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A prospective, randomised controlled trial of femoral ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2-year clinical results

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Abstract

The literature reports on the safety and efficacy of titanium cages (TCs) with additional posterior fixation for anterior lumbar interbody fusion. However, these papers are limited to prospective cohort studies. The introduction of TCs for spinal fusion has resulted in increased costs, without evidence of superiority over the established practice. There are currently no prospective controlled trials comparing TCs to femoral ring allografts (FRAs) for circumferential fusion in the literature. In this prospective, randomised controlled trial, our objective was to compare the clinical outcome following the use of FRA (current practice) to the use of TC in circumferential lumbar spinal fusion. Full ethical committee approval and institutional research and development departmental approval were obtained. Power calculations estimated a total of 80 patients (40 in each arm) would be required to detect clinically relevant differences in functional outcome. Eighty-three patients were recruited for the study fulfilling strict entry requirements (>6 months chronic discogenic low back pain, failure of conservative treatment, one- or two-level discographically proven discogenic low back pain). The patients completed the Oswestry Disability Index (ODI), Visual Analogue Score (VAS) for back and leg pain and the Short-Form 36 (SF-36) preoperatively and also postoperatively at 6, 12 and 24 months, respectively. The results were available for all the 83 patients with a mean follow-up of 28 months (range 24–75 months). Five patients were excluded on the basis of technical infringements (unable to insert TC in four patients and FRA in one patient due to the narrowing of the disc space). From the remaining 78 patients randomised, 37 received the FRA and 41 received the TC. Posterior stabilisation was achieved with translaminar or pedicle screws. Baseline demographic data (age, sex, smoking history, number of operated levels and preoperative outcome measures) showed no statistical difference between groups (p<0.05) other than for the vitality domain of the SF-36. For patients who received the FRA, mean VAS (back pain) improved by 2.0 points (p<0.01), mean ODI improved by 15 points (p=<0.01) and mean SF-36 scores improved by >11 points in all domains (p<0.03) except that of general health and emotional role. For patients who received the TC, mean VAS improved by 1.1 points (p=0.004), mean ODI improved by 6 points (p=0.01) and SF-36 improved significantly in only two of the eight domains (bodily pain and physical function). Revision procedures and complications were similar in both groups. In conclusion, this prospective, randomised controlled clinical trial shows the use of FRA in circumferential lumbar fusion to be associated with superior clinical outcomes when compared to those observed following the use of TCs. The use of TCs for circumferential lumbar spinal fusion is not justified on the basis of inferior clinical outcome and the tenfold increase in cost.

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References

  1. Andersen T, Christensen FB, Larsen M, Hoy K, Hansen ES, Bunger C (2001) Smoking as a predictor of negative outcome in lumbar spinal fusion. Spine 26:2623–2628

    Article  PubMed  Google Scholar 

  2. Burke JG, Watson RW, McCormack D, Dowling FE, Walsh MG, Fitzpatrick JM (2002) Intervertebral discs which cause low back pain secrete high levels of pro-inflammatory mediators. J Bone Joint Surg Br 84:196–201

    Article  PubMed  Google Scholar 

  3. Christensen FB, Hansen ES, Escaper SP, Hoy K, Helming P, Neumann P, Tiedemann B, Bunger CE (2002) Circumferential lumbar spinal fusion with Bartizan cage versus posterolateral fusion with titanium Cotrel-Dubousset instrumentation: a prospective, randomized clinical study of 146 patients. Spine 27:2674–2683

    Article  PubMed  Google Scholar 

  4. Christensen FB, Karlsmose B, Hansen ES, Bunger CE (1996) Radiological and functional outcome after anterior lumbar interbody spinal fusion. Eur Spine J 5:293–298

    Article  PubMed  Google Scholar 

  5. Cohen DB, Chotivichit A, Fujita T, Wong TH, Huckell CB, Sieber AN, Kostuik JP, Lawson HC (2000) Pseudarthrosis repair. Autogenous iliac crest versus femoral ring allograft. Clin Orthop Relat Res 371:46–55

