Cervical disc arthroplasty: a controlled randomized prospective study with intermediate follow-up results

2005 ◽  
Vol 3 (6) ◽  
pp. 424-428 ◽  
Author(s):  
Robert J. Hacker

Object. The authors of studies of anterior cervical fusion for disc-related disease have documented satisfying clinical results and infrequent complications. Recently, cervical disc arthroplasty has entered clinical trials as an alternative to fusion. Although the results of anecdotal reports and prospective studies support this procedure, these studies have not conferred the validity of a controlled randomized study. In the present study, the author presents data obtained in such a study. Methods. After symptoms failed to respond to conservative therapy, 46 patients with one-level discogenic cervical radiculopathy and/or myelopathy were randomized to undergo arthroplasty or fusion as part of a US Food and Drug Administration medical device study. In all patients there was a minimum follow-up duration of 1 year. Equivalent results for the relief of arm pain and neck pain were noted in both treatment groups. Treatment parameters other than operative time were similar. No neurological or serious systemic complications occurred. Conclusions. Although extended follow-up data and larger patient populations are needed, the results of this study indicate that arthroplasty is a viable alternative to cervical fusion.

2016 ◽  
Vol 24 (5) ◽  
pp. 752-759 ◽  
Author(s):  
Peng-Yuan Chang ◽  
Hsuan-Kan Chang ◽  
Jau-Ching Wu ◽  
Wen-Cheng Huang ◽  
Li-Yu Fay ◽  
...  

OBJECTIVE Several large-scale clinical trials demonstrate the efficacy of 1- and 2-level cervical disc arthroplasty (CDA) for degenerative disc disease (DDD) in the subaxial cervical spine, while other studies reveal that during physiological neck flexion, the C4–5 and C5–6 discs account for more motion than the C3–4 level, causing more DDD. This study aimed to compare the results of CDA at different levels. METHODS After a review of the medical records, 94 consecutive patients who underwent single-level CDA were divided into the C3–4 and non-C3–4 CDA groups (i.e., those including C4–5, C5–6, and C6–7). Clinical outcomes were measured using the visual analog scale for neck and arm pain and by the Japanese Orthopaedic Association scores. Postoperative range of motion (ROM) and heterotopic ossification (HO) were determined by radiography and CT, respectively. RESULTS Eighty-eight patients (93.6%; mean age 45.62 ± 10.91 years), including 41 (46.6%) female patients, underwent a mean follow-up of 4.90 ± 1.13 years. There were 11 patients in the C3–4 CDA group and 77 in the non-C3–4 CDA group. Both groups had significantly improved clinical outcomes at each time point after the surgery. The mean preoperative (7.75° vs 7.03°; p = 0.58) and postoperative (8.18° vs 8.45°; p = 0.59) ROMs were similar in both groups. The C3–4 CDA group had significantly greater prevalence (90.9% vs 58.44%; p = 0.02) and higher severity grades (2.27 ± 0.3 vs 0.97 ± 0.99; p = 0.0001) of HO. CONCLUSIONS Although CDA at C3–4 was infrequent, the improved clinical outcomes of CDA were similar at C3–4 to that in the other subaxial levels of the cervical spine at the approximately 5-year follow-ups. In this Asian population, who had a propensity to have ossification of the posterior longitudinal ligament, there was more HO formation in patients who received CDA at the C3–4 level than in other subaxial levels of the cervical spine. While the type of artificial discs could have confounded the issue, future studies with more patients are required to corroborate the phenomenon.


2000 ◽  
Vol 93 (2) ◽  
pp. 222-226 ◽  
Author(s):  
Robert J. Hacker

Object. Despite variations in technique, inherent problems persist with current approaches to anterior cervical fusion. This study was performed to determine whether anterior cervical fusion performed using an investigational device was safe and effective in the treatment of degenerative cervical disc disorders and whether this device offered advantages over current techniques. Methods. Fifty-four patients with radiculopathy with or without mild myelopathy due to one- or two-level cervical degenerative disc disease were randomized as part of a Food and Drug Administration device study. Following microsurgical discectomy, the control group was treated with iliac crest graft fusion; the experimental study group underwent insertion of an interspace cage and placement of a local autograft. All patients received postoperative follow-up care for at least 2 years. Good or excellent results were found in approximately 97% of the experimental group and 88% of the control group. A solid fusion was achieved in all patients who underwent one-level cage placement, and a solid fusion at one or both levels was achieved in over 90% of both groups. Chronic donor site pain was reported by 31% of the control group. Conclusions. In this study, the use of an interbody fusion cage avoided donor site morbidity and placement of autograft achieved a high rate of good or excellent results. Interbody fusion cages appear safe and effective, and their use helps to avoid some of the inherent problems in performing current anterior cervical fusion techniques.


