Abstract
Purpose
A variety of bone substitutes have been successfully used to fill PEEK cages in cervical interbody fusion in order to avoid the complications related to bone harvesting from the donor site. However, no controlled study has previously been conducted to compare the effectiveness of PEEK interbody cages containing calcium sulphate/ demineralized bone matrix (CS/DBM) with autogenous cancellous bone for the treatment of cervical spondylosis. The objective of this prospective, randomized clinical study was to evaluate the effectiveness of implanting PEEK cages containing CS/DBM for the treatment of cervical radiculopathy and/or myelopathy.
Methods
Sixty-eight patients with cervical radiculopathy and/or myelopathy were randomly assigned to receive one- or two-level discectomy and fusion with PEEK interbody cages containing CS/DBM or autogenous iliac cancellous bone (AIB). The patients were followed up for two years postoperatively. The radiological and clinical outcomes were assessed during a two-year follow-up.
Results
The mean blood loss was 75 ± 18.5 ml in the CS/DBM group and 100 ± 19.6 ml (P < 0.01) in the AIB group. The fusion rate was 94.3 % in the CS/DBM group and 100 % in the AIB group at 12-month follow-up. The fusion rate was 100 % at final follow-up in both groups. No significant difference (P > 0.05) was found regarding improvement of JOA score and segmental lordosis as well as neck and arm pain at all time intervals between the two groups. The total complication rate was significantly higher (P < 0.05) in the AIB group than in the CS/DBM group, but there was no significant difference between the two groups (P > 0.05) when comparing the complications in the neck.
Conclusions
In conclusion, the PEEK interbody fusion cage containing CS/DBM or AIB following one- or two-level discectomy had a similar outcome for cervical spondylotic radiculopathy and/or myelopathy. The rate of fusion and the recovery rate of JOA score between the two groups were the same. The filling of CS/DBM in the PEEK cage instead of AIB has the advantage of less operative blood loss and fewer complications at the donor site.
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References
Cloward RB (1958) The anterior approach for removal of ruptured cervical disks. J Neurosurg 15:602–617
Smith GW, Robinson RA (1958) The treatment of certain cervical-spine disorders by anterior removal of the intervertebral disc and interbody fusion. J Bone Joint Surg Am 40-A:607–624
Banwart JC, Asher MA, Hassanein RS (1995) Iliac crest bone graft harvest donor site morbidity. A statistical evaluation. Spine (Phila Pa 1976) 20:1055–1060
Vaccaro AR, Singh K, Haid R, Kitchel S, Wuisman P, Taylor W, Branch C, Garfin S (2003) The use of bioabsorbable implants in the spine. Spine J 3:227–237
Vavruch L, Hedlund R, Javid D, Leszniewski W, Shalabi A (2002) A prospective randomized comparison between the Cloward procedure and a carbon fiber cage in the cervical spine: a clinical and radiologic study. Spine (Phila Pa 1976) 27:1694–1701
Song KJ, Lee KB (2006) A preliminary study of the use of cage and plating for single-segment fusion in degenerative cervical spine disease. J Clin Neurosci 13:181–187
Liao JC, Niu CC, Chen WJ, Chen LH (2008) Polyetheretherketone (PEEK) cage filled with cancellous allograft in anterior cervical discectomy and fusion. Int Orthop 32:643–648
Dai LY, Jiang LS (2008) Anterior cervical fusion with interbody cage containing beta-tricalcium phosphate augmented with plate fixation: a prospective randomized study with 2-year follow-up. Eur Spine J 17:698–705
