ArticleEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2020
Analysis of re-operations after cervical total disc replacement in a consecutive series of 535 patients receiving the ProDisc-C device.
Article 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, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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
5 citing papers in PubMed, 11 citations in OpenAlex.
- Treatment of failed cervical total disc replacements in a series of 53 cases and description of a management strategy.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
- No Difference in Two-Year Revisions Between Hybrid Fusion and Two-Level Anterior Discectomy and Fusion: A National Database Study.Global spine journal · 2024Article
- Revision Anterior Cervical Disc Arthroplasty: A National Analysis of the Associated Indications, Procedures, and Postoperative Outcomes.Global spine journal · 2022Article
- Anterior Cervical Foraminotomy for Radiculopathy After Cervical Artificial Disc Replacement: Technique Description and Case Report.International journal of spine surgery · 2022Article
- Hybrid Anterior Cervical Discectomy and Fusion and Cervical Disc Arthroplasty: An Analysis of Short-Term Complications, Reoperations, and Readmissions.Global spine journal · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionOne important factor in evaluating the safety of an implant is the rate of subsequent surgery and the reasons for surgery, particularly those that are related to possible problems with the implant. The purpose of this study was to determine the overall re-operation rate (including revisions, removals, device-related, procedure-related, adjacent segment, and others) for a large consecutive series of cervical TDR patients beginning with the first case experience, using a single device at a single institution.
methodsSurgery records were reviewed to identify cervical TDR patients and those who underwent subsequent surgery. Cervical TDR cases involving ProDisc-C were identified, beginning with the first case performed in 2003 at a multisite spine specialty centre. Only patients who were at least 2 years post-operative were included, producing a consecutive series of 535 patients. There were 115 hybrids in the series (TDR at one level and fusion at an adjacent segment). Data collected included general demographics and level(s) operated. A surgery log through 12-31-18 was reviewed to identify re-operations occurring in the TDR patients. For each re-operation, the reason, duration from index surgery, and procedure were recorded. The mean duration from the index surgery to the search of the surgery log for re-operations was 78.3 months, range 24 to 181 months.
resultsRe-operation occurred in 30 patients (5.6%). These included: 3 TDR removals and revision to anterior discectomy and fusion (1 for migration, 1 for subsidence, and 1 for spondylosis), 1 TDR repositioning, 21 secondary surgeries for adjacent segment degeneration (5 of which were adjacent to fusion levels in hybrid procedures), 1 wound infection, 1 hematoma, and 2 received stimulators for pain control. There were no re- operations for device failure. In cases of re-operation for adjacent segment degeneration, the mean duration between the index surgery and re-operation was 47.3 months.
conclusionThe re-operation rate was 5.6%. No surgeries were performed for device failure. These results support the safety of the TDR device.
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.