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On Total Disc Replacement
Linköping University, Department of Clinical and Experimental Medicine, Orthopaedics and Sports Medicine . Linköping University, Faculty of Health Sciences.
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.
Series
Linköping University Medical Dissertations, ISSN 0345-0082 ; 1168
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:liu:diva-54290ISBN: 978-91-7393-439-8 (print)OAI: oai:DiVA.org:liu-54290DiVA: diva2:302558
Public defence
2010-03-26, Aulan, Psykiatribyggnaden, Löwenströmska Sjukhuset, Upplands Väsby, 13:00 (English)
Opponent
Supervisors
Available from: 2010-03-08 Created: 2010-03-08 Last updated: 2010-05-10Bibliographically approved
List of papers
1. Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up
Open this publication in new window or tab >>Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up
Show others...
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.

Keyword
Degenerative disc disease, Prospective randomised controlled trial, Total disc replacement, Spinal fusion, Patients global assessment of back pain
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-51285 (URN)10.1007/s00586-009-1047-0 (DOI)
Available from: 2009-10-26 Created: 2009-10-26 Last updated: 2010-03-08
2. Sex life and sexual function in men and women before and after total disc replacement compared with posterior lumbar fusion
Open this publication in new window or tab >>Sex life and sexual function in men and women before and after total disc replacement compared with posterior lumbar fusion
2009 (English)In: The spine journal, ISSN 1529-9430, E-ISSN 1878-1632, Vol. 9, no 12, 987-994 p.Article in journal (Refereed) Published
Abstract [en]

BACKGROUND CONTEXT: Sex life and sexual function maybe affected by low back pain (LBP). Sexual dysfunction after anterior lumbar fusion is reported in both men and women, but focus is mainly on impaired male biological function (retrograde ejaculation) as this may cause infertility. This has led to concern as to whether anterior surgery should be employed in men, at least in younger age groups. PURPOSE: To investigate how chronic low back pain (CLBP) of assumed discogenic origin affects sex life and sexual function in patients considered for surgical treatment, whether this is affected by surgical treatment (total disc replacement [TDR] or posterolateral fusion [PLF]/posterior lumbar interbody fusion [PLIF]), and if so, are there differences between the surgical procedures undertaken. STUDY DESIGN: A randomized controlled trial comparing TDR and instrumented lumbar spine fusion, performed either as a PLF or PLIF. PATIENT SAMPLE: One hundred fifty-two patients were included in this randomized controlled trial to compare the effect on CLBP of either TDR via an anterior retroperitoneal approach or instrumented posterior lumbar fusion, PLF or PLIF. OUTCOME MEASURES: Global assessment of back pain, back pain (visual analog scale [VAS] 0-100), function (Oswestry Disability Index [ODI] 0-100), quality of life (EQ5D [EuroQol] 0-1), and answers on specific sexual function. METHODS: Outcome was assessed using data from the Swedish Spine Register (SweSpine). In ODI, one question, ODI 8, reflects the impact of back pain on sex life. This question was analyzed separately. Patients also answered a gender-specific questionnaire preoperatively and at the 2-year follow-up to determine any sexual dysfunction regarding erection, orgasm, and ejaculation. Followup was at 1 and 2 years. RESULTS: Before surgery, 34% reported that their sex life caused some extra LBP, and an additional 30% that their sex life was severely restricted by LBP. After surgery, sex life improved in both groups, with a strong correlation to a reduction of LBP. The gender-specific questionnaire used to measure sexual function after 2 years revealed no negative effect of TDR or Fusion in men regarding erection or retrograde ejaculation. However, 26% of all men in the Fusion group, compared with 3% in the TDR group, reported postoperative deterioration in the ability to achieve orgasm, despite a reduction of LBP CONCLUSIONS: Impairment of sex life appears to be related to CLBP. An improvement in sex life after TDR or lumbar fusion was positively correlated to a reduction in LBP. Total disc replacement in this study, performed through an anterior retroperitoneal approach, was not associated with greater sexual dysfunction compared with instrumented lumbar fusion performed either as a PLF or as a PLIF. Sexual function, expressed as orgasm, deteriorated in men in the Fusion group postoperatively, in spite of this group reporting less LBP after 2 years.

