Authors' objectives: To conduct a rapid review to evaluate the clinical effectiveness, safety and cost-effectiveness of cervical and lumbar total disc replacements versus conservative treatment and/or (discectomy and) fusion, respectively in subacute/chronic radicular arm pain and in chronic lumbar pain due to intervertebral disc disorder.

Authors' results and conclusions: Although some outcomes were statistically significant, none of the mean differences between cervical total disc replacement and cervical fusion for the main outcomes (quality of life, pain and functional status) were clinically relevant. Similar conclusions apply for the comparison between lumbar total disc replacement and lumbar fusion or conservative treatment. Revision surgery rate was slightly lower after cervical total disc replacement than after cervical fusion but the revision complexity was not taken into account. The results of the (low quality) economic evaluations were divergent, whatever the location of the total disc replacement. More large randomised controlled trials including a long follow-up are needed to study the clinical effectiveness and the safety. In the meantime, good quality economic evaluations cannot be performed. There is currently not sufficient evidence to advocate the reimbursement of any of the two artificial discs without strict conditions.

Authors' recommendations: CERVICAL TOTAL DISC REPLACEMENT To the Technical Medical Council and the Implants and Invasive Medical Devices Reimbursement Commission * From a clinical point of view, the cervical total disc replacement and the cervical fusion are roughly just as safe and effective in the short and medium term, while there is a lack of long-term data. Consequently, we recommend to keep the current reimbursement rules of the procedure, i.e. the reimbursement of the surgical procedure for cervical total disc replacement at the same tariff as the surgical procedure for cervical fusion, but under different nomenclature codes. There are currently not enough arguments yet to recommend a reimbursement of the cervical prosthesis without strict conditions. To the hospital responsibles and surgeons * In accordance with the law of 2002 relative to the patients’ rights, the patient should be clearly informed of the respective advantages and disadvantages as well as the cost of each surgical alternatives. Recommendations for further clinical research * Larger-scale RCTs, including a long-term follow-up (at least 10 years) are needed to conclude on the risk of adjacent segment degeneration and to confirm the slightly lower revision rate compared to cervical fusion and the higher complexity of reintervention in case of cervical total disc replacement. LUMBAR TOTAL DISC REPLACEMENT To the Technical Medical Council and the Implants and Invasive Medical Devices Reimbursement Commission * From a clinical point of view, the lumbar total disc replacement and the lumbar fusion are roughly just as safe and effective in the short and medium term, while there is a lack of long-term data. Consequently, we recommend to reimburse the surgical procedure for lumbar total disc replacement at the same tariff as the surgical procedure for lumbar fusion, but under different nomenclature codes. There are currently not enough arguments to recommend a reimbursement of the lumbar prosthesis without strict conditions. To the hospital responsibles and surgeons * In accordance with the law of 2002 relative to the patients’ rights, the patient should be clearly informed of the respective advantages and disadvantages as well as the cost of each surgical alternatives. Recommendations for further clinical research * Current and future RCTs should extend their follow-up period (at least 10 years) to study the long-term effectiveness and safety of each procedures.

Authors' methods: Systematic literature review of randomised controlled trials, systematic reviews and full economic evaluations in Medline, Embase, Cochrane and CRD (CDSR, DARE, HTA, NHS EED and CENTRAL). Analysis of national administrative databases and industry-launched survey results

Project Status: Completed

Year Published: 2015

URL for published report: https://doi.org/10.57598/R254C

URL for additional information: https://kce.fgov.be/en/publications/all-reports/cervical-and-lumbar-total-disc-replacements

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Belgium

DOI: 10.57598/R254C

Organisation Name: Belgian Health Care Knowledge Centre

Contact Address: Administrative Centre Botanique, Doorbuilding (10th floor), Boulevard du Jardin Botanique 55, B-1000 Brussels, Belgium tel: +32 2 287 33 88 fax: +32 2 287 33 85

Contact Name: info@kce.fgov.be

Contact Email: info@kce.fgov.be

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