Tag: Arthroplasty

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Health Care Costs Following Anterior Cervical Discectomy and Fusion or Cervical Disc Arthroplasty

Spine 2024;49:530–535

Study Design. Observational cohort study.

Objective. To describe the postoperative costs associated with both anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) in the two-year period following surgery.

Summary of Background Data. CDA has become an increasingly common alternative to ACDF for the treatment of cervical disc disorders. Although a number of studies have compared clinical outcomes between both procedures, much less is known about the postoperative economic burden of each procedure.

Materials and Methods. By analyzing a commercial insurance claims database (Marketscan, Merative), patients who underwent one-level or two-level ACDF and CDA procedures between January 1, 2017 and December 31, 2017 were identified and included in the study. The primary outcome was the cost of payments for postoperative management in the two-year period following ACDF or CDA. Identified postoperative interventions included in the study were: (i) physical therapy, (ii) pain medication, (iii) injections, (iv) psychological treatment, and (iv) subsequent spine surgeries.

Results. Totally, 2304 patients (age: 49.0 ± 9.4 yr; male, 50.1%) were included in the study. In all, 1723 (74.8%) patients underwent ACDF, while 581 (25.2%) underwent CDA. The cost of surgery was similar between both groups (ACDF: $26,819 ± 23,449; CDA: $25,954 ± 20,620; P = 0.429). Thirty-day, 90-day, and two-year global costs were all lower for patients who underwent CDA compared with ACDF ($31,024 vs. $34,411, $33,064 vs. $37,517, and $55,723 vs. $68,113, respectively).

Conclusion. Lower two-year health care costs were found for patients undergoing CDA compared with ACDF. Further work is necessary to determine the drivers of these findings and the associated longer-term outcomes.

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Symptomatic Adjacent Level Disease Requiring Surgery: Analysis of 10-Year Results From a Prospective, Randomized, Clinical Trial Comparing Cervical Disc Arthroplasty to Anterior Cervical Fusion

Neurosurgery 84:347–354, 2019

Ten-year follow-up data from the US Food and Drug Administration investigational device exemption trial comparing BRYAN  Cervical Disc (Medtronic, Dublin, Ireland) arthroplasty to anterior cervical discectomy and fusion (ACDF) demonstrated that disc arthroplasty maintained range of motion and improvements in overall success and neck disability.

OBJECTIVE: To compare the 10-yr rates of symptomatic adjacent level disease requiring surgery (SALDRS).

METHODS: Prospective randomized trial data were analyzed comparing BRYANR  Cervical Disc arthroplasty to ACDF for single-level cervical disc disease with concordant radiculopathy or myelopathy with clinicoradiographic analysis at 10 yr. Secondarily, 84-mo data were pooled with PRESTIGE   Cervical Disc arthroplasty (Medtronic) study data to provide overall rates of SALDRS.

RESULTS: Significantly greater overall success was maintained at every postoperative interval with an overall success rate of 81.3% with BRYAN  disc and 66.3% with ACDF (P = .005) without loss of motion preservation (8.69◦ vs 0.60◦). Reoperation at adjacent levels up to the 120-mo visit was 9.7% in the arthroplasty group and 15.8% in the ACDF group (P = .146). The combined data from BRYAN and Prestige ST demonstrate that BRYAN  and Prestige disc groups had a lower rate of second surgeries at the adjacent levels, up to the 84-mo visit, compared to the combined ACDF groups (6.9% vs 11.7%; P = .023).

CONCLUSION: Compared with ACDF, fewer patients with the BRYAN  disc required surgery for symptomatic adjacent level degeneration, but this did not achieve statistical significance. Analysis of combined study data using Bryan and Prestige discs shows significant differences in SADLRS as early as 7 yr.

 

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Cervical Disc Arthroplasty: Current Evidence and Real-World Application

Neurosurgery 83:1087–1106, 2018

Cervical total disc replacement (cTDR) is still considered a developing technology, with widespread clinical use beginning in the early 2000s. Despite being relatively new to the marketplace, the literature surrounding cTDR is abundant.

We conducted a thorough review of literature published in the United States (US) and outside the US to report the current global state of cTDR research and clinical use. Search criteria were restricted to publications with a clinical patient population, excluding finite element analyses, biomechanical studies, cadaver studies, surgical technique-specific papers, and case studies. US publications mostly encompass the results of the highly controlled Food and Drug Administration Investigational Device Exemption trials.

The predominantly level I evidence in the US literature supports the use of cTDR at 1 and 2 surgical levels when compared to anterior cervical discectomy and fusion. In general, the outside the US studies typically have smaller patient populations, are rarely controlled, and include broader surgical indications. Though these studies are of lower levels of evidence, they serve to advance patient indications in the use of cTDR.