2005 ◽  
Vol 3 (6) ◽  
pp. 417-423 ◽  
Author(s):  
James T. Robertson ◽  
Stephen M. Papadopoulos ◽  
Vincent C. Traynelis

Object. The authors compared the incidence of radiologically documented changes and symptomatic adjacent-level cervical disc disease after single-level discectomy and subsequent cervical fusion or arthroplasty in two independent prospective clinical studies. Methods. The patients were treated with the Affinity Anterior Cervical Cage System or the Bryan Artificial Cervical Disc. In each study the patients were required to undergo serial cervical radiography preoperatively and 24 months postoperatively, as well as serial clinical evaluations including documentation of adverse events, neurological status, and results of the 36-item Short Form Health Survey. All serial radiographs were reviewed prior to evaluating the clinical symptoms for development of increasing or new adjacent degenerative disc disease (DDD). Subsequently, the clinical data were analyzed. For various reasons of exclusion, the cases analyzed in the Bryan disc—treated cohort consisted of 74 patients and in the Affinity system—treated cohort there were 158 patients. New anterior osteophyte formation or enlargement, increased narrowing of an interspace, new DDD, and calcification of the anterior longitudinal ligament were the radiological findings indicative of adjacent-level disease. Fusion was associated with a significant increase in x-ray film—based changes of adjacent-disc disease (p = 0.009, odds ratio [OR] 2.44). In the cage fusion series, the incidence of symptomatic adjacent-level DDD was statistically greater than that in the group treated with the artificial disc (p = 0.018), and the patients required a statistically greater number of medical treatments related to episodic symptoms of neck, shoulder, and arm pain attributed to new disc disease (p = 0.001, OR 35.8). Conclusions. In comparing these prospective studies the authors demonstrated that maintaining motion rather than fusion will prevent symptomatic adjacent-disc disease and will decrease adjacent-level radiological indicators of disease at a 24-month postoperative interval.


2020 ◽  
Vol 32 (2) ◽  
pp. 174-181 ◽  
Author(s):  
Hsuan-Kan Chang ◽  
Wen-Cheng Huang ◽  
Tsung-Hsi Tu ◽  
Li-Yu Fay ◽  
Chao-Hung Kuo ◽  
...  

OBJECTIVEOne- and two-level cervical disc arthroplasty (CDA) has been compared to anterior cervical discectomy and fusion (ACDF) in several large-scale, prospective, randomized trials that have demonstrated similar clinical outcomes. However, whether these results would be similar when treating 3-level disc herniation and/or spondylosis has remained unanswered. This study aimed to investigate the differences between 3-level CDA and ACDF.METHODSA series of 50 patients who underwent 3-level CDA at C3–7 was retrospectively reviewed and compared with another series of 50 patients (age- and sex-matched controls) who underwent ACDF at C3–7. Clinical outcomes were measured using the visual analog scale (VAS) for neck and arm pain, the modified Japanese Orthopaedic Association (mJOA) scale, and the Neck Disability Index (NDI). Radiological outcomes included range of motion (ROM) at the index levels. Every patient was evaluated by CT for the presence of fusion in the ACDF group. Also, complication profiles were investigated.RESULTSThe demographics and levels of distribution in both groups were very similar. During the follow-up period of 24 months, clinical outcomes improved (overall and respectively in each group) for both the CDA and ACDF patients when compared with the patients’ preoperative condition. There were essentially few differences between the two groups in terms of neck and arm pain VAS scores, mJOA scores, and NDI scores preoperatively and at 3, 6, 12, and 24 months postoperatively. After the 3-level surgery, the CDA group had an increased mean ROM of approximately 3.4°, at 25.2° ± 8.84°, compared to their preoperative ROM (21.8° ± 7.20°) (p = 0.001), whereas the ACDF group had little mobility (22.8° ± 5.90° before and 1.0° ± 1.28° after surgery; p < 0.001). The mean operative time, estimated blood loss, and complication profiles were similar for both groups.CONCLUSIONSIn this selectively matched retrospective study, clinical outcomes after 3-level CDA and ACDF were similar during the 2-year follow-up period. CDA not only successfully preserved but slightly increased the mobility at the 3 index levels. However, the safety and efficacy of 3-level CDA requires more long-term data for validatation.


2019 ◽  
Vol 30 (2) ◽  
pp. 168-174 ◽  
Author(s):  
Tsung-Hsi Tu ◽  
Chao-Hung Kuo ◽  
Wen-Cheng Huang ◽  
Li-Yu Fay ◽  
Henrich Cheng ◽  
...  

