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Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up
Lowenstromska Hospital.
Lowenstromska Hospital.
Lowenstromska Hospital.
Lowenstromska Hospital.
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2009 (English)In: EUROPEAN SPINE JOURNAL, ISSN 0940-6719, Vol. 18, no 10, 1512-1519 p.Article in journal (Refereed) Published
Abstract [en]

The study design includes a prospective, randomised controlled study comparing total disc replacement (TDR) with posterior fusion. The main objective of this study is to compare TDR with lumbar spinal fusion, in terms of clinical outcome, in patients referred to a spine clinic for surgical evaluation. Fusion is effective for treating chronic low back pain (LBP), but has drawbacks, such as stiffness and possibly adjacent level degradation. Motion-preserving options have emerged, of which TDR is frequently used because of these drawbacks. How the results of TDR compare to fusion, however, is uncertain. One hundred and fifty-two patients with a mean age of 40 years (21-55) were included: 90 were women, and 80 underwent TDR. The patients had not responded to a conservative treatment programme and suffered from predominantly LBP, with varying degrees of leg pain. Diagnosis was based on clinical examination, radiographs, MRI, and in unclear cases, diagnostic injections. Outcome measures were global assessment (GA), VAS for back and leg pain, Oswestry Disability Index, SF36 and EQ5D at 1 and 2 years. Follow-up rate was 100%, at both 1 and 2 years. All outcome variables improved in both groups between preoperative and follow-up assessment. The primary outcome measure, GA, revealed that 30% in the TDR group and 15% in the fusion group were totally pain-free at 2 years (P = 0.031). TDR patients had reached maximum recovery in virtually all variables at 1 year, with significant differences compared to the fusion group. The fusion patients continued to improve and at 2 years had results similar to TDR patients apart from numbers of pain-free. Complications and reoperations were similar in both groups, but pedicle screw removal as additive surgery, was frequent in the fusion group. One year after surgery, TDR was superior to spinal fusion in clinical outcome, but this difference had diminished by 2 years, apart from (VAS for back pain and) numbers of pain-free. The long-term benefits have yet to be examined.

Place, publisher, year, edition, pages
2009. Vol. 18, no 10, 1512-1519 p.
Keyword [en]
Degenerative disc disease, Prospective randomised controlled trial, Total disc replacement, Spinal fusion, Patients global assessment of back pain
National Category
Medical and Health Sciences
URN: urn:nbn:se:liu:diva-51285DOI: 10.1007/s00586-009-1047-0OAI: diva2:273941
Available from: 2009-10-26 Created: 2009-10-26 Last updated: 2010-03-08
In thesis
1. On Total Disc Replacement
Open this publication in new window or tab >>On Total Disc Replacement
2010 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Low back pain consumes a large part of the community’s resources dedicated to health care and sick leave. Back disorders also negatively affect the individual leading to pain suffering, decreased quality-of-life and disability. Chronic low back pain (CLBP) due to degenerative disc disease (DDD) is today often treated with fusion when conservative treatment has failed and symptoms are severe. This treatment is as successful as arthroplasty is for hip arthritis in restoring the patient’s quality of life and reducing disability. Even so, there are some problems with this treatment, one of these being recurrent CLBP from an adjacent segment (ASD) after primarily successful surgery. This has led to the development of alternative surgical treatments and devices that maintain or restore mobility, in order to reduce the risk for ASD. Of these new devices, the most frequently used are the disc prostheses used in Total Disc Replacement (TDR).

This thesis is based on four studies comparing total disc replacement with posterior fusion. The studies are all based on a material of 152 patients with DDD in one or two segments, aged 20-55 years that were randomly treated with either posterior fusion or TDR.

The first study concerned clinical outcome and complications. Follow-up was 100% at both one and two years. It revealed that both treatment groups had a clear benefit from treatment and that patients with TDR were better in almost all outcome scores at one-year follow-up. Fusion patients continued to improve during the second year. At two-year follow-up there was a remaining difference in favour of TDR for back pain. 73% in the TDR group and 63% in the fusion group were much better or totally pain-free (n.s.), while twice as many patients in the TDR group were totally pain free (30%) compared to the fusion group (15%).

Time of surgery and total time in hospital were shorter in the TDR group.

There was no difference in complications and reoperations, except that seventeen of the patients in the fusion group were re-operated for removal of their implants.

The second study concerned sex life and sexual function. TDR is performed via an anterior approach, an approach that has been used for a long time for various procedures on the lumbar spine. A frequent complication reported in males when this approach is used is persistent retrograde ejaculation. The TDR group in this material was operated via an extra-peritoneal approach to the retroperitoneal space, and there were no cases of persistent retrograde ejaculation. There was a surprisingly high frequency of men in the fusion group reporting deterioration in ability to have an orgasm postoperatively.

Preoperative sex life was severely hampered in the majority of patients in the entire material, but sex life underwent a marked improvement in both treatment groups by the two-year follow-up that correlated with reduction in back pain.

The third study was on mobility in the lumbar spinal segments, where X-rays were taken in full extension and flexion prior to surgery and at two-year follow-up. Analysis of the films showed that 78% of the patients in the fusion group reached the surgical goal (non-mobility) and that 89% of the TDR patients maintained mobility.

Preoperative disc height was lower than in a normative database in both groups, and remained lower in the fusion group, while it became higher in the TDR group. Mobility in the operated segment increased in the TDR group postoperatively. Mobility at the rest of the lumbar spine increased in both treatment groups. Mobility in adjacent segments was within the norm postoperatively, but slightly larger in the fusion group.

In the fourth study the health economics of TDR vs Fusion was analysed. The hospital costs for the procedure were higher for patients in the fusion group compared to the TDR group, and the TDR patients were on sick-leave two months less.

In all, these studies showed that the results in the TDR group were as good as in the fusion group. Patients are more likely to be totally pain-free when treated with TDR compared to fusion. Treatment with this new procedure seems justified in selected patients at least in the short-term perspective. Long-term follow-up is underway and results will be published in due course.

Place, publisher, year, edition, pages
Linköping: Linköping University Electronic Press, 2010. 70 p.
Linköping University Medical Dissertations, ISSN 0345-0082 ; 1168
National Category
Medical and Health Sciences
urn:nbn:se:liu:diva-54290 (URN)978-91-7393-439-8 (ISBN)
Public defence
2010-03-26, Aulan, Psykiatribyggnaden, Löwenströmska Sjukhuset, Upplands Väsby, 13:00 (English)
Available from: 2010-03-08 Created: 2010-03-08 Last updated: 2010-05-10Bibliographically approved

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Tropp, Hans
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Orthopaedics and Sports Medicine Faculty of Health SciencesDepartment of Orthopaedics Linköping
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