Complications such as secondary surgery, heterotopic ossification, and adjacent segment degeneration also remain a focus of studies. Other external challenges facing cTDR technology include regulatory restrictions and health economics, both of which are beginning to be addressed.

Combined, the evidence for cTDR is robust supporting a variety of clinical indications.

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NuNec™ Cervical Disc Arthroplasty Improves Quality of Life in Cervical Radiculopathy and Myelopathy: A 2-Year Follow-up

Neurosurgery 83:422–428, 2018

Anterior cervical disc replacement is an alternative to fusion for the treatment of selected cases of radiculopathy andmyelopathy. We report clinical and radiological outcomes after disc replacement with the NuNec™ artificial cervical disc (Pioneer (R)  Surgical Technology, Marquette, Michigan) with subgroup analysis.

OBJECTIVE: To review clinical and radiological outcomes after anterior cervical disc replacement with the NuNec™ artificial cervical disc.

METHODS: A consecutive case series of patients undergoing cervical disc replacement with the NuNec™ artificial disc was conducted. Clinical outcomes were assessed by questionnaires preoperatively and up to 2 yr postoperatively including neck and arm pain, Neck Disability Index, Euroqol 5-dimensions, and Short Form-36; x-rays from the same period were analyzed for range of movement and presence of heterotopic ossification.

RESULTS: A total of 44 NuNec™ discs were implanted in 33 patients. Clinical improvements were seen in all outcomes; significant improvements on the Neck Disability Index, Euroqol 5-dimensions, and physical domain of the Short Form-36 were maintained at 2 yr. There was a mean of 4◦ range of movement at the replacement disc level at 2 yr, a significant reduction from baseline; there was also progression in levels of heterotopic ossification. Complications included temporary dysphagia (10%) and progression of disease requiring foraminotomy (6%); no surgery for adjacent level disease was required. There was no significant difference in the outcomes of the radiculopathy and myelopathy groups.

CONCLUSION: Clinical outcomes using the NuNec™ disc replacement are comparable with other disc replacements. Although the range of movement is reduced, the reoperation rate is very low.

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Long-term Outcomes of the US FDA IDE Prospective, Randomized Controlled Clinical Trial Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion”

PCM vs ACDF

Spine 2015;40:674–683

Study Design. Prospective, multicenter, randomized clinical trial.

Objective. To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single- level degenerative spondylosis between C3–C4 and C7–T1 with or without prior cervical fusion.

Summary of Background Data. The 2-year results of the PCM Cervical Disc trial have been reported previously. The current study reports the long-term results of the same trial.

Methods. Patients with single-level cervical spondylosis and radiculopathy with or without myelopathy unresponsive to nonoperative treatment were enrolled. The per protocol patient sample at 5 years included 293 patients (163 PCM, 130 ACDF). Adverse events and secondary surgical procedures are reported on the cohorts through current follow-up, which include 110 patients (68 PCM, 42 ACDF) at 7 years.

Results. At 5 years postoperative, all patient-reported outcomes— neck and arm pain visual analogue scale score, neck disability index, and general health (36-Item Short Form Health Survey physical and mental component scores: physical component summary, mental component summary)—were significantly improved from baselines in both groups, and mean scores were significantly better in the PCM group for neck disability index (P = 0.001), neck pain (P = 0.002), general health (Pphysical component summary= 0.014; P mental component summary= 0.004), and patient satisfaction (P = 0.005).
PCM patients trended toward fewer 2- to 7-year device-related
serious adverse events (1/214, 0.5% PCM; 2/190, 1.1% ACDF) and secondary surgical procedures (7/211, 3.3% PCM; 14/290, 7.6% ACDF). Adjacent-level degeneration was radiographically more frequent after ACDF (33.1% PCM, 50.9% ACDF; P = 0.006) and was the primary indication for the increase in late-term secondary surgical procedures after ACDF.

Conclusion. The long-term results show good clinical outcomes after ACDF and PCM arthroplasty. PCM patients showed greater improvement in neck disability index and neck pain scores with a lower rate of radiographical adjacent-level degeneration and a trend toward fewer secondary surgical procedures. These data support PCM arthroplasty to be a viable and sustainable alternative to ACDF.
Level of Evidence: 1

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Arthroplasty Versus Fusion in Single-Level Cervical Degenerative Disc Disease

Fusion

Spine 2013;38:E1096–E1107

Study Design. A systematic review of randomized controlled trials (RCTs).

