Trial reportEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2016
A RCT comparing 7-year clinical outcomes of one level symptomatic cervical disc disease (SCDD) following ProDisc-C total disc arthroplasty (TDA) versus anterior cervical discectomy and fusion (ACDF).
Trial report in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
39 citing papers in PubMed, 8 syntheses or guidelines pooled it, 82 citations in OpenAlex.
- Outcomes of cervical arthroplasty versus anterior cervical arthrodesis: a systematic review and meta-analysis of randomized clinical trials with a minimum follow-up of 7-year.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2023Pooled it
- Cost-effectiveness of anterior surgical decompression surgery for cervical degenerative disk disease: a systematic review of economic evaluations.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2022Pooled it
- Cervical radiculopathy: is a prosthesis preferred over fusion surgery? A systematic review.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2020Pooled it
- Pooled it
- Long-term Results Comparing Cervical Disc Arthroplasty to Anterior Cervical Discectomy and Fusion: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Orthopaedic surgery · 2020Pooled it
- Cervical Artificial Disc Replacement Versus Fusion for Cervical Degenerative Disc Disease: A Health Technology Assessment.Ontario health technology assessment series · 2019Pooled it
- Secondary Surgery after Cervical Disc Arthroplasty versus Fusion for Cervical Degenerative Disc Disease: A Meta-analysis with Trial Sequential Analysis.Orthopaedic surgery · 2018Pooled it
- Multilevel cervical disc replacement versus multilevel anterior discectomy and fusion: A meta-analysis.Medicine · 2017Pooled it
- ProDisc-C versus anterior cervical discectomy and fusion for the surgical treatment of symptomatic cervical disc disease: two-year outcomes of Asian prospective randomized controlled multicentre study.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2022Trial
- Review
- Influence of the deviated center of rotation on facet joint degeneration after cervical disc replacement - an in vivo study with a minimum of 10-year follow-up.BMC surgery · 2024Article
- Could the different surgical goals of fusion and non-fusion also be achieved in combination within the same patient? Clinical and radiological outcome of hybrid cervical spine surgery.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2024Article
- Emerging Technologies within Spine Surgery.Life (Basel, Switzerland) · 2023Review
- A Systematic Review on Neurological Outcomes for Cervical Degenerative Myelopathy After Anterior Decompression Surgery: Motion Preservation vs Fusion.International journal of spine surgery · 2022Article
- [Comparison of short-term effectiveness of Prodisc-C Vivo artificial disc replacement and Zero-P fusion for treatment of single-segment cervical spondylosis].Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery · 2022Article
- Article
- Artificial intelligence in predicting early-onset adjacent segment degeneration following anterior cervical discectomy and fusion.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2022Article
- Anterior cervical discectomy and fusion without plate (ACDFWP) versus anterior cervical disc arthroplasty (ACDA) for cervical spondylosis: A meta-analysis and literature review.Intractable & rare diseases research · 2022Review
- Segmental Motion of Cervical Arthroplasty Leads to Decreased Adjacent-Level Degeneration: Analysis of the 7-Year Postoperative Results of a Multicenter Randomized Controlled Trial.International journal of spine surgery · 2022Article
- Comparison of Radiographic Reconstruction and Clinical Improvement between Artificial Cervical Disc Replacement and Anterior Cervical Discectomy and Fusion.Pain research & management · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe objective of this trial was to compare the safety and efficacy of TDA using the ProDisc-C implant to ACDF in patients with single-level SCDD between C3 and C7.
methodsWe report on the single-site results from a larger multicenter trial of 13 sites using an approved US Food and Drug Administration protocol (prospective, randomized controlled non-inferiority design). Patients were randomized one-to-one to either the ProDisc-C device or ACDF. All enrollees were evaluated pre- and post-operatively at regular intervals through month 84. Visual Analog Scale (VAS) for neck and arm pain/intensity, Neck Disability Index (NDI), Short-Form 36 (SF-36), and satisfaction were assessed.
resultsTwenty-two patients were randomized to each arm of the study. Nineteen additional patients received the ProDisc-C via continued access. NDI improved with the ProDisc-C more than with ACDF. Total range of motion was maintained with the ProDisc-C, but diminished with ACDF. Neck and arm pain improved more in the ProDisc-C than ACDF group. Patient satisfaction remained higher in the ProDisc-C group at 7 years. SF-36 scores were higher in the TDA group than ACDF group at 7 years; the difference was not clinically significant. Six additional operations (two at the same level; four at an adjacent level) were performed in the ACDF, but none in the ProDisc-C group.
conclusionsThe ProDisc-C implant appears to be safe and effective for the treatment of SCDD. Patients with the implant retained motion at the involved segment and had a lower reoperation rate than those with an ACDF.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.