Cho DY, Lee WY, Sheu PC, Chen CC (2005) Cage containing a biphasic calcium phosphate ceramic (Triosite) for the treatment of cervical spondylosis. Surg Neurol 63:497–503, discussion 503–494
Topuz K, Colak A, Kaya S, Simsek H, Kutlay M, Demircan MN, Velioglu M (2009) Two-level contiguous cervical disc disease treated with peek cages packed with demineralized bone matrix: results of 3-year follow-up. Eur Spine J 18:238–243
Scholz M, Schleicher P, Eindorf T, Friedersdorff F, Gelinsky M, Konig U, Sewing A, Haas NP, Kandziora F (2010) Cages augmented with mineralized collagen and platelet-rich plasma as an osteoconductive/inductive combination for interbody fusion. Spine (Phila Pa 1976) 35:740–746
Dickerman RD, Reynolds AS, Morgan B (2008) Polyetheretherketone (PEEK) cage filled with bone morphogenic protein and demineralised bone matrix in anterior cervical discectomy and fusion. Int Orthop 32:717
Alderman NE (1969) Sterile plaster of Paris as an implant in the infrabony environment: a preliminary study. J Periodontol 40:11–13
Feng Y, Wang S, Jin D, Sheng J, Chen S, Cheng X, Zhang C (2011) Free vascularised fibular grafting with OsteoSet(R)2 demineralised bone matrix versus autograft for large osteonecrotic lesions of the femoral head. Int Orthop 35:475–481
Niu CC, Tsai TT, Fu TS, Lai PL, Chen LH, Chen WJ (2009) A comparison of posterolateral lumbar fusion comparing autograft, autogenous laminectomy bone with bone marrow aspirate, and calcium sulfate with bone marrow aspirate: a prospective randomized study. Spine (Phila Pa 1976) 34:2715–2719
Katz JM, Nataraj C, Jaw R, Deigl E, Bursac P (2009) Demineralized bone matrix as an osteoinductive biomaterial and in vitro predictors of its biological potential. J Biomed Mater Res B Appl Biomater 89:127–134
McKee MD (2006) Management of segmental bony defects: the role of osteoconductive orthobiologics. J Am Acad Orthop Surg 14:S163–S167
Peterson B, Whang PG, Iglesias R, Wang JC, Lieberman JR (2004) Osteoinductivity of commercially available demineralized bone matrix. Preparations in a spine fusion model. J Bone Joint Surg Am 86-A:2243–2250
Pietrzak WS, Perns SV, Keyes J, Woodell-May J, McDonald NM (2005) Demineralized bone matrix graft: a scientific and clinical case study assessment. J Foot Ankle Surg 44:345–353
Wang JC, Alanay A, Mark D, Kanim LE, Campbell PA, Dawson EG, Lieberman JR (2007) A comparison of commercially available demineralized bone matrix for spinal fusion. Eur Spine J 16:1233–1240
Sampath P, Bendebba M, Davis JD, Ducker TB (2000) Outcome of patients treated for cervical myelopathy. A prospective, multicenter study with independent clinical review. Spine (Phila Pa 1976) 25:670–676
Anderson PA, Subach BR, Riew KD (2009) Predictors of outcome after anterior cervical discectomy and fusion: a multivariate analysis. Spine (Phila Pa 1976) 34:161–166
Grossman W, Peppelman WC, Baum JA, Kraus DR (1992) The use of freeze-dried fibular allograft in anterior cervical fusion. Spine (Phila Pa 1976) 17:565–569
Young WF, Rosenwasser RH (1993) An early comparative analysis of the use of fibular allograft versus autologous iliac crest graft for interbody fusion after anterior cervical discectomy. Spine (Phila Pa 1976) 18:1123–1124
Boakye M, Mummaneni PV, Garrett M, Rodts G, Haid R (2005) Anterior cervical discectomy and fusion involving a polyetheretherketone spacer and bone morphogenetic protein. J Neurosurg Spine 2:521–525
Moore R, Beredjiklian P, Rhoad R, Theiss S, Cuckler J, Ducheyne P, Baker DG (1997) A comparison of the inflammatory potential of particulates derived from two composite materials. J Biomed Mater Res 34:137–147
Pechlivanis I, Thuring T, Brenke C, Seiz M, Thome C, Barth M, Harders A, Schmieder K (2011) Non-fusion rates in anterior cervical discectomy and implantation of empty polyetheretherketone cages. Spine (Phila Pa 1976) 36:15–20