Objective. To assess the effects of arthroplasty versus fusion in the treatment of radiculopathy or myelopathy, or both, due to singlelevel cervical degenerative disc disease.

Summary of Background Data. There is ongoing debate about whether fusion or arthroplasty is superior in the treatment of single-level cervical degenerative disc disease. Mainly because the intended advantage of arthroplasty compared with fusion, prevention of symptoms due to adjacent segment degeneration in the long term, is not confirmed yet. Until sufficient long-term results become available, it is important to know whether results of 1 of the 2 treatments are superior to the other in the first 1 to 2 years.

Methods. We searched electronic databases for randomized controlled trials. We included randomized controlled trials that directly compared any type of cervical fusion with any type of cervical arthroplasty, with at least 1 year of follow-up. Study selection was performed independently by 3 review authors, and “risk of bias” assessment and data extraction were independently performed by 2 review authors. In case of missing data, we contacted the study authors or the study sponsor. We assessed the quality of evidence.

Results. Nine studies (2400 participants) were included in this review; 5 of these studies had a low risk of bias. Results for the arthroplasty group were better than the fusion group for all primary comparisons, often statistically significant. For none of the primary outcomes was a clinically relevant difference in effect size shown. Quality of the evidence was low to moderate.

Conclusion. There is low to moderate quality evidence that results are consistently in favor of arthroplasty, often statistically significant. However, differences in effect size were invariably small and not clinically relevant for all primary outcomes.

Level of Evidence: 1

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Total Disc Replacement for Chronic Discogenic Low Back Pain: A Cochrane Review

TDR

 Spine 2013 ; 38 : 24 – 36

Study Design. Systematic literature review.

Objective. To assess the effect of total disc replacement for chronic low back pain due to lumbar degenerative disc disease compared with fusion or other treatment options.

Summary of Background Data. There is an increasing use in disc replacement devices for degenerative disc disease, but their effectiveness compared with other interventions such as fusion of the motion segment or conservative treatment remains unclear.

Methods. A comprehensive search in PubMedCentral, MEDLINE, EMBASE, BIOSIS, ClinicalTrials.gov, and FDA trials register was conducted. Randomized controlled trials comparing total disc replacement with any other intervention for degenerative disc disease were included. Risk of bias was assessed using the criteria of the Cochrane Back Review Group. Quality of evidence was graded according to the GRADE approach. Two review authors independently selected studies, assessed risk of bias, and extracted data. Results and upper bounds of confidence intervals were compared with predefined clinically relevant differences.

Results. We included 7 randomized controlled trials with a follow-up of 24 months. There is risk of bias in the included studies due to sponsoring and absence of any kind of blinding. One study compared disc replacement with rehabilitation and found a signifi cant advantage in favor of surgery, which, however, did not reach the predefi ned threshold. Six studies compared disc replacement with fusion and found that the mean improvement in visual analogue scale score of back pain was 5.2 mm higher (2 studies; 95% confidence interval 0.2–10.3) with a low quality of evidence. The improvement of Oswestry disability index score at 24 months in the disc replacement group was 4.3 points more than in the fusion group (5 studies; 95% confidence interval 1.85–6.68) with a low quality of evidence. Both upper bounds of the confidence intervals were below the predefined clinically relevant difference.

Conclusion. Although statistically significant, the differences in clinical improvement were not beyond generally accepted boundaries for clinical relevance. Prevention of adjacent level disease and/or facet joint degeneration was not properly assessed. Therefore, because we think that harm and complications may occur after some years, the spine surgery community should be prudent to adopt this technology on a large scale, despite the fact that total disc replacement seems to be effective in treating low back pain in selected patients, and in the short term is at least equivalent to fusion surgery.

Key words: s.

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Motion Preservation and Clinical Outcome of Porous Coated Motion Cervical Disk Arthroplasty

Neurosurgery 71:30–37, 2012 DOI: 10.1227/NEU.0b013e31824e512e

Artificial cervical disk replacements are commonly used to treat radiculomyelopathy caused by degenerative disk disease. However, long-term disk mobility and an effect on adjacent segment disease have yet to be demonstrated. We report improvements in clinical outcome after disk replacement but also demonstrate potential limitations.

OBJECTIVE: To review clinical and radiological outcomes after diskectomy and disk replacement with the Porous Coated Motion (PCM) artificial cervical disk.

METHODS: A retrospective review was done of consecutive patients who underwent 1- or 2-level PCM disk replacements. The following criteria were studied: arm pain, neck pain, Neck Disability Index and Short Form-36 questionnaires, and flexion-extension radiographs up to 2 years after surgery.