Keyword
Sex life; Sexual dysfunction; Retrograde ejaculation; Total disc replacement; Lumbar fusion; Low back pain
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-52885 (URN)10.1016/j.spinee.2009.08.454 (DOI)
Available from: 2010-01-13 Created: 2010-01-12 Last updated: 2017-12-12
3. Disc height and motion patterns in the lumbar spine in patients treated with total disc replacement or fusion for discogenic back pain: Results from a randomized controlled trial
Open this publication in new window or tab >>Disc height and motion patterns in the lumbar spine in patients treated with total disc replacement or fusion for discogenic back pain: Results from a randomized controlled trial
2011 (English)In: The spine journal, ISSN 1529-9430, E-ISSN 1878-1632, Vol. 11, no 11, 991-998 p.Article in journal (Refereed) Published
Abstract [en]

Study Design. Comparison of X-ray measurements in a randomized controlled trial between instrumented posterior fusion (N=72) and total disc replacement (TDR) (N=80) for chronic low back pain assumed to be discogenic. Results were compared to clinical outcome.

Objective. To see if surgical goals for respective treatments had been reached, if clinical outcome was related to this, and if differences in disc height and adjacent segment motion patterns between groups occurred.

Summary of Background Data. Fusion is considered the “gold standard” in surgical treatment of degenerated disc disease, though the resulting stiffness may induce degeneration in adjacent segments. TDR aims to restore and maintain mobility by replacing a painful disc. Little is known about the degree and quality of mobility in artificial discs in vivo, and whether maintained mobility reduces stress on adjacent segments.

Methods. Flexion-extension X-rays were analyzed pre- and two years postoperatively using Distortion Compensated Roentgen Analysis (DCRA) at treated and adjacent levels, mobility following fusion and TDR was estimated. Changes in disc height and changes in mobility patterns in adjacent segments were compared. The results were compared with clinical outcome regarding back pain.

Results. 78% of fused patients had no mobility whereas 89% of TDR-patients were mobile, but with less than normal mobility. The fulfilment of surgical goals was not correlated to clinical outcome. Fused segments were lower and TDR-segments were higher than normal. There were minor differences, there being more translation or flexion-extension at adjacent levels in the fusion group than in the TDR group.

Conclusions. This very accurate X-ray method (DCRA) indicates that surgical goals were reached in most patients. This however, was not correlated to outcome. Differences between the groups in postoperative disc height and motion patterns at adjacent segments may lead to differences in outcome in the long-term perspective, but this was not detectable after two years.

Place, publisher, year, edition, pages
Elsevier, 2011
Keyword
RCT, Fusion, total disc replacement, mobility, disc height, clinical outcome, DCRA, adjacent segment
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-54288 (URN)10.1016/j.spinee.2011.08.434 (DOI)000297864300001 ()
Available from: 2010-03-08 Created: 2010-03-08 Last updated: 2017-12-12
4. Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-year follow-up:  
Open this publication in new window or tab >>Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-year follow-up:  
Show others...
2011 (English)In: European spine journal, ISSN 0940-6719, E-ISSN 1432-0932, Vol. 20, no 7, 1001-1011 p.Article in journal (Refereed) Published
Abstract [en]

When low back pain becomes chronic, surgery is sometimes performed. The gold standard today is lumbar fusion (FUS), using a variety of procedures. Total disc replacement (TDR) aimed at motion preservation is increasing in popularity. This randomized controlled health economic study assesses the cost-effectiveness of TDR (Charité/Prodisc/Maverick) compared with instrumented FUS (posterior lumbar fusion (PLF)/posterior lumbar interbody fusion (PLIF). Social and healthcare perspectives after two years are reported. In all, 152 patients were randomized to either TDR (n=80) or FUS (n=72). Cost to society, (total mean cost/patient, Swedish kronor=SEK, standard deviation) for TDR was SEK 599,560 (400,272), and for FUS SEK 685,919 (422,903) (ns). TDR was significantly less costly from a healthcare perspective, SEK 22,996 (43,055- -1,202). Number of days on sick leave among those who returned to work was 185 (146) in the TDR group, and 252 (189) in the FUS group (ns). Using EQ-5D, the total gain in quality adjusted life years (QALYs) over two years was 0.41 units for TDR and 0.40 units for FUS (ns). Based on EQ-5D, the incremental cost effectiveness ratio (ICER) of using TDR instead of FUS was difficult to analyze due to the “non-difference” in treatment outcome, which is why cost/QALY could not be defined. Using cost-effectiveness probabilistic analysis, the net benefit with CI) was found to be SEK 91,359 (-73,643 – 249,114) (ns).

Conclusion: It is not possible to state whether TDR or FUS is more cost-effective after two years. Since disc replacement and lumbar fusion are based on different conceptual approaches, it is important to follow these results over time.

Place, publisher, year, edition, pages
Springer, 2011
Keyword
Disc prosthesis; Lumbar fusion; Cost-effectiveness; Cost-utility; Health economic evaluation
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:liu:diva-54289 (URN)10.1007/s00586-010-1607-3 (DOI)000292746500002 ()
Available from: 2010-03-08 Created: 2010-03-08 Last updated: 2017-12-12

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