J Neurosurg Spine 37:569–578, 2022
Anterior cervical discectomy and fusion (ACDF) has long been regarded as a gold standard in the treatment of cervical myelopathy. Subsequently, cervical artificial disc replacement (c-ADR) was developed and provides the advantage of motion preservation at the level of the intervertebral disc surgical site, which may also reduce stress at adjacent levels. The goal of this study was to compare clinical and functional outcomes in patients undergoing ACDF with those in patients undergoing c-ADR for cervical spondylotic myelopathy (CSM).
METHODS A systematic literature review and meta-analysis were performed using the Embase, PubMed, and Cochrane Central Register of Controlled Trials databases from database inception to November 21, 2021. The authors compared Neck Disability Index (NDI), SF-36, and Japanese Orthopaedic Association (JOA) scores; complication rates; and reoperation rates for these two surgical procedures in CSM patients. The Mantel-Haenszel method and varianceweighted means were used to analyze outcomes after identifying articles that met study inclusion criteria.
RESULTS More surgical time was consumed in the c-ADR surgery (p = 0.04). Shorter hospital stays were noted in patients who had undergone c-ADR (p = 0.04). Patients who had undergone c-ADR tended to have better NDI scores (p = 0.02) and SF-36 scores (p = 0.001). Comparable outcomes in terms of JOA scores (p = 0.24) and neurological success rate (p = 0.12) were noted after the surgery. There was no significant between-group difference in the overall complication rates (c-ADR: 18% vs ACDF: 25%, p = 0.17). However, patients in the ACDF group had a higher reoperation rate than patients in the c-ADR group (4.6% vs 1.5%, p = 0.02).
CONCLUSIONS At the midterm follow-up after treatment of CSM, better functional outcomes as reflected by NDI and SF-36 scores were noted in the c-ADR group than those in the ACDF group. c-ADR had the advantage of retaining range of motion at the level of the intervertebral disc surgical site without causing more complications. A large sample size with long-term follow-up studies may be required to confirm these findings in the future.
Prospective, single-site, randomized, Food and Drug Administration–approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices.
Objective. To evaluate complications with CA occurring more than 4 years after the surgical procedure in Food and Drug Administration clinical trials of the Bryan and Prestige LP arthroplasty devices. Summary of Background Data. Reports of several randomized clinical studies have shown CA to be a safe and effective alternative to anterior cervical fusion in the treatment of degenerative cervical disc disorders. A majority include follow-up intervals of 4 years or less.
Methods. Between 2002 and 2006, 94 patients were enrolled in Food and Drug Administration studies of the Bryan and Prestige LP cervical disc devices. Charts, imaging studies, and hospital records were reviewed for those who underwent arthroplasty and returned more than 4 years after their surgical procedure with neck-related pain or dysfunction. Results. Excluding adjacent segment disease that occurred with a similar rate for patients who underwent fusion and arthroplasty, 5 patients, all treated with arthroplasty, returned for evaluation of neck and arm symptoms between 48 and 72 months after surgery. Four patients had peridevice vertebral body bone loss. One patient had posterior device migration and presented with myelopathy. Three required revision surgery and 2 were observed. Four patients maintained follow-up and reported stabilization or improvement in symptoms.
Conclusion. Despite their similarities, CA and fusion are not equivalent procedures in this study in regard to very late complications. Similar to large joint arthroplasty, delayed devicerelated complications may occur with CA. These complications commenced well beyond the time frame for complications associated with more traditional cervical spine procedures. Both patients and surgeons should be aware of the potential for very late device-related complications occurring with CA and the need for revision surgery.
Level of Evidence: 1
J Neurosurg Spine 16:594–600, 2012. (http://thejns.org/doi/abs/10.3171/2012.2.SPINE111066)
The most currently accepted indication for cervical arthroplasty is 1- or 2-level degenerative disc disease (DDD) refractory to medical treatment. However, the randomized and controlled clinical trials by the US FDA investigational device exemption studies only compared cervical arthroplasty with anterior cervical discectomy and fusion for 1-level disease. Theoretically, 2-level cervical spondylosis usually implicates more advanced degeneration, whereas the 1-level DDD can be caused by merely a soft-disc herniation. This study aimed to investigate the differences between 1- and 2-level cervical arthroplasty.
Methods. The authors analyzed data obtained in 87 consecutive patients who underwent 1- or 2-level cervical arthroplasty with Bryan disc. The patients were divided into the 1-level and the 2-level treatment groups. Clinical outcomes were measured using the visual analog scale (VAS) for the neck and arm pain and the Neck Disability Index (NDI), with a minimum follow-up of 30 months. Radiographic outcomes were evaluated on both radiographs and CT scans.
