A randomized prospective study of an anterior cervical interbody fusion device with a minimum of 2 years of follow-up results

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.

1994 ◽  
Vol 80 (1) ◽  
pp. 16-19 ◽  
Author(s):  
Toyohiko Isu ◽  
Kyosuke Kamada ◽  
Nobuaki Kobayashi ◽  
Shoji Mabuchi

✓ The authors describe the surgical technique of anterior cervical fusion using bone grafts obtained from cervical vertebral bodies. This series consisted of 90 patients with cervical intervertebral disc disease suffering from cervical spondylotic myelopathy. Thirty-five patients were operated on at one level, 33 at two levels, and 22 at three levels. Postoperative x-ray films showed solid bone fusion in all patients at a mean follow-up time of 24 months (range 1 year to 3 years 6 months). Anterior angulation was found in four (4.4%) of the 90 patients. This surgical procedure has two major advantages: 1) there are no complications related to the iliac donor site, allowing early patient mobilization; and 2) the extensive posterior spur can be removed safely and easily under a wide operative field without damaging the spinal cord and nerve roots.


2002 ◽  
Vol 97 (2) ◽  
pp. 186-192 ◽  
Author(s):  
Gary W. Tye ◽  
R. Scott Graham ◽  
William C. Broaddus ◽  
Harold F. Young

Object. Bone grafts used in anterior cervical fusion (ACF) may subside postoperatively. The authors reviewed a recent series in which instrument-assisted ACF was performed to determine the degree of subsidence with respect to fusion length, use of segmental screws, and patient smoking status, age, and sex. Methods. Charts and implant records were reviewed for all 70 patients who underwent instrument-assisted ACF during a 2-year period. The procedures, grafting materials, plate types/lengths, and patient smoking status were recorded. The immediate postoperative and follow-up lateral radiographs were analyzed. The plate lengths and lengths of the fused segments were measured in a standardized fashion. The mean intraoperative and follow-up fusion segment lengths were 54.3 and 51.9 mm, respectively. Greater subsidence occurred in multilevel fusions than in single-level fusions. There were noticeable changes in the position of plates or screws on 14 of 70 follow-up x-ray films. No new neurological deficits related to graft subsidence occurred, and the reoperation rate was 3%. There was no statistical relation between subsidence and the following variables: segmental fixation, smoking status, sex, age, or dowel size when corrected for length of the plate. Hardware migration correlated significantly with plate length in cases of two- and three-level fusions. Conclusions. The length of a fusion segment decreases in the immediate weeks following instrument-assisted ACF. Construct length is the most important determinant of subsidence. When designing multilevel cervical constructs, consideration of the effects of graft subsidence may help to avoid hardware-related complications.


2001 ◽  
Vol 94 (1) ◽  
pp. 174-178 ◽  
Author(s):  
Kaushik Das ◽  
William T. Couldwell ◽  
Gerard Sava ◽  
Rudolph F. Tadonio

✓ After performing anterior cervical corpectomy or discectomy for cervical spondolytic myelopathy or radiculopathy, iliac crest bone graft and fibular auto- or allograft is often used to achieve arthrodesis in the cervical spine. The purpose of this study was to evaluate the use of a cylindrical titanium mesh and locking plate system as an alternative technique in achieving anterior cervical fusion and maintaining lordosis. Hospital records and radiographs of 38 patients who underwent anterior cervical discectomies (28 patients) or corpectomies (10 patients) from 1995 to 1997 were reviewed retrospectively. All patients had undergone arthrodesis in which autograft and a cylindrical titanium mesh and anterior locking plate fixation were used after discectomy or corpectomy. There were 20 men and 18 women (mean age 46.1 years; range 34–72 years). Presenting symptoms included radiculopathy (61%), myelopathy (37%), and neck pain (2%). Preoperative and postoperative radiographs were studied, and data were obtained on the following: overall lordosis or kyphosis of the cervical spine, segmental lordosis or kyphosis at each surgically treated level, and evidence of fusion. In all of the patients in whom lordosis was present preoperatively, lordosis was maintained during the follow-up period. The overall fusion rate was 100%. The average change in overall lordosis or kyphosis related to the fixation devices was 1.2° (range 1–5°); the average segmental change was 2.3° (range 0–5°); and the mean follow up was 16 months (range 12–36 months). Anterior cervical fusion with cylindrical titanium mesh and cervical locking plate system is an effective method of achieving arthrodesis and maintaining alignment in the cervical spine. The construct may provide additional load-sharing function, and it avoids the use of cadaveric bone or the need for harvesting tricortical iliac crest autograft.


