메뉴 건너뛰기




Volumn 39, Issue 26, 2014, Pages 2115-2118

Scientific evaluation of spinal implants: An ethical necessity

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL EFFECTIVENESS; DECOMPRESSION SURGERY; DEVICE SAFETY; DISK PROSTHESIS; EUROPEAN UNION; EVALUATION STUDY; EVIDENCE BASED MEDICINE; FOLLOW UP; HISTORY OF MEDICINE; HUMAN; IMPLANTATION; LAW; LUMBAR SPINE; MEDICAL ETHICS; MONITORING; PEDICLE SCREW; REVIEW; SCIENTIFIC EVALUATION; SPINAL SPACER; SPINE IMPLANT; UNITED STATES;

EID: 84919426632     PISSN: 03622436     EISSN: 15281159     Source Type: Journal    
DOI: 10.1097/BRS.0000000000000671     Document Type: Review
Times cited : (16)

References (50)
  • 1
    • 79960040305 scopus 로고    scopus 로고
    • World Health Organization. Geneva, Switzerland. World Health Organization
    • World Health Organization. Medical Devices: Managing the Mismatch. Geneva, Switzerland. World Health Organization; 2010.
    • (2010) Medical Devices: Managing the Mismatch
  • 3
    • 84878327988 scopus 로고    scopus 로고
    • How can we get high quality routine data to monitor the safety of devices and procedures ?
    • Campbell B, Stainthorpe AC, Longson CM. How can we get high quality routine data to monitor the safety of devices and procedures ? BMJ 2013; 346: f2782.
    • (2013) BMJ , vol.346 , pp. f2782
    • Campbell, B.1    Stainthorpe, A.C.2    Longson, C.M.3
  • 4
    • 84872082045 scopus 로고    scopus 로고
    • The 510(k) ancestry of a metal-on-metal hip implant
    • Ardaugh BM, Graves SE, Redberg RF. The 510(k) ancestry of a metal-on-metal hip implant. N Engl J Med 2013; 368: 97-100. doi:10.1056/NEJMp1211581.
    • (2013) N Engl J Med , vol.368 , pp. 97-100
    • Ardaugh, B.M.1    Graves, S.E.2    Redberg, R.F.3
  • 5
    • 84893507564 scopus 로고    scopus 로고
    • Founder of pip breast implant company gets four year prison sentence
    • Benkimoun P. Founder of PIP breast implant company gets four year prison sentence. BMJ 2013; 347: f7528.
    • (2013) BMJ , vol.347 , pp. f7528
    • Benkimoun, P.1
  • 6
    • 65549163943 scopus 로고    scopus 로고
    • Clinical research: Is the spine fi eld a mine field ?
    • Carragee EJ, Deyo RA, Kovacs FM, et al. Clinical research: is the spine fi eld a mine fi eld ? Spine (Phila Pa 1976) 2009; 34: 423-30. doi:10.1097/BRS.0b013e318198c962.
    • (2009) Spine (Phila Pa 1976 , vol.34 , pp. 423-430
    • Carragee, E.J.1    Deyo, R.A.2    Kovacs, F.M.3
  • 7
    • 77950511365 scopus 로고    scopus 로고
    • The increasing morbidity of elective spinal stenosis surgery: Is it necessary ?
    • Carragee EJ. The increasing morbidity of elective spinal stenosis surgery: is it necessary ? JAMA 2010; 303: 1309-1310. doi:303/13/1309.
    • (2010) JAMA , vol.303 , pp. 1309-1310
    • Carragee, E.J.1
  • 8
    • 1442290042 scopus 로고    scopus 로고
    • Spinal-fusion surgery-the case for restraint
    • Deyo RA, Nachemson A, Mirza SK. Spinal-fusion surgery-the case for restraint. N Engl J Med 2004; 350: 722-6. doi:10.1056/NEJMsb031771.
    • (2004) N Engl J Med , vol.350 , pp. 722-726
    • Deyo, R.A.1    Nachemson, A.2    Mirza, S.K.3
  • 9
    • 77950477601 scopus 로고    scopus 로고
    • Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults
    • Deyo RA, Mirza SK, Martin BI, et al. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA 2010; 303: 1259-65. doi:10.1001/jama.2010.338.