Results. The study analyzed 98 levels of Bryan cervical arthroplasty in 70 patients (80.5%) who completed the evaluations in a mean follow-up period of 46.21 ± 9.85 months. There were 22 females (31.4%) and 48 males (68.6%), whose mean age was 46.57 ± 10.07 years at the time of surgery. The 1-level group had 42 patients (60.0%), while the 2-level group had 28 patients (40.0%). Patients in the 1-level group were younger than those in the 2-level group (mean 45.00 vs 48.93 years, p = 0.111 [not significant]). Proportional sex compositions and perioperative prescription of nonsteroidal antiinflammatory drugs were also similar in both groups (p = 0.227 and p = 1.000). The 2-level group had significantly greater EBL during surgery than the 1-level group (220.80 vs 111.89 ml, p = 0.024). Heterotopic ossification was identified more frequently in the 2-level group than the 1-level group (75.0% vs 40.5%, p = 0.009). Although most of the artificial discs remained mobile during the follow up, the 2-level group had fewer mobile discs (100% and 85.7%, p = 0.022) than the 1-level group. However, in both groups, the clinical outcomes measured by VAS for neck pain, VAS for arm pain, and NDI all significantly improved after surgery compared with that preoperatively, and there were no significant differences between the groups at any point of evaluation (that is, at 3, 6, 12, and 24 months after surgery).
Conclusions. Clinical outcomes of 1- and 2-level cervical arthroplasty were similar at 46 months after surgery, and patients in both groups had significantly improved compared with preoperative status. However, there was a significantly higher rate of heterotopic ossification formation and less mobility of the Bryan disc in patients who underwent 2-level arthroplasty. Although mobility to date has been maintained in the vast majority (94.3%) of patients, the long-term effects of heterotopic ossification warrant further investigation.
J Neurosurg Spine 16:216–228, 2012. DOI: 10.3171/2011.6.SPINE10623
There are now 3 randomized, multicenter, US FDA investigational device exemption, industry-sponsored studies comparing arthroplasty with anterior cervical discectomy and fusion (ACDF) for single-level cervical disease with 2 years of follow-up. These 3 studies evaluated the Prestige ST, Bryan, and ProDisc-C artificial discs. The authors analyzed the combined results of these trials.
Methods. A total of 1213 patients with symptomatic, single-level cervical disc disease were randomized into 2 treatment arms in the 3 randomized trials. Six hundred twenty-one patients received an artificial cervical disc, and 592 patients were treated with ACDF. In the three trials, 94% of the arthroplasty group and 87% of the ACDF group have completed 2 years of follow-up. The authors analyzed the 2-year data from these 3 trials including previously unpublished source data. Statistical analysis was performed with fixed and random effects models.
Results. The authors’ analysis revealed that segmental sagittal motion was preserved with arthroplasty (preoperatively 7.26° and postoperatively 8.14°) at the 2-year time point. The fusion rate for ACDF at 2 years was 95%. The Neck Disability Index, 36-Item Short Form Health Survey Mental, and Physical Component Summaries, neck pain, and arm pain scores were not statistically different between the groups at the 24-month follow-up. The arthroplasty group demonstrated superior results at 24 months in neurological success (RR 0.595, I2 = 0%, p = 0.006). The arthroplasty group had a lower rate of secondary surgeries at the 2-year time point (RR 0.44, I2 = 0%, p = 0.004). At the 2-year time point, the reoperation rate for adjacent-level disease was lower for the arthroplasty group when the authors analyzed the combined data set using a fixed effects model (RR 0.460, I2 = 2.9%, p = 0.030), but this finding was not significant using a random effects model. Adverse event reporting was too heterogeneous between the 3 trials to combine for analysis.
Conclusions. Both anterior cervical discectomy and fusion as well as arthroplasty demonstrate excellent 2-year surgical results for the treatment of 1-level cervical disc disease with radiculopathy. Arthroplasty is associated with a lower rate of secondary surgery and a higher rate of neurological success at 2 years. Arthroplasty may be associated with a lower rate of adjacent-level disease at 2 years, but further follow-up and analysis are needed to confirm this finding.
J Neurosurg Spine 15:630–635, 2011.DOI: 10.3171/2011.8.SPINE11273
Cervical arthroplasty has emerged as a means of preventing adjacent segment disease by preserving motion, restoring sagittal balance, and mimicking natural spinal kinematics. The purpose of this retrospective in vivo study was to characterize the impact of arthroplasty on sagittal balance and segmental kinematics of the cervical spine.
Methods. Sixty patients receiving the Bryan disc, ProDisc-C, or Prestige LP disc were retrospectively analyzed. Only single-level arthroplasty cases were included in this study. Lateral dynamic radiographs of the cervical spine were evaluated using quantitative measurement analysis software to determine the kinematics at the index level both preoperatively and 1 year postoperatively. Collected parameters included range of motion (ROM), disc angles, shell angles, anterior and posterior disc heights (ADHs/PDHs), translation, and center of rotation (COR). Preoperative and postoperative data were compared using the Student t-test, with p < 0.05 indicating significance.
