Contribution of recombinant human bone morphogenetic protein—2 to the rapid creation of interbody fusion when used in transforaminal lumbar interbody fusion: a preliminary report

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.

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.


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.


2005 ◽  
Vol 3 (6) ◽  
pp. 436-443 ◽  
Author(s):  
Alan T. Villavicencio ◽  
Sigita Burneikiene ◽  
E. Lee Nelson ◽  
Ketan R. Bulsara ◽  
Mark Favors ◽  
...  

Object. Recombinant human bone morphogenetic protein—2 (rhBMP-2) is being increasingly used for spinal fusion. There are few data regarding its clinical safety, effectiveness, and clinical outcome when applied on an absorbable collagen sponge (ACS) in conjunction with allograft for transforaminal lumbar interbody fusion (TLIF). Methods. Seventy-four consecutive patients undergoing TLIF for degenerative disc disease were divided into five groups depending on whether the patient underwent a minimally invasive or open approach, as well as the number of spinal levels surgically treated. Surgery-related data, fusion results, complications, and clinical outcome were evaluated. The mean follow-up duration was 20.6 months (range 14–28 months). The radiographic fusion rate was 100% at 12 and 24 months after the surgery. No bone overgrowth or other complications related to BMP use were demonstrated. Conclusions. Analysis of the results demonstrated that TLIF combined with a BMP-2—soaked ACS is a feasible, effective, and safe method to promote lumbar fusion. There were no significant intergroup differences in clinical outcome between patients who underwent open compared with minimally invasive procedures. Patient satisfaction rates, however, were higher in the minimally invasive procedure group. The efficacy of BMP-2 was not dependent on which approach was used or the number of spinal levels that were treated.


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.


Neurosurgery ◽  
2002 ◽  
Vol 50 (3) ◽  
pp. 510-517 ◽  
Author(s):  
Robert F. Heary ◽  
Richard P. Schlenk ◽  
Theresa A. Sacchieri ◽  
Dean Barone ◽  
Cristian Brotea

1998 ◽  
Vol 88 (2) ◽  
pp. 255-265 ◽  
Author(s):  
Paul D. Sawin ◽  
Vincent C. Traynelis ◽  
Arnold H. Menezes

Object. Autogeneic bone graft is often incorporated into posterior cervical stabilization constructs as a fusion substrate. Iliac crest is used frequently, although donor-site morbidity can be substantial. Rib is used rarely, despite its accessibility, expandability, unique curvature, and high bone morphogenetic protein content. The authors present a comparative analysis of autogeneic rib and iliac crest bone grafts, with emphasis on fusion rate and donor-site morbidity. Methods. A review was conducted of records and radiographs from 600 patients who underwent cervical spinal fusion procedures in which autogeneic bone grafts were used. Three hundred patients underwent rib harvest and posterior cervical fusion. The remaining 300 patients underwent iliac crest harvest (248 for an anterior cervical fusion and 52 for posterior fusion). The analysis of fusion focused on the latter subgroup; donor-site morbidity was determined by evaluating the entire group. Fusion criteria included bony trabeculae traversing the donor—recipient interface and long-term stability on flexion—extension radiographs. Graft morbidity was defined as any untoward event attributable to the graft harvest. Statistical comparisons were facilitated by using Fisher's exact test. Conclusions. Demographic data obtained in both groups were comparable. Rib constructs were placed in the following regions: occipitocervical (196 patients), atlantoaxial (35 patients), and subaxial cervical spine (69 patients). Iliac crest grafts were placed in the occipitocervical (28 patients), atlantoaxial (10 patients), and subaxial cervical (14 patients) regions. Fusion occurred in 296 (98.8%) of 300 rib graft and 49 (94.2%) of 52 iliac crest graft constructs (p = 0.056). Graft morbidity was greater with iliac crest than with rib (p < 0.00001). Donor-site morbidity for the rib graft was 3.7% and included pneumonia (eight patients), persistent atelectasis (two patients), and superficial wound dehiscence (one patient). Pneumothorax, intercostal neuralgia, and chronic chest wall pain were not encountered. Iliac crest morbidity occurred in 25.3% of the patients and consisted of chronic donor-site pain (52 patients), wound dehiscence (eight patients), pneumonia (seven patients), meralgia paresthetica (four patients), hematoma requiring evacuation (three patients), and iliac spine fracture (two patients). Even when chronic pain was not considered, morbidity encountered in obtaining iliac crest still exceeded that encountered with rib harvest (p = 0.035). The fusion rate and donor-site morbidity for rib autograft compare favorably with those for iliac crest when used in posterior cervical constructs. To the authors' knowledge, this represents the largest series to date in which the safety and efficacy of using autogeneic bone graft materials in spinal surgery are critically analyzed.


2004 ◽  
Vol 1 (1) ◽  
pp. 87-89 ◽  
Author(s):  
Dean Chou ◽  
Phillip B. Storm ◽  
James N. Campbell

Object. Autologous bone graft harvesting from the iliac crest remains the gold standard for fusion surgery. One disadvantage of autologous bone harvesting is the patient's enduring postoperative pain at the donor site. Nerve injury is one of the postulated mechanisms that may account for this pain. The object of this study was to determine whether the lateral cutaneous branch of the subcostal nerve is vulnerable to injury in the process of obtaining grafts from the anterior iliac crest. Methods. Anatomical dissections were performed on 10 cadaveric specimens to ascertain the size of the T-12 subcostal nerve and its position in relation to the iliac crest. Conclusions. The lateral cutaneous branch of the subcostal nerve may lie as close as 6 cm from the anterior superior iliac spine. This nerve is very vulnerable to injury when harvesting bone from the anterior iliac crest. Knowledge of the anatomy may decrease the risk of injury to this nerve.


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