    • (2010) JAMA , vol.303 , pp. 1259-1265
    • Deyo, R.A.1    Mirza, S.K.2    Martin, B.I.3
  • 10
    • 77953586233 scopus 로고    scopus 로고
    • Treatment of lumbar spinal stenosis: A balancing act
    • Deyo RA. Treatment of lumbar spinal stenosis: a balancing act. Spine J 2010; 10: 625-7. doi:10.1016/j.spinee.2010.05.006.
    • (2010) Spine J , vol.10 , pp. 625-627
    • Deyo, R.A.1
  • 11
    • 84882249606 scopus 로고    scopus 로고
    • The pip scandal: An analysis of the process of quality control that failed to safeguard women from the health risks
    • Martindale V, Menache A. The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks. J R Soc Med 2013; 106: 173-7. doi:10.1177/0141076813480994.
    • (2013) J R Soc Med , vol.106 , pp. 173-177
    • Martindale, V.1    Menache, A.2
  • 12
    • 84879520171 scopus 로고    scopus 로고
    • Review that found pip implants to be safe was fl awed, say campaigners
    • Wise J. Review that found PIP implants to be safe was fl awed, say campaigners. BMJ 2013; 346: f3034.
    • (2013) BMJ , vol.346 , pp. f3034
    • Wise, J.1
  • 13
    • 0343171584 scopus 로고
    • Council Directive 93/42/EEC. 1993. http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medicaldevices/index-en.htm
    • (1993) Council Directive 93/42/EEC
  • 14
    • 84919447646 scopus 로고    scopus 로고
    • Commission recommendation on a common framework for a unique device identifi cation system of medical devices in the union official
    • Commission recommendation on a common framework for a unique device identifi cation system of medical devices in the Union. Official J European Union. 2013.
    • (2013) J European Union
  • 15
    • 33846069116 scopus 로고    scopus 로고
    • Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial
    • Malmivaara A, Slatis P, Heliovaara M, et al. Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial. Spine (Phila Pa 1976) 2007; 32: 1-8. doi:10.1097/01. brs.0000251014.81875.6d.
    • (2007) Spine (Phila Pa 1976 , vol.32 , pp. 1-8
    • Malmivaara, A.1    Slatis, P.2    Heliovaara, M.3
  • 16
    • 84888178623 scopus 로고    scopus 로고
    • Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: Randomized controlled trial
    • Moojen WA, Arts MP, Jacobs WC, et al. Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial. BMJ 2013; 347: f6415.
    • (2013) BMJ , vol.347 , pp. f6415
    • Moojen, W.A.1    Arts, M.P.2    Jacobs, W.C.3
  • 17
    • 0026623353 scopus 로고
    • Surgery for lumbar spinal stenosis. Attempted meta-Analysis of the literature
    • Turner JA, Ersek M, Herron L, et al. Surgery for lumbar spinal stenosis. Attempted meta-Analysis of the literature. Spine (Phila Pa 1976) 1992; 17: 1-8.
    • (1992) Spine (Phila Pa 1976 , vol.17 , pp. 1-8
    • Turner, J.A.1    Ersek, M.2    Herron, L.3
  • 18
    • 34249830160 scopus 로고    scopus 로고
    • Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis
    • Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med 2007; 356: 2257-70. doi:10.1056/NEJMoa070302.
    • (2007) N Engl J Med , vol.356 , pp. 2257-2270
    • Weinstein, J.N.1    Lurie, J.D.2    Tosteson, T.D.3
  • 19
    • 0023877857 scopus 로고
    • Recalibration of the lumbar canal, an alternative to laminectomy in the treatment of lumbar canal stenosis
    • Senegas J, Etchevers JP, Vital JM, et al. Recalibration of the lumbar canal, an alternative to laminectomy in the treatment of lumbar canal stenosis. Rev Chir Orthop Reparatrice Appar Mot 1988; 74: 15-22.
    • (1988) Rev Chir Orthop Reparatrice Appar Mot , vol.74 , pp. 15-22
    • Senegas, J.1    Etchevers, J.P.2    Vital, J.M.3
  • 20
    • 0025932583 scopus 로고
    • Surgery of the intervertebral ligaments, alternative to arthrodesis in the treatment of degenerative instabilities
    • Senegas J. Surgery of the intervertebral ligaments, alternative to arthrodesis in the treatment of degenerative instabilities. Acta Orthop Belg 1991; 57 ( suppl 1 ): 221-6.
