Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITÉ artificial disc versus lumbar fusion: Five-year follow-up

Guyer, Richard D.; McAfee, Paul C.; Banco, Robert; Bitan, Fabien D.; Cappuccino, Andrew; Geisler, Fred H.; Hochschuler, Stephen H.; Holt, Richard T.; Jenis, Louis G.; Majd, Mohamed E.; Regan, John J.; Tromanhauser, Scott; Wong, Douglas; Blumenthal, Scott L.

doi:10.1016/j.spinee.2008.08.007

Cited by 260 publications

(196 citation statements)

References 30 publications

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“…These reports were based upon five independent continuous clinical randomized control trials, reporting for different follow-up periods or containing separated results. Nine reports from the five RCTs with the relevant information are eventually included involving 837 patients [2,3,9,18,20,34,36,41,48].…”

Section: Description Of Studiesmentioning

confidence: 99%

A meta-analysis of artificial total disc replacement versus fusion for lumbar degenerative disc disease

Zhu

Han

et al. 2010

Eur Spine J

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Lumbar fusion has been developed for several decades and became the standard surgical treatment for symptomatic lumbar degenerative disc disease (DDD). Artificial total disc replacement (TDR), as an alternative for spinal arthrodesis, is becoming more commonly employed treating lumbar DDD. It is still uncertain whether TDR is more effective and safer than lumbar fusion. To systematically compare the effectiveness and safety of TDR to that of the fusion for the treatment of lumbar DDD, we performed a meta-analysis. Cochrane review methods were used to analyze all relevant randomized controlled trials published up to July 2009. Five relevant randomized controlled trials involving 837 patients were identified. Patients in TDR group have sightly better functioning and less back or leg pain without clinical significance, and significantly higher satisfaction status in TDR group compared with lumbar fusion group at the 2-year followup. But these outcomes are highly influenced by the study with BAK cage interbody fusion, the function/pain and patient satisfaction status are no longer significantly different between two groups after excluding this study. At 5 years, these outcomes are not significantly different between comparing groups. The complication and reoperation rate of two groups are similar both at 2 and at 5 years. In conclusion, TDR does not show significant superiority for the treatment of lumbar DDD compared with fusion. The benefits of motion preservation and the long-term complications are still unable to be concluded. More highquality RCTs with long-term follow-up are needed.

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Section: Description Of Studiesmentioning

confidence: 99%

A meta-analysis of artificial total disc replacement versus fusion for lumbar degenerative disc disease

Zhu

Han

et al. 2010

Eur Spine J

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“…Device failure included any reoperation required to modify or remove implants and any need for supplemental fixation. Major complications were defined as major vessel injury resulting in [1500 mL blood loss, neurological damage, or nerve root injury [9].…”

Section: Outcome Assessmentmentioning

confidence: 99%

“…Heterotopic ossification was evaluated using a 6-point scale adapted from McAfee et al [9,27]. The grades were defined as follows: 0, no evidence of HO; 1, HO present in islands of bone within soft tissue but not influencing segmental motion; 2, bone present within the disc space defined by the planes formed by the two adjacent end plates, but bony protrusions projecting more or less horizontally from the vertebral bodies; 3, bone present between the two planes without bridge; 4, apparent continuous connection of bridging bone between end plates; 5, indeterminate, for example, due to poor film quality.…”

Section: Outcome Assessmentmentioning

confidence: 99%

“…Several randomized [7][8][9][10][11][12] controlled trials have been carried out to compare TDR with lumbar fusion techniques and found no clinically relevant differences in pain or physical function, thus demonstrating that TDR produces at least equivalent clinical results compared with lumbar fusion. Prospective cohort studies of TDR also showed a significant reduction of pain intensity and improvement of functional impairment over short-to midterm follow-up [13][14][15][16][17].…”

Section: Introductionmentioning

confidence: 99%

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An 11-year minimum follow-up of the Charite III lumbar disc replacement for the treatment of symptomatic degenerative disc disease

Hai

Kong

et al. 2015

Eur Spine J

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Purpose To report our 11-year minimum clinical and radiological outcomes, as well as complications of the Charite III total disc replacement (TDR). Methods A total of 35 patients indicated for total disc replacement were implanted with the Charite III prosthesis. Clinical evaluation included visual analog scale (VAS) for back pain and the Oswestry disability index (ODI). Radiological parameters of intervertebral disc height (IDH), range of motion (ROM), lumbar lordosis, lumbar scoliosis and prosthesis position were evaluated. Complications and reoperation rates were also assessed. Results Thirty-two patients had a minimum 11-year follow-up, and 33 prostheses were implanted. The mean follow-up time was 11.8 years, ranging from 11.3 to 13.8 years. Twenty-eight patients (87.5 %) had a successful outcome, as defined by the FDA. Reoperation was performed in 2 patients for adjacent segment degeneration and pedicle fracture (1 case each). Both VAS and ODI scores showed significant improvement compared to baseline. At the final follow-up, the ROM of both the index-and adjacent-level showed an obvious decrease. The IDH of the index level showed a tendency to decrease, but the difference was not significant. The IDH of adjacent levels were not significantly affected by the surgery. Mean lumbar lordosis was increased at the final follow-up, and lumbar scoliosis over 3°was observed in 12 patients (37.5 %), with a mean angle of 5.6°(range 3°-12°). Of all 35 prostheses, 15 were left-shifted, 3 were right-shifted and 14 were just in the middle. In the coronal plane, 25 were rated as ideally placed, 5 were discretely shifted, 4 were slightly shifted and 1 was markedly shifted. In the sagittal plane, only 12 prostheses were rated as ideally placed, 14 were discretely shifted and 9 were suboptimally placed. Prosthesis subsidence was noted in 3 (9.4 %) patients (the subsidence distances were 3.1, 4.2 and 2.8 mm, respectively). Heterotopic ossification was detected in 25 segments (71.4 %), consisting of Class-I heterotopic ossification in 7 segments (20.0 %), Class-II in 9 segments (25.7 %), and Class-III in 9 segments (25.7 %). Class-IV heterotopic ossification was not observed. Conclusion The cumulative survival was 100 % at a mean follow-up of 11.8 years. Clinical and radiological results were satisfactory and long-term clinical results were maintained for a mean follow-up of 11.8 years. Reoperation and complication rates are acceptable, and our study does not substantiate the fear of reoperation or late complications. The results of our long-term follow-up indicate that, with strict indication, TDR is a safe and effective procedure as an alternative to lumbar fusion.

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“…Both of these options are associated with a success rate between 55 and 65%, as defined by improvement of or greater than 15 points on the Oswestry disability index [4]. These results have led clinicians to seek other technologies that would result in better outcomes and higher patient satisfaction.…”

Section: Introductionmentioning

confidence: 99%

The Fernstrom ball revisited

Siemionow

Lieberman

2011

Eur Spine J

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Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITÉ artificial disc versus lumbar fusion: Five-year follow-up

Cited by 260 publications

References 30 publications

A meta-analysis of artificial total disc replacement versus fusion for lumbar degenerative disc disease

A meta-analysis of artificial total disc replacement versus fusion for lumbar degenerative disc disease

An 11-year minimum follow-up of the Charite III lumbar disc replacement for the treatment of symptomatic degenerative disc disease

The Fernstrom ball revisited

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