    Google Scholar 

  6. Colhoun E, McCall IW, Williams L, Cassar PV (1988) Provocation discography as a guide to planning operations on the spine. J Bone Joint Surg Br 70:267–271

    PubMed  Google Scholar 

  7. Coppes MH, Marani E, Thomeer RT, Groen GJ (1997) Innervation of “painful” lumbar discs. Spine 22:2342–2349

    Article  PubMed  Google Scholar 

  8. Dennis S, Watkins R, Landaker S, Dillin W, Springer D (1989) Comparison of disc space heights after anterior lumbar interbody fusion. Spine 14:876–878

    PubMed  Google Scholar 

  9. Derby R, Howard MW, Grant JM, Lettice JJ, Van Peteghem PK, Ryan DP (1999) The ability of pressure-controlled discography to predict surgical and non-surgical outcomes. Spine 24:364–371

    PubMed  Google Scholar 

  10. Hagg O, Fritzell P, Nordwall A (2003) The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J 12:12–20

    PubMed  Google Scholar 

  11. Holte DC, O’Brien JP, Renton P (1994) Anterior lumbar fusion using a hybrid interbody graft. A preliminary radiographic report. Eur Spine J 3:32–38

    Google Scholar 

  12. Janssen ME, Lam C, Beckham R (2001) Outcomes of allogenic cages in anterior and posterior lumbar interbody fusion. Eur Spine J 10(Suppl 2):S158–S168

    Article  PubMed  Google Scholar 

  13. Kozak JA, O’Brien JP (1990) Simultaneous combined anterior and posterior fusion An independent analysis of a treatment for the disabled low-back pain patient. Spine 15:322–328

    PubMed  Google Scholar 

  14. Kulkarni SS, Lowery GL, Ross RE, Ravi SK, Lykomitros V (2003) Arterial complications following anterior lumbar interbody fusion: report of eight cases. Eur Spine J 12:48–54

    PubMed  Google Scholar 

  15. Kumar A, Kozak JA, Doherty BJ, Dickson JH (1993) Interspace distraction and graft subsidence after anterior lumbar fusion with femoral strut allograft. Spine 18:2393–2400

    PubMed  Google Scholar 

  16. Kumar N, Meakin JR, Kumar A, Mishra V, Mulholland RC (2005) Analysis of Stress in Lumbar interbody Fusion. Spine 30:1713–1735

    Google Scholar 

  17. Kumar N, Wild A, Webb JK, Aebi M (2000) Hybrid computer-guided and minimally open surgery: anterior lumbar interbody fusion and translaminar screw fixation. Eur Spine J 9(Suppl 1):S71–S77

    PubMed  Google Scholar 

  18. Lane JD, Moore ES (1948) Transperitoneal approach to the intervertebral disc in the lumbar area. Ann Surg 127:537

    Google Scholar 

  19. Liljenqvist U, O’Brien JP, Renton P (1998) Simultaneous combined anterior and posterior lumbar fusion with femoral cortical allograft. Eur Spine J 7:125–131

    Article  PubMed  Google Scholar 

  20. Linson MA, Williams H (1991) Anterior and combined anteroposterior fusion for lumbar disc pain. A preliminary study. Spine 16:143–145

    Google Scholar 

  21. Mayer HM (2003) Comment to “Arterial complications following anterior lumbar interbody fusion: report of eight cases”, by S.S. Kulkarni et al. Eur Spine J 12:55–56

    Google Scholar 

  22. McAfee PC (1999) Interbody fusion cages in reconstructive operations on the spine. J Bone Joint Surg Am 81:859–880

    PubMed  Google Scholar 

  23. McNally DS, Shackleford IM, Goodship AE, Mulholland RC (1996) In vivo stress measurement can predict pain on discography. Spine 21:2580–2587

    Article  PubMed  Google Scholar 

  24. Montesano PX, Magerl F, Jacobs RR, Jackson RP, Rauschning W (1988) Translaminar facet joint screws. Orthopedics 11:1393–1397