    • (1991) Acta Orthop Belg , vol.57 , pp. 221-226
    • Senegas, J.1
  • 21
    • 0036033686 scopus 로고    scopus 로고
    • Mechanical supplementation by non-rigid fi xation in degenerative intervertebral lumbar segments: The wallis system
    • Senegas J. Mechanical supplementation by non-rigid fi xation in degenerative intervertebral lumbar segments: the Wallis system. Eur Spine J 2002; 11 ( suppl 2 ): S164-9. 10.1007/s00586-002-0423-9.
    • (2002) Eur Spine J , vol.11 , pp. S164-S169
    • Senegas, J.1
  • 22
    • 0031418708 scopus 로고    scopus 로고
    • Preliminary design and experimental studies of a novel soft implant for correcting sagittal plane instability in the lumbar spine
    • Minns RJ, Walsh WK. Preliminary design and experimental studies of a novel soft implant for correcting sagittal plane instability in the lumbar spine. Spine (Phila Pa 1976). 1997; 22: 1819-25.
    • (1997) Spine (Phila Pa 1976 , vol.22 , pp. 1819-1825
    • Minns, R.J.1    Walsh, W.K.2
  • 23
    • 77950916091 scopus 로고    scopus 로고
    • Does an interspinous device (cofl ex) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients
    • Richter A, Schutz C, Hauck M, et al. Does an interspinous device (Cofl ex) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients. Eur Spine J 2009. doi:10.1007/s00586-009-1229-9.
    • (2009) Eur Spine J
    • Richter, A.1    Schutz, C.2    Hauck, M.3
  • 24
    • 49249109406 scopus 로고    scopus 로고
    • Biomechanical effect of different lumbar interspinous implants on fl exibility and intradiscal pressure
    • Wilke HJ, Drumm J, Haussler K, et al. Biomechanical effect of different lumbar interspinous implants on fl exibility and intradiscal pressure. Eur Spine J. 2008; 17: 1049-56. doi:10.1007/s00586-008-0657-2.
    • (2008) Eur Spine J , vol.17 , pp. 1049-1056
    • Wilke, H.J.1    Drumm, J.2    Haussler, K.3
  • 25
    • 10744228216 scopus 로고    scopus 로고
    • A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the x stop interspinous implant: 1-year results
    • Zucherman JF, Hsu KY, Hartjen CA, et al. A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results. Eur Spine J 2004; 13: 22-31. doi:10.1007/s00586-003-0581-4.
    • (2004) Eur Spine J , vol.13 , pp. 22-31
    • Zucherman, J.F.1    Hsu, K.Y.2    Hartjen, C.A.3
  • 26
    • 84855200644 scopus 로고    scopus 로고
    • Effectiveness of interspinous implant surgery in patients with intermittent neurogenic claudication: A systematic review and meta-Analysis
    • Moojen WA, Arts MP, Bartels RH, et al. Effectiveness of interspinous implant surgery in patients with intermittent neurogenic claudication: a systematic review and meta-Analysis. Eur Spine J 2011; 20: 1596-1606. doi:10.1007/s00586-011-1873-8.
    • (2011) Eur Spine J , vol.20 , pp. 1596-1606
    • Moojen, W.A.1    Arts, M.P.2    Bartels, R.H.3
  • 27
    • 84883445929 scopus 로고    scopus 로고
    • Decompression and cofl ex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis two-year results from the prospective, randomized, multicenter, food and drug administration investigational device exemption trial
    • Davis RJ, Errico TJ, Bae H, et al. Decompression and Cofl ex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis: two-year results from the prospective, randomized, multicenter, Food and Drug Administration Investigational Device Exemption trial. Spine (Phila Pa 1976). 2013; 38: 1529-39. doi:10.1097/BRS.0b013e31829a6d0a.
    • (2013) Spine (Phila Pa 1976 , vol.38 , pp. 1529-1539
    • Davis, R.J.1    Errico, T.J.2    Bae, H.3
  • 29
    • 77953659389 scopus 로고    scopus 로고
    • The felix-trial double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication
    • Moojen WA, Arts MP, Brand R, et al. The Felix-trial. Double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication. BMC Musculoskelet Disord 2010; 11: 100. doi:10.1186/1471-2474-11-100.
    • (2010) BMC Musculoskelet Disord , vol.11 , pp. 100
    • Moojen, W.A.1    Arts, M.P.2    Brand, R.3
  • 30
    • 84882455388 scopus 로고    scopus 로고
    • X-stop versus decompressive surgery for lumbar neurogenic intermittent claudication: Randomized controlled trial with 2-year follow-up
    • Stromqvist BH, Berg S, Gerdhem P, et al. X-Stop versus decompressive surgery for lumbar neurogenic intermittent claudication: randomized controlled trial with 2-Year follow-up. Spine (Phila Pa 1976) 2013; 38: 1436-42. doi:10.1097/BRS.0b013e31828ba413.