Cho DY, Liau WR, Lee WY, Liu JT, Chiu CL, Sheu PC (2002) Preliminary experience using a polyetheretherketone (PEEK) cage in the treatment of cervical disc disease. Neurosurgery 51:1343–1349, discussion 1349–1350
Einhorn TA, Lane JM, Burstein AH, Kopman CR, Vigorita VJ (1984) The healing of segmental bone defects induced by demineralized bone matrix. A radiographic and biomechanical study. J Bone Joint Surg Am 66:274–279
Lee KJ, Roper JG, Wang JC (2005) Demineralized bone matrix and spinal arthrodesis. Spine J 5:217S–223S
Miyazaki M, Tsumura H, Wang JC, Alanay A (2009) An update on bone substitutes for spinal fusion. Eur Spine J 18:783–799
Cheung S, Westerheide K, Ziran B (2003) Efficacy of contained metaphyseal and periarticular defects treated with two different demineralized bone matrix allografts. Int Orthop 27:56–59
Russell JL, Block JE (1999) Clinical utility of demineralized bone matrix for osseous defects, arthrodesis, and reconstruction: impact of processing techniques and study methodology. Orthopedics 22:524–531, quiz 532–523
Peltier LF (1959) The use of plaster of Paris to fill large defects in bone. Am J Surg 97:311–315
Tay BK, Patel VV, Bradford DS (1999) Calcium sulfate- and calcium phosphate-based bone substitutes. Mimicry of the mineral phase of bone. Orthop Clin N Am 30:615–623
Kim CK, Kim HY, Chai JK, Cho KS, Moon IS, Choi SH, Sottosanti JS, Wikesjo UM (1998) Effect of a calcium sulfate implant with calcium sulfate barrier on periodontal healing in 3-wall intrabony defects in dogs. J Periodontol 69:982–988
Kim CK, Chai JK, Cho KS, Moon IS, Choi SH, Sottosanti JS, Wikesjo UM (1998) Periodontal repair in intrabony defects treated with a calcium sulfate implant and calcium sulfate barrier. J Periodontol 69:1317–1324
Peters CL, Hines JL, Bachus KN, Craig MA, Bloebaum RD (2006) Biological effects of calcium sulfate as a bone graft substitute in ovine metaphyseal defects. J Biomed Mater Res A 76:456–462
Lillo R, Peltier LF (1956) The substitution of plaster of Paris rods for portions of the diaphysis of the radius in dogs. Surg Forum 6:556–558
Lee GH, Khoury JG, Bell JE, Buckwalter JA (2002) Adverse reactions to OsteoSet bone graft substitute, the incidence in a consecutive series. Iowa Orthop J 22:35–38
Kelly CM, Wilkins RM, Gitelis S, Hartjen C, Watson JT, Kim PT (2001) The use of a surgical grade calcium sulfate as a bone graft substitute: results of a multicenter trial. Clin Orthop Relat Res 382:42–50
Acknowledgments
This work was supported by the National Natural Science Foundation of China (81071453), the project administrated by Shanghai Science and Technology Committee (13DZ1940802 & 14441901700), the Program for Innovative Research Team of Shanghai Municipal Education Commission, and the Fund for Interdisciplinary Research on Medicine and Engineering of Shanghai Jiaotong University (YG2011MS24). No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.
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The authors declare that they have no conflict of interest.
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Youzhuan XIE and Hua LIcontributed equally to this work.
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Xie, Y., Li, H., Yuan, J. et al. A prospective randomized comparison of PEEK cage containing calcium sulphate or demineralized bone matrix with autograft in anterior cervical interbody fusion. International Orthopaedics (SICOT) 39, 1129–1136 (2015). https://doi.org/10.1007/s00264-014-2610-9
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DOI: https://doi.org/10.1007/s00264-014-2610-9