RESULTS: Eighty PCM artificial disks were implanted in 53 patients. Only 17 disks (21%) maintained physiological movement, and complete fusion was seen in 18.8%. One disk replacement was revised because of anterior displacement. There were no complications of infection, cerebrospinal fluid leak, dysphagia, or hoarse voice. Arm and neck pain improved significantly after diskectomy, but Neck Disability Index questionnaires demonstrated a slight improvement that was not sustained by 2 years. Short Form-36 scores demonstrated a trend toward better outcome with time, but it was significant only for the mental domain.

CONCLUSION: Clinical improvement was seen after PCM disk replacement, but adequate range of movement was sustained in only 21% of disk replacements over time. Unclear long-term results of this and other disk replacements suggest caution in adopting these new devices as the gold standard.

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Assessment of adjacent-segment mobility after cervical disc replacement versus fusion: RCT with 1 year’s results

Eur Spine J (2011) 20:934–941. DOI 10.1007/s00586-010-1588-2

Disc prostheses have been designed to restore and maintain cervical segmental motion and reduce the accelerated degeneration of the adjacent level. There is no knowledge about the reaction of the neighboured asymptomatic segments after implantation of prostheses or fusion. The effects of these procedures to segmental movement of the uninvolved vertebrae have not been subjected to studies so far.

The objective of this study was to compare the segmental motion following cervical disc replacement versus fusion and the correlation to the clinical outcome. Another aim was to compare the segmental motion of the asymptomatic segments above the treated ones and to compare both with Roentgen stereometric analysis (RSA) including the asymptomatic segments.

20 patients with one-level cervical radiculopathy scheduled for surgery were randomized to arthroplasty (10 patients, study group) or anterior cervical discectomy and fusion (10 patients, control group). Clinical results were evaluated using Visual Analogue Scale and Neck Disability Index. RSA was performed immediately postoperative, after 6 and 12 months.

The adjacent segment showed a significantly higher segmental motion in all three-dimensional axes in comparison to the segment treated with prostheses (P< 0.05). In the fusion group the segmental motion of the adjacent segment was significantly higher in all three dimensional axes (P< 0.05) at each examination time. When the adjacent level of both groups is compared, the fusion group could show a higher segmental motion in all three-dimensional axes, but without significant difference (P> 0.05) 1 year after surgery. Regarding the clinical results, there was no significant difference in pain relief between both groups (P> 0.05).

In conclusion, the adjacent segment could show a higher segmental motion, when compared with the segment either treated with prostheses or fusion. There was no significant difference in segmental motion adjacent to prosthesis or fusion. Clinical results did also show no significant difference in pain relief between both groups.

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Lumbar total disc replacement from an extreme lateral approach: clinical experience with a minimum of 2 years’ follow-up

J Neurosurg Spine 14:38–45, 2011. (DOI: 10.3171/2010.9.SPINE09865)

Current lumbar total disc replacement (TDR) devices require an anterior approach for implantation. This approach has inherent limitations, including risks to abdominal structures and the need for resection of the anterior longitudinal ligament (ALL). Placement of a TDR device from a true lateral (extreme lateral interbody fusion [XLIF]) approach is thought to offer a less invasive option to access the disc space, preserving the stabilizing ligaments and avoiding scarring of anterior vasculature. In this study, the authors attempted to quantify the clinical and radiographic outcomes of a lateral approach to lumbar TDR from a prospective, single-center experience.

Methods. A TDR device designed for implantation through a true lateral, retroperitoneal, transpsoas approach (XLIF) was implanted in 36 patients with discography-confirmed 1- or 2-level degenerative disc disease. Clinical (pain and function) and radiographic (range of motion [ROM]) data were prospectively collected preoperatively, postoperatively, and serially for a minimum of 24 months’ follow-up.

Results. Thirty-six surgeries were performed in 16 men and 20 women (mean age 42.6 years). Surgeries included 15 single-level TDR procedures at L3–4 or L4–5, three 2-level TDR procedures spanning L3–4 and L4–5, and 18 hybrid procedures (anterior lumbar interbody fusion [ALIF]) at L5–S1 and TDR at L4–5 [17] or L3–4 [1]). Operative time averaged 130 minutes, with an average blood loss of 60 ml and no intraoperative complications. Postoperative radiographs showed good device placement. All patients were walking within 12 hours of surgery and all but 9 were discharged the next day (7 of 9 had hybrid TDR/ALIF procedures). Five patients (13.8%) had psoas weakness and 3 (8.3%) had anterior thigh numbness postoperatively, both resolving within 2 weeks. One patient (2.8%) demonstrated weakness of the leg ipsilateral to the approach side, which lasted through the 3-month visit but was resolved by the 6-month visit. One patient (2.8%) was found to have hypertrophy of the quadriceps contralateral to the approach side at the 12-month visit, which was resolved by the 2-year visit. Four patients (11%) had postoperative facet joint pain, all in hybrid cases. All patients were 2 years or more postsurgery as of this writing, although 3 were lost to follow-up between the 1- and 2-year visits. In 2 cases (5.6%), removal of the TDR device and revision to fusion were required due to unresolved pain. At 2 years’ follow-up, the average visual analog scale and Oswestry Disability Index scores had improved 69.6% and 61.4%, respectively, and ROM averaged 8.6°, well within physiological norms.