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.


1978 ◽  
Vol 48 (5) ◽  
pp. 809-810 ◽  
Author(s):  
Arden F. Reynolds ◽  
Paul T. Turner ◽  
John D. Loeser

✓ A case is presented in which fracture of the right anterior superior iliac spine occurred 2 weeks after the right iliac crest had been used as the donor site for a two-level anterior discectomy and fusion.


2005 ◽  
Vol 3 (5) ◽  
pp. 335-341 ◽  
Author(s):  
Lali H. S. Sekhon ◽  
William Sears ◽  
Neil Duggal

Object. The potential role of cervical arthroplasty in patients who have undergone previous cervical surgery is unknown. The authors performed a prospective study involving nonrandomized clinical and radiological assessment in patients who had undergone either previous posterior cervical foraminotomy or anterior interbody fusion and who suffered new or persistent arm/neck symptoms related to neural compression. Methods. During a 30-month period, 15 patients who had previously undergone cervical spinal surgery underwent cervical arthroplasty that involved placement of the Bryan disc for neck or arm symptoms related to cervical disc disease. A total of 24 devices were implanted. Six of the 15 patients had undergone a previous posterior foraminotomy, and in nine cases an anterior interbody fusion had been perfomed at some stage prior to surgery. Clinical and radiological evaluations were performed preoperatively and after surgery to assess outcomes. A total of 24 arthroplasties were performed encompassing between one and three levels. There were no major perioperative complications or immediate device-related failures. Two patients were lost to follow up. The follow-up period ranged from 12 to 43 months (mean 24.2 ± 10.5 months). Good results were obtained in all cases as reflected by an increase in the visual analog scale score of 6.4 in terms of neck/arm pain (p < 0.05). There was no difference in Oswestry Disability Index scores for neck pain (p > 0.05) and no patient required surgery at the same level. In one patient hypermobility developed with internal subluxation of the device, which suggested a compromise adjacent to a two-level fusion at 21 months. The segment was hypermobile preoperatively. The patient has experienced recurrent neck pain but otherwise remains clinically well and has not required revision surgery to date. Conclusions. Insertion of the Bryan artificial cervical disc in patients who have previously undergone cervical fusion or posterior foraminotomy, in general, appears to be safe. It provided encouraging early clinical results, although patients with preoperative hypermobility should be treated with caution. Issues such as accelerated device-related wear and the use of arthroplasty after aggressive facetectomy resection will need further study; however, in carefully selected patients who have undergone previous surgery cervical arthroplasty may provide an additional tool in the management of cervical disc disease.


2004 ◽  
Vol 1 (1) ◽  
pp. 19-23 ◽  
Author(s):  
Praveen V. Mummaneni ◽  
Jeff Pan ◽  
Regis W. Haid ◽  
Gerald E. Rodts

Object. The authors compared fusion rates in transforaminal lumbar interbody fusion (TLIFs) when using either autograft or bone morphogenetic protein (BMP) placed in the interbody space. Methods. Between September 2002 and December 2003, the authors performed 44 TLIF operations. Follow-up data were available for 40 patients. Of the 40 procedures, 19 involved cages filled with iliac crest autograft (Group 1) and 21 involved cages filled with a medium kit of recombinant human (rh) BMP-2 (Group 2). In all Group 2 patients, one BMP sponge was placed anterior to the cage and another was placed within the cage. In 12 of the Group 2 patients, iliac crest autograft was placed posterior to the BMP-filled cage (Group 2A). In the remaining nine Group 2 patients, only local autograft was placed posterior to the BMP-filled cage (Group 2B). Assessment of fusion was performed using dynamic radiography at 3-month intervals. Outcomes were assessed using the Prolo Scale, and iliac crest donor site pain was measured using a Visual Analog Scale (VAS). The mean follow-up period was 9 months (range 3–18 months). In Group 1 patients, one pseudarthrosis was detected. In Group 2 patients, dynamic radiography demonstrated solid fusion in all patients except one in Group 2B. Fiftyeight percent of patients in whom iliac crest autograft was used complained of donor site pain 6 months after surgery (5 of 10 points on the VAS). Symptomatic foraminal bone formation was not observed in any Group 2 patient. Conclusions. The use of rhBMP-2 is safe in TLIFs when the sponges are placed away from the dura mater, and BMP promotes a more rapid fusion than iliac crest autograft alone. The use of rhBMP-2 in combination with local autograft is an excellent option for promoting solid fusion with TLIF, and it eliminates the possibility of iliac donor site pain.


