Prosthetic intervertebral disc replacement

PICHON-RIVIERE A,; AUGUSTOVSKI, F; ALCARAZ A; BARDACH, ARIEL; GARCIA MARTÍ, SEBASTIAN; LOPEZ, A; GLUJOVSKY, D; REGUEIRO, A

Documentos de Evaluación de Tecnologías Sanitarias

IECS

Año: 2006 p. 1 - 30

1668-2793

The purpose of this report is to assess the usefulness of intervertebral disc replacement for spine degenerative diseases.A search was carried out on the main literature databases (MEDLINE, Cochrane Collaboration, DARE, LILACS, NHS NICE, EMBASE) Centre for Reviews and Dissemination, York University (CRD), on the Internet's general search engines, health technology assessment agencies and health sponsors. Priority was given to systematic and narrative reviews and randomized clinical trials. Series of cases were also included.In 2003, De Kleuver et al conducted a systematic review. They evaluated 9 case series with a total of 564 artificial discs (Charit and Acroflex). The authors concluded that the procedure has a high rate of reoperations, that it should be considered as an experimental procedure and that, at present, data are not enough to adequately assess performance of disc replacement. However, these series are before 2000. In 2003, Zigler et al report a RCT with Prodisc II (28 patients) versus lumbar spine fusion in the control arm (11 patients), with a 6-month follow-up. Hospital stay was shorter in the Prodisc arm. After 6 months, there were no statistically significant differences in pain scales. Guyer et al. (2004), compare the Charit disc with the BAK arthrodesis technology in a RCT with 144 patients and a 24-month follow-up. Results were evaluated according to the Oswestry Disability Index and were similar for both methods.In a multicenter RCT, Blumenthal et al (2005) compared the Charit disc (n=205) with intervertebral fusion with fusion cages (n=99). There were no significant differences in rate of complications for both groups. According to the authors, clinical success was achieved in 57.1% of patients in the Charite group and 46.5% in the surgical control group (p<0.001). The RCT considered presents several methodological problems, including, among others, the loss to follow-up of a group of patients, which make result interpretation difficult. Case series with longer follow-ups (Tropiano, Lemaire) report results which are similar to the preceding ones.As regards experience with the Bryant cervical disc, the quality of the evidence is even poorer. Most common complications (3-50%) were pain progression, spine infection, vascular and presacral plexus damage. Also, other transient or temporary neurological complications are reported.Coverage policyIn October, 2004, the U.S FDA approved the use of the Charit artificial disc. In Canada, the use of the Bryant cervical disc has also been licensed. The U.S BlueCross BlueShield, ICSI and CIGNA do not cover this indication. AETNA covers it in highly selected patients.The cost of the prosthesis ranges between $20,000 and $25,000 (Argentine pesos, 2006) depending on the trademark.