Bias in cervical total disc replacement trials

Radcliff, Kris; Siburn, Sean; Murphy, Hamadi; Woods, Barrett I.; Qureshi, Sheeraz A.

doi:10.1007/s12178-017-9399-2

Cited by 23 publications

(6 citation statements)

References 68 publications

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“…Mounting evidence supports cervical TDR (although not without conflict). 24 25 26 27 28 29 Lumbar TDR, on the other hand, is treated more cautiously: comparisons with standard fusion techniques by independent, non-industry-backed studies are few, pooled data are conflicting, 30 and long-term follow-up is scarce. 31…”

Section: Discussionmentioning

confidence: 99%

Clinical Practice in Spine Surgery: An International Survey

Pérez-Bovet

Buxó

Muñoz

2021

J Neurol Surg A Cent Eur Neurosurg

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Background The availability of diverse and sophisticated surgical options to treat spine conditions is compounded by the scarcity of high-level evidence to guide decision-making. Although studies on discrete treatments are frequently published, little information is available regarding real-world surgical practice. We intended to survey spine surgeons to assess clinical management of common spine diagnosis in day-to-day settings. Methods An online survey was distributed among neurosurgeons and orthopaedic surgeons worldwide. The obtained assessment of common surgical practice is contextualized in a review of the best available evidence. Results The survey was answered by more than 310 members of several European, Australasian, and South African professional societies. The submitted responses translate a surgical practice generally grounded on evidence, favoring well-tried techniques, providing comprehensive treatment for the most severe diagnoses. Such practice comes mostly from neurosurgeons focused on spine surgery, practicing in teaching hospitals. Conclusion We believe that the pragmatic, day-to-day approach to spine conditions captured in the present survey offers an informative insight to involved surgeons.

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Section: Discussionmentioning

confidence: 99%

Clinical Practice in Spine Surgery: An International Survey

Pérez-Bovet

Buxó

Muñoz

2021

J Neurol Surg A Cent Eur Neurosurg

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“…In a previously published RCT on cervical radiculopathy due to degenerative disk disease, 83 patients were operated with ADR (DiscoverTM, DePuy Spine, Johnson and Johnson, Raynham, Massachusetts, U.S.A.) at one or two levels [11,12]. The patients who had undergone revision surgery or Portions of this work were presented in podium presentation form at the CSRS 44th Annual Meeting, Toronto, Canada, December 1-3, 2016, at the CSRS 33th Annual Meeting, Salzburg, Austria, May [24][25][26]2017, and at the CSRS 47th Annual Meeting, New York, USA, November [21][22][23]2019.…”

Section: Methodsmentioning

confidence: 99%

“…The sponsors were not involved in the study design, conduct of the trial, data analysis, interpretation of the results or the writing of the manuscript. There is therefore a lesser risk for publication, external validity, confirmation or financial conflict of interest bias, the four sources of bias defined by Radcliff et al [24].…”

Section: Prevalence Of Homentioning

confidence: 99%

Unintended fusion in cervical artificial disk replacement: a prospective study on heterotopic ossification, progression, and clinical outcome, with 5-year follow-up

et al. 2021

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Purpose Heterotopic ossification (HO) may cause unintended fusion in artificial disk replacement (ADR), failing to preserve motion. The reported incidence of HO varies hugely. This study aimed to determine prevalence of HO, progression, predisposing factors to occurrence and to progression, and potential effect on clinical outcomes. Methods Eighty-three patients treated with ADRs for cervical radiculopathy at one or two segments were extracted from a previously published RCT. Of the 83 patients, 59 had remaining ADR (79 implants) and sufficiently high-quality X-rays at 5 years of follow-up to allow analysis. HO was graded on plain films according to Mehren/Suchomel. Prevalence, progression, predisposing factors and effect on clinical outcome (Neck Disability Index—NDI) were analyzed. Results At 2 years, HO was seen in 46/55 ADR implants (84%), severe enough to affect mobility in 27/55 (49%). At 5 years, HO was seen in 92% of 79 implants, severe in 71%. Male sex was a predisposing factor to HO. No predisposing factors to progression were identified. NDI was not affected by the severity of HO. Conclusion Almost all ADR implants in our study have HO at 5 years of follow-up. Male sex is a risk factor. Severe HO did not affect clinical outcome. Trial registration Study registered at ISRCTN (registration number: 44347115).

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“…[3] Several types of bias can be associated with industry-funded trials. Radcliff et al [46] identified four types of bias present in cervical arthroplasty trials: publication bias (tendency to publish studies with positive results), external validity (the extent to which the study results can be applied to situations outside of study conditions), confounding bias (a distortion that modifies an association between an exposure and an outcome because a factor is independently associated with the both), and financial conflicts of interest. Similar types of bias can be applied to other subspecialties of neurosurgical research funded by the industry.…”

Section: Trial Implementation Fundingmentioning

confidence: 99%

Randomized controlled trials in neurosurgery

Takroni

Sharma

Reddy

et al. 2022

Surgical Neurology International

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Randomized controlled trials (RCTs) have become the standard method of evaluating new interventions (whether medical or surgical), and the best evidence used to inform the development of new practice guidelines. When we review the history of medical versus surgical trials, surgical RCTs usually face more challenges and difficulties when conducted. These challenges can be in blinding, recruiting, funding, and even in certain ethical issues. Moreover, to add to the complexity, the field of neurosurgery has its own unique challenges when it comes to conducting an RCT. This paper aims to provide a comprehensive review of the history of neurosurgical RCTs, focusing on some of the most critical challenges and obstacles that face investigators. The main domains this review will address are: (1) Trial design: equipoise, blinding, sham surgery, expertise-based trials, reporting of outcomes, and pilot trials, (2) trial implementation: funding, recruitment, and retention, and (3) trial analysis: intention-to-treat versus as-treated and learning curve effect.

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Bias in cervical total disc replacement trials

Cited by 23 publications

References 68 publications

Clinical Practice in Spine Surgery: An International Survey

Clinical Practice in Spine Surgery: An International Survey

Unintended fusion in cervical artificial disk replacement: a prospective study on heterotopic ossification, progression, and clinical outcome, with 5-year follow-up

Randomized controlled trials in neurosurgery

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