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

Abstract

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.

Retrospective Study on Effectiveness of Activ L Total Disc Replacement

“…Postfusion pain is independent of factors such as poor posture, paraspinal muscle pain, or pseudoarthrosis, and showed a signi cant correlation with sagittal imbalance such as decreased ST, increased pelvic tilt and decreased LL. [17] Our previous study on better treatment options in patients with DDD has led us to the discovery of a more preferable option of motion-preserving total disc arthroplasty [6,7] , avoiding fusion. But to our knowledge, the effect of TDR with Activ L on sagittal alignment has not been studied till date.…”

“…Siepeet al [5] have prospectively analyzed the clinical e cacy of TDR with ProDisc II (DePuySynthes Inc., West Chester, PA, USA), and the results revealed satisfactory and maintained mid-to long-term clinical outcomes after a mean follow-up of 7.4 years. The midterm results of TDR with SB Charité III (DePuySynthes Inc.) prosthesis [6] and clinical results of 1-to 3-year follow-up with activ L arti cial disc (Aesculap AG & Co. KG, Tuttlingen, Germany) [7] have been reported previously, and revealed satisfactory clinical outcomes in both patient cohorts. However, a ve-year, prospective, randomized multicenter study showed no signi cant differences in the clinical outcomes between TDR and fusion.…”

Operative Management of Lumbar Degenerative Disc Disease

“…There is no current conclusive evidence of LDA superiority in the long-term in level I studies and the surgery is technically more challenging. However, mid-term studies of LDA have reported satisfactory clinical results and implant survival and comparable complication profiles to fusion [9394] with proponents of LDA supporting its use for several theoretical and clinical advantages.…”

“…Complication rates, while reported to be lower than fusion in the Charité trials (29.1% for arthroplasty and 50.2% for fusion at 2-year follow-up), are still significant [113]. These can be broadly separated into those related to the anterior surgical approach (e.g., vascular injury, nerve root injury, retrograde ejaculation), prosthesis/fusion failure (e.g., subsidence, osteolysis, migration, implant fracture, endplate fracture, pseudoarthrosis), heterotopic ossification (up to 76% at 3 years) and subsequent hypomobility of the implant and donorsite complications [93]. Device failures necessitating repeat operations have been reported at 5.4% to 6.3%.…”

Long-term clinical outcome of two revision strategies for failed total disc replacements

“…However, TDR may have serious drawbacks [10][11][12], such as subsidence, facet joint degeneration, dislocation or malposition of the implant, requiring surgical revision [13][14][15][16]. According to the literature, 6-14% of patients needed revision fusion surgery after TDR [10,11,[17][18][19].…”