and multi-level arthroplasty, despite high-quality evidence documenting their safety and efficacy.

Low back pain has an annual prevalence of 38% and represents a significant socioeconomic burden, with costs exceeding $100 billion per year in the United States alone. , Lumbar degenerative disc disease (DDD) is a common cause of low back pain. In most cases, DDD can be successfully treated nonoperatively with physical therapy, medications, and lifestyle modifications. Surgical treatment for refractory cases traditionally involved fusion of the affected spinal segment to eliminate motion and the associated pain. An alternative to fusion is replacement of the painful disc with an artificial device. Currently, two lumbar total disc replacement (TDR) devices have been approved by the U.S. Food and Drug Administration (FDA) and remain available for use: ProDisc-L (Centinel Spine, West Chester, PA) and activL (Aesculap AG, Tuttlingen, Germany). The Charité Disc by (DePuy Synthes, Raynham, MA) was the first lumbar disc approved but was eventually discontinued by DePuy. Multiple other designs are in trial and development stages or being used outside of the United States. Extensive research has been published on outcomes of lumbar disc replacement, with studies reporting 5- to 10-year follow-up periods in the United States and studies of more than 10 years available in Europe.

Background

The intervertebral disc is a complex structure that plays a key role in range of motion and load transfer in the lumbar spine. The nucleus pulposus absorbs compressive loads, whereas the annulus fibrosus resists shear forces and contains the nucleus. A normal disc in the lumbar spine bears 80% of compressive loads. It is subjected to one to 2.5 times body weight on ambulation and up to 10 times body weight when lifting a heavy load. The lumbar disc also allows for rotation and translation in three orthogonal planes. Characteristics of motion vary according to the level, with more rotation occurring in the upper lumbar spine and more flexion and extension in the lower lumbar spine. The center of rotation in the sagittal plane is usually located dorsal and caudal to the center of the rostral end plate but varies slightly with flexion and extension.

With disc degeneration, the nucleus pulposus loses water content and becomes less compliant, leading to collagen degeneration and fissures in the annulus. Inflammatory cytokines are released from the nucleus, and sensory nerve fibers proliferate deeper into the disc space, resulting in discogenic pain. The disc’s biomechanical characteristics also become altered. As the disc becomes more rigid and loses height, more stress is transferred to the facet joints. This process results in eventual disc space collapse, foraminal narrowing, facet degeneration, soft tissue hypertrophy, and compression of neural elements.

The traditional gold standard operative treatment for symptomatic DDD in patients who fail conservative therapy with persistent functionally incapacitating pain is arthrodesis of the affected segment and decompression of stenosis, if needed. In theory, fusion targets the pain associated with lumbar disc degeneration by removing the disc material and eliminating motion at the affected segements. This may be accomplished using a variety of approaches and fixation options. Arthrodesis has been performed since 1911, with fusion rates exceeding 90% in some reports of patients with DDD. However, fusion surgery in the setting of lumbar DDD remains controversial because of concerns regarding clinical benefit, pseudoarthrosis and ASD. Evidence of ASD is observed after 30% to 40% of fusions, , likely caused by altered spinal biomechanics. One potential advantage of arthroplasty is that it allows each patient to find his or her own balance and maintain motion. The rationale for lumbar TDR is to remove the painful disc while maintaining or restoring motion, thereby reducing the risk of adjacent segment degeneration.

A successful TDR design must take into account multiple factors, including the multidirectional angular and translational range of motion, the variable center of rotation, and the need for fixation without significant subsidence. Currently available TDRs in the United States do not attempt to replace the normal viscoelastic disc structure but instead replace it with a sliding rotational joint without inherent elasticity. The implant materials must be durable without accruing significant wear. However, newer designs not yet available in the United States incorporate a viscoelastic component. These single-piece implants contain deformable elastomeric cores that mimic the shock absorption of a normal nucleus pulposus.

Indications

As with many other spine operations, proper patient selection is one of the most important factors for successful TDR. The most common indications are listed in Box 125.1 . The majority of patients who qualify for TDR are younger than 60 years of age. This excludes most patients with degenerative processes in dorsal spinal structures (e.g., facet degeneration, ligamentum flavum hypertrophy) and those with inadequate bone stock as quantified by evaluating bone mineral density (BMD). Bertagnoli and colleagues found that in carefully selected patients older than 60 years of age, TDR resulted in significant clinical improvement and high patient satisfaction rates. Even in this group of 22 patients, however, there were two cases of radiculopathy attributed to circumferential stenosis and two cases of implant subsidence. DDD must be the main, if not the only, source of back pain. Because most cases of low back pain from DDD resolve with nonoperative treatment, surgical candidates must have failed those options for at least six months. TDR candidates should also have a history and physical findings indicative of activity-related back pain that worsens with loading and flexion. Significant pain and disability should be present to justify the potential risks and recovery period associated with operative intervention. Also, they must have failed exercise-based therapy, medication therapy, injections, and activity modification. Because current TDR implants are typically implanted via an anterior retroperitoneal surgical approach, potential contraindications include prior retroperitoneal surgery, retroperitoneal radiation, and morbid obesity with a markedly protuberant abdomen.

Box 125.1
Common Indications and Contraindications for Lumbar Total Disc Arthroplasty

Indications

  • Age 18‒60 years

  • Symptomatic, function-limiting degenerative disc disease L3‒L4 to L5‒S1 with or without confirmatory discography

  • Failure of nonoperative therapy for at least 6 months

  • Bone density: dual energy x-ray absorptiometry T-score > ‒1.0

  • Previous posterior decompression if facet joints are not compromised

  • No previous retroperitoneal approach

  • No significant arterial calcification

  • Recurrent disc herniation contiguous with disc space with significant low back pain in a patient with no other contraindication who would be considered to be a fusion candidate

Absolute Contraindications

  • Poor bone quality (e.g., osteoporosis, osteopenia, metabolic bone disease, tumor)

  • Severe facet degeneration

  • Spondylolisthesis and spondylolysis

  • Circumferential stenosis

  • Scoliotic deformity >5 degrees

  • Current or past trauma to involved vertebrae

  • Morbid obesity

  • Infection

  • Autoimmune disorder

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