Conclusions. Long-term results of a laterally placed TDR device demonstrate maintenance of pain relief and functional improvement. The benefits of this technique—minimal morbidity, avoiding mobilization of the great vessels, preserving the ALL, biomechanically stable orientation, and broader revision options—suggest a promising new direction for TDR procedures.

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No Justification for Cervical Disk Prostheses in Clinical Practice: A Meta-Analysis of Randomized Controlled Trials

Neurosurgery 66:1153-1160, 2010 DOI: 10.1227/01.NEU.0000369189.09182.5F

A meta-analysis was performed to evaluate whether a beneficial clinical effect of cervical disk prostheses over conventional cervical diskectomy with fusion exists.

METHODS: A literature search was completed ending February 4, 2009, that included the abstract books of recent major spine congresses. All studies reported the results of singlelevel cervical disease without myelopathy. The Visual Analog Score (VAS) of the arm, VAS of the neck, Neck Disability Index, Physical Composite Scores of the Short Form 36, and Mental Composite Score of the Short Form 36, as well as adverse events, were evaluated.

RESULTS: Nine records were found, totaling 1533 patients. Of these, 1165 were evaluable at the last follow-up at 12 or 24 months. As an effect measure, a pooled odds ratio (OR) was calculated at 12 and 24 months. At 12 months, the VAS arm reached statistical significance (OR = 0.698; 95% confidence interval [CI], 0.571-0.853), as did the VAS neck (OR = 0.690; 95% CI, 0.562-0.847), and the Physical Composite Scores (OR = 1.362; 95% CI, 1.103-1.682) and the Mental Composite Score (OR = 1.270; 95% CI, 1.029-1.569) of the Short Form 36, favoring arthroplasty. The Neck Disability Index at 24 months also reached statistical difference (OR = 0.794; 95% CI, 0.641-0.984). All other measurements did not reveal any statistical difference. The number of complications, including secondary surgeries for adjacent segment disease, did not differ.

CONCLUSION: A clinical benefit for the cervical disk prosthesis is not proven. Because none of the studies were blinded, bias of the patient or researcher is a probable explanation for the differences found. Therefore, these costly devices should not be used in daily clinical practice.

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Radiologically documented adjacent-segment degeneration after cervical arthroplasty

Surgical Neurology 72 (2009) 325–329. doi:10.1016/j.surneu.2009.02.013

Background: The authors retrospectively studied the incidence and characteristics of radiologically documented adjacent-segment degeneration after single-level diskectomy and subsequent cervical arthroplasty using the Bryan (Medtronic Sofamor Danek; Memphis, TN) disk prosthesis.

Methods: Seventy-two patients with single-level arthroplasty using the Bryan cervical disk prosthesis were evaluated. Radiological evidence of adjacent-disk disease included new formation or enlargement of anterior osteophyte, new or increasing ALL calcification, or narrowing of disk space documented on serial plain radiographs. We reported the characteristics of adjacent-segment degeneration and reviewed all of the cases.

Results: Among the 72 patients, 9 patients (12.5%) showed radiological evidence of adjacentsegment degeneration. The mean age was 43.3 years old, with a male-female ratio 1:3. The mean follow-up period was 24.2 (12.1-35.9) months. The mean period of onset was 16.3 months. Uppersegment degeneration was documented in 4 cases (3 new osteophyte, 1 enlargement of osteophyte), whereas lower-segment degeneration was noted in 5 cases (1 new osteophyte, 3 enlargement of osteophyte, 1 decreased disk height). Among the degenerated cases, 4 cases (44.4%) also showed various degrees of HO.

Conclusions: The rate of adjacent-segment degeneration was higher than that observed in previous studies. Adjacent-segment degeneration documented a tendency toward HO. A longer follow-up period is necessary to investigate and document the different types of degeneration seen at levels adjacent to artificial Bryan cervical disk prostheses.

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