    • (2013) Spine (Phila Pa 1976 , vol.38 , pp. 1436-1442
    • Stromqvist, B.H.1    Berg, S.2    Gerdhem, P.3
  • 31
    • 84882455388 scopus 로고    scopus 로고
    • X-stop versus decompressive surgery for lumbar neurogenic intermittent claudication: Randomized controlled trial with 2-year follow-up
    • Stromqvist BH, Berg S, Gerdhem P, et al. X-Stop versus decompressive surgery for lumbar neurogenic intermittent claudication: randomized controlled trial with 2-year follow-up. Spine (Phila Pa 1976) 2013; 38: 1436-42.
    • (2013) Spine (Phila Pa 1976 , vol.38 , pp. 1436-1442
    • Stromqvist, B.H.1    Berg, S.2    Gerdhem, P.3
  • 32
    • 0001031265 scopus 로고
    • The treatment of ruptured lumbar intervertebral disc by vertebral body fusion. Iii. Method of use of banked bone
    • Cloward RB. The treatment of ruptured lumbar intervertebral disc by vertebral body fusion. III. Method of use of banked bone. Ann Surg 1952; 136: 987-92.
    • (1952) Ann Surg , vol.136 , pp. 987-992
    • Cloward, R.B.1
  • 33
    • 33748096662 scopus 로고
    • The treatment of ruptured lumbar intervertebral discs by vertebral body fusion. I. Indications, operative technique, after care
    • Cloward RB. The treatment of ruptured lumbar intervertebral discs by vertebral body fusion. I. Indications, operative technique, after care. J Neurosurg 1953; 10: 154-68. doi:10.3171/jns.1953.10.2.0154.
    • (1953) J Neurosurg , vol.10 , pp. 154-168
    • Cloward, R.B.1
  • 34
    • 34548661047 scopus 로고    scopus 로고
    • Posterior lumbar interbody fusion versus posterolateral fusion in adult isthmic spondylolisthesis
    • Ekman P, Moller H, Tullberg T, et al. Posterior lumbar interbody fusion versus posterolateral fusion in adult isthmic spondylolisthesis. Spine (Phila Pa 1976) 2007; 32: 2178-83. doi:10.1097/BRS.0b013e31814b1bd8.
    • (2007) Spine (Phila Pa 1976 , vol.32 , pp. 2178-2183
    • Ekman, P.1    Moller, H.2    Tullberg, T.3
  • 35
    • 33645567278 scopus 로고    scopus 로고
    • Fusion for low-grade adult isthmic spondylolis thesis a systematic review of the literature
    • Jacobs WC, Vreeling A, de Kleuver KM Fusion for low-grade adult isthmic spondylolisthesis: a systematic review of the literature. Eur Spine J 2006; 15: 391-402. doi:10.1007/s00586-005-1021-4.
    • (2006) Eur Spine J , vol.15 , pp. 391-402
    • Jacobs, W.C.1    Vreeling, A.2    De Kleuver, K.M.3
  • 36
    • 84889657200 scopus 로고    scopus 로고
    • Evidence for surgery in degenerative lumbar spine disorders
    • Jacobs WC, Rubinstein SM, Koes B, et al. Evidence for surgery in degenerative lumbar spine disorders. Best Pract Res Clin Rheumatol. 2013; 27: 673-84. doi:10.1016/j.berh.2013.09.009.
    • (2013) Best Pract Res Clin Rheumatol , vol.27 , pp. 673-684
    • Jacobs, W.C.1    Rubinstein, S.M.2    Koes, B.3
  • 37
    • 84885311954 scopus 로고    scopus 로고
    • The evidence on surgical interventions for low back disorders, an overview of systematic reviews
    • Jacobs WC, Rubinstein SM, Willems PC, et al. The evidence on surgical interventions for low back disorders, an overview of systematic reviews. Eur Spine J. 2013; 22: 1936-49. doi:10.1007/s00586-013-2823-4.
    • (2013) Eur Spine J , vol.22 , pp. 1936-1949
    • Jacobs, W.C.1    Rubinstein, S.M.2    Willems, P.C.3
  • 39
    • 22644436393 scopus 로고    scopus 로고
    • A prospective, randomized, multicenter food and drug administration investigational device exemptions study of lumbar total disc replacement with the charite artifi cial disc versus lumbar fusion: Part i: Evaluation of clinical outcomes
    • Blumenthal S, McAfee PC, Guyer RD, et al. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artifi cial disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine (Phila Pa 1976) 2005; 30: 1565-75.