2002 ◽  
Vol 97 (3) ◽  
pp. 350-354 ◽  
Author(s):  
Takashiro Ohyama ◽  
Yoshichika Kubo ◽  
Hiroo Iwata ◽  
Waro Taki

Object. An interbody fusion cage has been introduced for cervical anterior interbody fusion. Autogenetic bone is packed into the cage to increase the rate of union between adjacent vertebral bodies. Thus, donor site—related complications can still occur. In this study a synthetic ceramic, β—tricalcium phosphate (TCP), was examined as a substitute for autograft bone in a canine lumbar spine model. Methods. In 12 dogs L-1 to L-4 vertebrae were exposed via a posterolateral approach, and discectomy and placement of interbody fusion cages were performed at two intervertebral disc spaces. One cage was filled with autograft (Group A) and the other with TCP (Group B). The lumbar spine was excised at 16 weeks postsurgery, and biomechanical, microradiographic, and histological examinations were performed. Both the microradiographic and histological examinations revealed that fusion occurred in five (41.7%) of 12 operations performed in Group A and in six (50%) of 12 operations performed in Group B. The mean percentage of trabecular bone area in the cages was 54.6% in Group A and 53.8% in Group B. There were no significant intergroup differences in functional unit stiffness. Conclusions. Good histological and biomechanical results were obtained for TCP-filled interbody fusion cages. The results were comparable with those obtained using autograft-filled cages, suggesting that there is no need to harvest iliac bone or to use allo- or xenografts to increase the interlocking strength between the cage and vertebral bone to achieve anterior cervical interbody fusion.


1990 ◽  
Vol 73 (2) ◽  
pp. 193-200 ◽  
Author(s):  
Dennis A. Turner ◽  
Jay Tracy ◽  
Stephen J. Haines

✓ The long-term outcome following carotid endarterectomy for neurological symptoms was analyzed using a retrospective life-table approach in 212 patients who had undergone 243 endarterectomy procedures. The postoperative follow-up period averaged 38.9 ± 2.1 months (mean ± standard error of the mean). The endpoints of stroke and death were evaluated in these patients. Patient groups with the preoperative symptoms of amaurosis fugax, transient ischemic attack, and prior recovered stroke were similar in terms of life-table outcome over the follow-up period. Sixty-two percent of symptomatic patients were alive and free of stroke at 5 years. The late risk of stroke (after 30 days postoperatively) averaged 1.7% per year based on a linear approximation to the hazard at each life-table interval (1.3% per year for ipsilateral stroke). The trend of late stroke risk was clearly downward, however, and could be fitted more accurately by an exponential decay function with a half-life of 33 months. Thus, the risk of stroke following carotid endarterectomy for neurological symptoms was highest in the perioperative period, slowly declined with time, and occurred predominantly ipsilateral to the procedure. The definition of a prospective medical control group remains crucial for a critical analysis of treatment modalities following the onset of premonitory neurological symptoms. In the absence of an adequate control group for this series, the calculated perioperative and postoperative stroke risk from this study was compared to data obtained from the literature on stroke risk in medically treated symptomatic patients. This uncontrolled comparison of treatment modalities suggests the combined perioperative and postoperative stroke risk associated with carotid endarterectomy to be modestly improved over medical treatment alone.


2002 ◽  
Vol 97 (4) ◽  
pp. 464-467 ◽  
Author(s):  
Thomas G. Lowe ◽  
Jeffrey D. Coe

Object. Sixty patients underwent instrumentation-assisted posterior transforaminal lumbar interbody fusion (TLIF) with resorbable polymer cages and autograft bone for degenerative disease. This article discusses the technique of TLIF and its early outcomes. Methods. Although the follow-up period is short and results are preliminary, no adverse events or complications were attributed to the resorbable polymer. Conclusions. Further multicenter clinical studies are underway with a minimum 2-year follow-up period chosen as an endpoint to provide insight as to the future of biodegradable polymers as spinal interbody devices.


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