Results. The Bryan and Prestige LP discs preserved motion, whereas the ProDisc-C increased segmental ROM from extension to flexion. Following surgery, the Bryan disc exhibited significant shell angle kyphosis, while Pro- Disc-C and Prestige LP retained lordosis. Both ADHs and PDHs decreased following insertion of the Bryan disc. In contrast, the ProDisc-C increased the ADHs and PDHs by 80% and 52%, respectively, and the Prestige LP disc increased the ADHs and PDHs by 20%. Only the ProDisc-C demonstrated significant translation of 0.7 mm. The ProDisc-C shifted the COR x by 0.9 mm anteriorly, while the Prestige LP disc demonstrated a significant superior shift of 2.2 mm in COR y.
Conclusions. All discs adequately maintained ROM at the surgical level. The greatest difference among the 3 devices was in the disc height and index angle measurements
J Spinal Disord Tech 2010;23:367–371
Study Design: Prospective, randomized, controlled. Level 1 evidence.
Objective: To report functional outcomes at 48 months followup on prospectively randomized patients to either the Bryan cervical disc prosthesis or anterior cervical discectomy and fusion (ACDF) at a single site.
Summary of Background Data: Surgical treatment of cervical disc pathology can involve discectomy and fusion (ACDF), the gold standard technique. The safety and effectiveness of this procedure has been established and demonstrated in the literature, however, limitations have evolved and alternatives such as disc replacement are being investigated. Intervertebral disc replacement is designed to preserve motion, both at affected and adjacent levels avoiding limitations of fusion such as adjacent level degeneration. New onset degenerative changes and possible recurring neurologic symptoms may be deferred or eliminated with cervical disc replacement. A recent multicenter trial with 24 months follow-up has shown the Bryan disc to compare favorably with ACDF. Continued follow-up is needed to further evaluate and compare functional outcomes in both these cohorts.
Methods: A total of 47 patients were enrolled at our site as part of an ongoing multicenter prospectively randomized study investigating ACDF versus Bryan cervical disc prosthesis. Functional outcomes are now reported at 48 months follow-up for our cohort of participants. Neck disability index score (NDI), VAS neck and arm and SF-36 both physical and mental as well as complications and reoperations will be reported.
Results: Functional outcome data collected at routine follow-up for 48-months has favorably demonstrated improved functional outcomes for NDI, neck/arm pain VAS scores, and the SF-36 physical/mental health component scores for the Bryan arthroplasty and ACDF cohorts. The NDI scores for the Bryan arthroplasty preoperatively was 51 and at 48 months 10. For ACDF preoperative NDI score was also 51 and at 48 months 16.7. At 48 months NDI success, measured by Z15 points NDI improvement demonstrated a 93.3% success for Bryan arthroplasty and an 82.4%success for ACDF. VAS neck pain scores for the Bryan arthroplasty preoperatively was 76.2 and at 48 months was 13.6. VAS neck pain scores for ACDF preoperatively was 80.6 and at 48 months was 28.1. Arm Pain scores were also measured and for the Bryan arthroplasty preoperatively measured 78.8 and at 48 months 10.8. For ACDF arm pain scores preoperatively measured 77.1 and at 48 months 21.7. These outcomes have not been associated with any degradation of outcome measures from 2 to 4 years. During the 48 months of follow-up at our institution we also report 6 secondary surgeries in our control group (ACDF) and only 1 in our investigational group (Bryan). Of the 6 surgeries in the control group performed, 3 or 12% to date were for adjacent level degenerative disease and 1 or 4% for remote level degenerative disc disease. The remaining 2 surgeries were performed on the same patient for a pseudarthrosis. In the investigational group there was only 1 secondary surgery performed to date for adjacent level disease 5%.
Conclusions: At 48 months, cervical arthroplasty with the Bryan cervical disc prosthesis continues to compare favorably to ACDF at our institution. There has been no degradation of functional outcomes from 24 to 48 months for NDI, VAS of neck and arm, and SF-36. There has been a lower incidence of secondary surgeries for the Bryan arthroplasty cohort to date.
Neurosurg Focus 28 (6):E5, 2010. DOI: 10.3171/2010.3.FOCUS1032
Anterior cervical discectomy and fusion had been considered a safe and effective procedure for radiculopathy and myelopathy in the cervical spine, but degeneration in adjacent spinal levels has been a problem in some patients after fusion. Since 2002, cervical disc arthroplasty has been established as an alternative to fusion. The objective of this study was to review data concerning the role of cervical arthroplasty in reducing adjacent-level degeneration.
Methods. A systematic review was performed using the MEDLINE, EMBASE, Cochrane, and LILACS databases, focusing on a structured question involving the population of interest, types of intervention, types of control, and outcomes studied.
Results. No study has specifically compared the results of arthroplasty with the results of fusion with respect to the rate of postoperative development of adjacent-segment degenerative disease. One paper described a rate for adjacent-level surgery. The level of evidence of that paper was classified 2b, and although its authors found a statistically significant between-groups difference (arthroplasty vs fusion) using log-rank analysis, re-analysis according to number needed to treat (in the current paper) did not reveal statistical significance.
Conclusions. Adjacent-level degeneration has not been adequately studied in a review of the available randomized controlled trials on this topic, and there is no clinical evidence of reduction in adjacent-level degeneration with the use of cervical arthroplasty.