    • (2005) Spine (Phila Pa 1976 , vol.30 , pp. 1565-1575
    • Blumenthal, S.1    McAfee, P.C.2    Guyer, R.D.3
  • 41
    • 0016838202 scopus 로고
    • Drugs and operations some important differences
    • Love JW. Drugs and operations. Some important differences. JAMA 1975; 232: 37-8.
    • (1975) JAMA , vol.232 , pp. 37-38
    • Love, J.W.1
  • 42
    • 70349288302 scopus 로고    scopus 로고
    • Evaluation and stages of surgical innovations
    • Barkun JS, Aronson JK, Feldman LS, et al. Evaluation and stages of surgical innovations. Lancet 2009; 374: 1089-96. doi:10.1016/S0140-6736(09)61083-7.
    • (2009) Lancet , vol.374 , pp. 1089-1096
    • Barkun, J.S.1    Aronson, J.K.2    Feldman, L.S.3
  • 43
    • 70349294326 scopus 로고    scopus 로고
    • Challenges in evaluating surgical innovation
    • Ergina PL, Cook JA, Blazeby JM, et al. Challenges in evaluating surgical innovation. Lancet 2009; 374: 1097-1104. doi:10.1016/S0140-6736(09)61086-2.
    • (2009) Lancet , vol.374 , pp. 1097-1104
    • Ergina, P.L.1    Cook, J.A.2    Blazeby, J.M.3
  • 44
    • 70349280608 scopus 로고    scopus 로고
    • No surgical innovation without evaluation: The ideal recommendations
    • McCulloch P, Altman DG, Campbell WB, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009; 374: 1105-12. doi:10.1016/S0140-6736(09)61116-8.
    • (2009) Lancet , vol.374 , pp. 1105-1112
    • McCulloch, P.1    Altman, D.G.2    Campbell, W.B.3
  • 45
    • 2342436795 scopus 로고    scopus 로고
    • Ethics and evidence based surgery
    • Stirrat GM. Ethics and evidence based surgery. J Med Ethics 2004; 30: 160-5.
    • (2004) J Med Ethics , vol.30 , pp. 160-165
    • Stirrat, G.M.1
  • 46
    • 0017826126 scopus 로고
    • The 'no lose' philosophy in medicine
    • Galbraith S. The 'no lose' philosophy in medicine. J Med Ethics 1978; 4: 61-3.
    • (1978) J Med Ethics , vol.4 , pp. 61-63
    • Galbraith, S.1
  • 47
    • 0037448393 scopus 로고    scopus 로고
    • Ensuring safe and effective medical devices
    • Feigal DW, Gardner SN, McClellan M. Ensuring safe and effective medical devices. N Engl J Med 2003; 348: 191-2. doi:10.1056/NEJMp020170.
    • (2003) N Engl J Med , vol.348 , pp. 191-192
    • Feigal, D.W.1    Gardner, S.N.2    McClellan, M.3
  • 48
    • 84857828102 scopus 로고    scopus 로고
    • Postmarketing surveillance of medical devices-fi lling in the gaps
    • Resnic FS, Normand SL. Postmarketing surveillance of medical devices-fi lling in the gaps. N Engl J Med. 2012; 366: 875-7. doi:10.1056/NEJMp1114865.
    • (2012) N Engl J Med , vol.366 , pp. 875-877
    • Resnic, F.S.1    Normand, S.L.2
  • 49
    • 0033951599 scopus 로고    scopus 로고
    • Introducing new technology: A stepwise algorithm
    • Malchau H. Introducing new technology: a stepwise algorithm. Spine (Phila Pa 1976) 2000; 25: 285.
    • (2000) Spine (Phila Pa 1976 , vol.25 , pp. 285
    • Malchau, H.1
  • 50
    • 20344382118 scopus 로고    scopus 로고
    • United states trends in lumbar fusion surgery for degenerative conditions
    • Deyo RA, Gray DT, Kreuter W, et al. United States trends in lumbar fusion surgery for degenerative conditions. Spine (Phila Pa 1976) 2005; 30: 1441-5.
    • (2005) Spine (Phila Pa 1976 , vol.30 , pp. 1441-1445
    • Deyo, R.A.1    Gray, D.T.2    Kreuter, W.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.