OBJECTIVECigarette smoking can adversely affect bone fusion in patients who undergo anterior cervical discectomy and fusion. However, there is a paucity of data on smoking among patients who have undergone cervical disc arthroplasty (CDA). The present study aimed to compare the clinical and radiological outcomes of smokers to those of nonsmokers following CDA.METHODSThe authors retrospectively reviewed the records of consecutive patients who had undergone 1- or 2-level CDA for cervical disc herniation or spondylosis and had a minimum 2-year follow-up. All patients were grouped into a smoking group, which consisted of those who had consumed cigarettes within 6 months prior to the CDA surgery, or a nonsmoking group, which consisted of those who had not consumed cigarettes at all or within 6 months of the CDA. Clinical outcomes were evaluated according to the visual analog scale for neck and arm pain, Neck Disability Index, Japanese Orthopaedic Association Scale, and Nurick Scale at each time point of evaluation. Radiological outcomes were assessed using radiographs and CT for multiple parameters, including segmental range of motion (ROM), neutral lordotic curve, and presence of heterotopic ossification (HO).RESULTSA total of 109 patients completed at least 2 years of follow-up and were analyzed (mean follow-up 42.3 months). There were 89 patients in the nonsmoking group and 20 in the smoking group. The latter group was younger and predominantly male (both p < 0.05) compared to the nonsmoking group. The two groups had similar improvements in all clinical outcomes after CDA compared to preoperatively. Radiological evaluations were also very similar between the two groups, except for two factors. The smoking group had well-preserved segmental ROM after CDA at an average of 8.1° (both pre- and postoperation). However, while the nonsmoking group remained mobile, segmental ROM decreased significantly (8.2° to 6.9°, p < 0.05) after CDA. There was a trend toward more HO development in the nonsmoking group than in the smoking group, but the difference was without significance (59.6% vs 50.0%, p = 0.43).CONCLUSIONSDuring an average 3.5 years of follow-up after 1- and 2-level CDA, cigarette smokers and nonsmokers had similar improvements in clinical outcomes. Moreover, segmental mobility was slightly better preserved in smokers. Since smoking status did not negatively impact outcomes, CDA may be a reasonable option for selected patients who have smoked.


2017 ◽  
Vol 42 (2) ◽  
pp. E5 ◽  
Author(s):  
Deshpande V. Rajakumar ◽  
Akshay Hari ◽  
Murali Krishna ◽  
Subhas Konar ◽  
Ankit Sharma

OBJECTIVE Adjacent-level disc degeneration following cervical fusion has been well reported. This condition poses a major treatment dilemma when it becomes symptomatic. The potential application of cervical arthroplasty to preserve motion in the affected segment is not well documented, with few studies in the literature. The authors present their initial experience of analyzing clinical and radiological results in such patients who were treated with arthroplasty for new or persistent arm and/or neck symptoms related to neural compression due to adjacent-segment disease after anterior cervical discectomy and fusion (ACDF). METHODS During a 5-year period, 11 patients who had undergone ACDF anterior cervical discectomy and fusion (ACDF) and subsequently developed recurrent neck or arm pain related to adjacent-level cervical disc disease were treated with cervical arthroplasty at the authors' institution. A total of 15 devices were implanted (range of treated levels per patient: 1–3). Clinical evaluation was performed both before and after surgery, using a visual analog scale (VAS) for pain and the Neck Disability Index (NDI). Radiological outcomes were analyzed using pre- and postoperative flexion/extension lateral radiographs measuring Cobb angle (overall C2–7 sagittal alignment), functional spinal unit (FSU) angle, and range of motion (ROM). RESULTS There were no major perioperative complications or device-related failures. Statistically significant results, obtained in all cases, were reflected by an improvement in VAS scores for neck/arm pain and NDI scores for neck pain. Radiologically, statistically significant increases in the overall lordosis (as measured by Cobb angle) and ROM at the treated disc level were observed. Three patients were lost to follow-up within the first year after arthroplasty. In the remaining 8 cases, the duration of follow-up ranged from 1 to 3 years. None of these 8 patients required surgery for the same vertebral level during the follow-up period. CONCLUSIONS Artificial cervical disc replacement in patients who have previously undergone cervical fusion surgery appears to be safe, with encouraging early clinical results based on this small case series, but more data from larger numbers of patients with long-term follow-up are needed. Arthroplasty may provide an additional tool for the management of post-fusion adjacent-level cervical disc disease in carefully selected patients.


1973 ◽  
Vol 38 (6) ◽  
pp. 679-683 ◽  
Author(s):  
Francis Murphey ◽  
James C. H. Simmons ◽  
Bruce Brunson

✓ From the analysis of 648 patients operated on for ruptured cervical discs between 1939 and March of 1972 and a follow-up study of 380 of these patients, the following conclusions seem justified. Osteophytes or hypertrophic spurs rarely produced the classical clinical picture or deficits. Ninety per cent of the patients awakened in the morning with pain in the neck and rhomboid region. Ten per cent had a history of injury, but there was no characteristic pattern as in lumbar discs. Only one patient had a typical hyperextension injury. Anterior chest pain occurred in one-fifth of the cases. Pain in the neck, rhomboid region, and anterior chest was referred from the discs, while the arm pain was usually the result of nerve root compression; however, in a few cases the degenerating disc caused referred pain to the arm without any nerve root pressure. Since accurate diagnosis can be made on clinical grounds, myelography is not necessary in most cases. In our experience conservative treatment was usually unsuccessful while the surgical results were better than in almost any other neurosurgical operation. The nerve root syndromes associated with extruded lateral cervical discs are outlined and the indications and contraindications for myelography discussed.


10.14444/7036 ◽  
2020 ◽  
Vol 14 (3) ◽  
pp. 269-277 ◽  
Author(s):  
PIERCE D. NUNLEY ◽  
EUBULUS J. KERR ◽  
DAVID A. CAVANAUGH ◽  
PHILLIP ANDREW UTTER ◽  
PETER G. CAMPBELL ◽  
...  

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