    PubMed  Google Scholar 

  25. Mulholland RC, Sengupta DK (2002) Rationale, principles and experimental evaluation of the concept of soft stabilization. Eur Spine J 11(Suppl 2):S198–S205

    PubMed  Google Scholar 

  26. O’Brien JP, Dawson MH, Heard CW, Momberger G, Speck G, Weatherly CR (1986) Simultaneous combined anterior and posterior fusion. A surgical solution for failed spinal surgery with a brief review of the first 150 patients. Clin Orthop Relat Res 203:191–195

    PubMed  Google Scholar 

  27. Patrick DL, Deyo RA, Atlas SJ, Singer DE, Chapin A, Keller RB (1995) Assessing health-related quality of life in patients with sciatica. Spine 20:1899–1908

    PubMed  Google Scholar 

  28. Pavlov PW, Meijers H, van Limbeek J, Jacobs WC, Lemmens JA, Obradov-Rajic M, de Kleuver M (2004) Good outcome and restoration of lordosis after anterior lumbar interbody fusion with additional posterior fixation. Spine 29:1893–1899

    Article  PubMed  Google Scholar 

  29. Phillips FM, Cunningham B, Carandang G, Ghanayem AJ, Voronov L, Havey RM, Patwardhan AG (2004) Effect of supplemental translaminar facet screw fixation on the stability of stand-alone anterior lumbar interbody fusion cages under physiologic compressive preloads. Spine 29:1731–1736

    Article  PubMed  Google Scholar 

  30. Polikeit A, Ferguson SJ, Nolte LP, Orr TE (2003) Factors influencing stresses in the lumbar spine after the insertion of intervertebral cages: finite element analysis. Eur Spine J 12:413–420

    Article  PubMed  Google Scholar 

  31. Rathonyi GC, Oxland TR, Gerich U, Grassmann S, Nolte LP (1998) The role of supplemental translaminar screws in anterior lumbar interbody fixation: a biomechanical study. Eur Spine J 7:400–407

    Article  PubMed  Google Scholar 

  32. Roberts S, Eisenstein SM, Menage J, Evans EH, Ashton IK (1995) Mechanoreceptors in intervertebral discs. Morphology, distribution, and neuropeptides. Spine 20:2645–2651

    Google Scholar 

  33. Sarwat AM, O’Brien JP, Renton P, Sutcliffe JC (2001) The use of allograft (and avoidance of autograft) in anterior lumbar interbody fusion: a critical analysis. Eur Spine J 10:237–241

    Article  PubMed  Google Scholar 

  34. Sasso RC, Kenneth BJ, LeHuec JC (2003) Retrograde ejaculation after anterior lumbar interbody fusion: transperitoneal versus retroperitoneal exposure. Spine 28:1023–1026

    Article  PubMed  Google Scholar 

  35. Sasso RC, Kitchel SH, Dawson EG (2004) A prospective, randomized controlled clinical trial of anterior lumbar interbody fusion using a titanium cylindrical threaded fusion device. Spine 29:113–122

    Article  PubMed  Google Scholar 

  36. Tiusanen H, Hurri H, Seitsalo S, Osterman K, Harju R (1996) Functional and clinical results after anterior interbody lumbar fusion. Eur Spine J 5:288–292

    Article  PubMed  Google Scholar 

  37. Tiusanen H, Seitsalo S, Osterman K, Soini J (1995) Retrograde ejaculation after anterior interbody lumbar fusion. Eur Spine J 4:339–342

    Google Scholar 

  38. Weiner BK Fraser RD (1998) Spine update lumbar interbody cages. Spine 23:634–640

    Article  PubMed  Google Scholar 

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Acknowledgements

We would like to thank Mr. James Hegarty and Mrs. Ellie Bevan-Davies for their assistance in data collection and database management.

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Correspondence to Brian J. C. Freeman.

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McKenna, P.J., Freeman, B.J., Mulholland, R.C. et al. A prospective, randomised controlled trial of femoral ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2-year clinical results. Eur Spine J 14, 727–737 (2005). https://doi.org/10.1007/s00586-005-1034-z

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  • DOI: https://doi.org/10.1007/s00586-005-1034-z

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