An H S, Simpson J M, Glover J M, Stephany J
Department of Orthopaedic Surgery, Medical College of Wisconsin, Milwaukee, USA.
Spine (Phila Pa 1976). 1995 Oct 15;20(20):2211-6.
This study analyzed the fusion results of an allograft-demineralized bone matrix composite versus autograft in a prospective series of patients undergoing surgery for cervical disc disease.
To determine the fusion rates of allograft-demineralized bone matrix composite in anterior cervical fusion as compared with the gold standard autograft.
For the anterior cervical fusion, the use of freeze-dried allograft is well documented in the literature, citing its effectiveness and inferior fusion rates. The use of demineralized bone matrix in conjunction with freeze-dried allograft in anterior cervical fusion has not been reported.
This study was done in a prospective fashion in two medical centers. One group received autograft from the anterior iliac crest, whereas others received freeze-dried allograft augmented with demineralized bone matrix (Grafton, Osteotech, Inc., Shrewsbury, New Jersey). For the autograft group, the standard Smith-Robinson grafting technique was used. For the allograft composite group, demineralized bone matrix was pasted onto the freeze-dried allograft and into the disc space before graft insertion. The autograft group consisted of 38 patients with age ranging 26-71 years (mean, 46.1 years) and follow-up periods of 12-33 months (mean, 18.4 months). There were 19 one-level, 17 two-level, and two three-level fusions. Similarly, the allograft group consisted of 39 patients with age ranging 28-80 years (mean, 48.0 years) with follow-up period of 12-31 months (mean, 17.5 months). There were 19 one-level, 16 two-level, and four three-level fusions. Clinical and radiographic follow-up evaluations were completed at 3-month intervals. Radiographs taken 12 months after surgery were analyzed blindly.
Pseudarthrosis developed in 46.2% of patients (33.3% of levels) in the allograft-demineralized bone matrix group compared with 26.3% (22% of levels) in the autograft group (P = 0.11 for patients, P = 0.23 for levels). For patients undergoing two-level fusions, 37.5% of allograft-demineralized bone matrix failed compared with 23.5% of autografts. For single-level fusions, 47.4% of allograft patients developed a pseudarthrosis compared with 26.3% in the autograft group. Graft collapse of > or = 3 mm was noted in 11% of the autograft group versus 19% in the allograft-demineralized bone matrix group (P = 0.32). Graft collapse of > or = 2 mm occurred in 24.4% of autograft patients compared with 39.7% of the allograft-demineralized bone matrix group (P = 0.09). Smokers had an increased rate of pseudarthrosis (47.1%) compared with nonsmokers (27.9%, P = 0.13).
The study revealed that the allograft-demineralized bone matrix construct gives a higher rate of graft collapse and pseudarthrosis when compared with autograft in a prospective series, although the differences were not statistically significant. The pseudarthrosis rate in the series may be high because of the large percentage of smokers and radiographic evaluation techniques. For the purpose of solid radiographic fusion, the use of autograft is recommended in anterior cervical surgery until other acceptable osteoinductive materials are developed.
本研究以前瞻性方式分析了同种异体脱矿骨基质复合材料与自体骨在一系列接受颈椎疾病手术患者中的融合结果。
确定同种异体脱矿骨基质复合材料在前路颈椎融合中的融合率，并与金标准自体骨进行比较。
关于前路颈椎融合，文献中充分记载了冻干同种异体骨的使用情况，提及了其有效性及较低的融合率。但前路颈椎融合中联合使用脱矿骨基质与冻干同种异体骨的情况尚未见报道。
本研究在两个医疗中心以前瞻性方式进行。一组接受取自髂嵴的自体骨，而其他组接受添加了脱矿骨基质的冻干同种异体骨（Grafton，Osteotech公司，新泽西州什鲁斯伯里）。对于自体骨组，采用标准的史密斯-罗宾逊植骨技术。对于同种异体骨复合材料组，在植入移植物前，将脱矿骨基质粘贴到冻干同种异体骨上并填入椎间盘间隙。自体骨组有38例患者，年龄在26 - 71岁之间（平均46.1岁），随访期为12 - 33个月（平均18.4个月）。其中有19例单节段融合、17例双节段融合和2例三节段融合。同样地，同种异体骨组有39例患者，年龄在28 - 80岁之间（平均48.0岁），随访期为12 - 31个月（平均17.5个月）。其中有19例单节段融合、16例双节段融合和4例三节段融合。临床和影像学随访评估每3个月进行一次。对术后12个月拍摄的X线片进行盲法分析。
同种异体脱矿骨基质组46.2%的患者（33.3%的节段）出现假关节形成，而自体骨组为26.3%（22%的节段）（患者P值 = 0.11，节段P值 = 0.23）。对于接受双节段融合的患者，同种异体脱矿骨基质组有37.5%失败，而自体骨组为23.5%。对于单节段融合，同种异体骨组47.4%的患者出现假关节形成，而自体骨组为26.3%。自体骨组11%出现≥3 mm的移植物塌陷，同种异体脱矿骨基质组为19%（P = 0.32）。自体骨组24.4%的患者出现≥2 mm的移植物塌陷，同种异体脱矿骨基质组为39.7%（P = 0.09）。吸烟者假关节形成率（47.1%）高于非吸烟者（2,7.9%，P = 0.13）。
该研究表明，在前瞻性系列研究中，与自体骨相比，同种异体脱矿骨基质构建物的移植物塌陷和假关节形成率更高，尽管差异无统计学意义。由于吸烟者比例较大和影像学评估技术的原因，该系列中的假关节形成率可能较高。为实现可靠的影像学融合，在前路颈椎手术中建议使用自体骨，直至开发出其他可接受的骨诱导材料。
