A Systematic Review to Summarise and Appraise the Reporting of Surgical Innovation: a Case Study in Robotic Roux-en-Y Gastric Bypass.

Robotic Roux-en-Y gastric bypass (RRYGB) is an innovative alternative to traditional laparoscopic approaches. Literature has been published investigating its safety/efficacy; however, the quality of reporting is uncertain. This systematic review used the Idea, Development, Exploration, Assessment and Long-term follow-up (IDEAL) framework to assess the reporting quality of available literature. A narrative summary was formulated, assessing how comprehensively governance/ethics, patient selection, demographics, surgeon expertise/training, technique description and outcomes were reported. Forty-seven studies published between 2005 and 2024 were included. There was incomplete/inconsistent reporting of governance/ethics, patient selection, surgeon expertise/training and technique description, with heterogenous outcome reporting. RRYGB reporting was poor and did not align with IDEAL guidance. Robust prospective studies reporting findings using IDEAL/other guidance are required to facilitate safe widespread adoption of RRYGB and other surgical innovations.

Caring for patients with periprosthetic femoral fractures across England and Wales in 2021.

Aims: The aim of this study was to describe services available to patients with periprosthetic femoral fracture (PPFF) in England and Wales, with focus on variation between centres and areas for care improvement. Methods: This work used data freely available from the National Hip Fracture Database (NHFD) facilities survey in 2021, which asked 21 questions about the care of patients with PPFFs, and nine relating to clinical decision-making around a hypothetical case. Results: Of 174 centres contributing data to the NHFD, 161 provided full responses and 139 submitted data on PPFF. Lack of resources was cited as the main reason for not submitting data. Surgeon (44.6%) and theatre (29.7%) availability were reported as the primary reasons for surgical delay beyond 36 hours. Less than half had a formal process for a specialist surgeon to operate on PPFF at least every other day. The median number of specialist surgeons at each centre was four (interquartile range (IQR) 3 to 6) for PPFF around both hips and knees. Around one-third of centres reported having one dedicated theatre list per week. The routine discussion of patients with PPFF at local and regional multidisciplinary team meetings was lower than that for all-cause revision arthroplasties. Six centres reported transferring all patients with PPFF around a hip joint to another centre for surgery, and this was an occasional practice for a further 34. The management of the hypothetical clinical scenario was varied, with 75 centres proposing ORIF, 35 suggested revision surgery and 48 proposed a combination of both revision and fixation. Conclusion: There is considerable variation in both the organization of PPFF services England and Wales, and in the approach taken to an individual case. The rising incidence of PPFF and complexity of these patients highlight the need for pathway development. The adoption of networks may reduce variability and improve outcomes for patients with PPFF.

A systematic review of robot-assisted anti-reflux surgery to examine reporting standards.

Robot-assisted anti-reflux surgery (RA-ARS) is increasingly being used to treat refractory gastro-oesophageal reflux disease. The IDEAL (Idea, Development, Exploration, Assessment, Long-term follow up) Collaboration's framework aims to improve the evaluation of surgical innovation, but the extent to which the evolution of RA-ARS has followed this model is unclear. This study aims to evaluate the standard to which RA-ARS has been reported during its evolution, in relation to the IDEAL framework. A systematic review from inception to June 2020 was undertaken to identify all primary English language studies pertaining to RA-ARS. Studies of paraoesophageal or giant hernias were excluded. Data extraction was informed by IDEAL guidelines and summarised by narrative synthesis. Twenty-three studies were included: two case reports, five case series, ten cohort studies and six randomised controlled trials. The majority were single-centre studies comparing RA-ARS and laparoscopic Nissen fundoplication. Eleven (48%) studies reported patient selection criteria, with high variability between studies. Few studies reported conflicts of interest (30%), funding arrangements (26%), or surgeons' prior robotic experience (13%). Outcome reporting was heterogeneous; 157 distinct outcomes were identified. No single outcome was reported in all studies.The under-reporting of important aspects of study design and high degree of outcome heterogeneity impedes the ability to draw meaningful conclusions from the body of evidence. There is a need for further well-designed prospective studies and randomised trials, alongside agreement about outcome selection, measurement and reporting for future RA-ARS studies.

A systematic review of robot-assisted cholecystectomy to examine the quality of reporting in relation to the IDEAL recommendations: systematic review.

INTRODUCTION: Robotic cholecystectomy (RC) is a recent innovation in minimally invasive gallbladder surgery. The IDEAL (idea, development, exploration, assessment, long-term study) framework aims to provide a safe method for evaluating innovative procedures. This study aimed to understand how RC was introduced, in accordance with IDEAL guidelines. METHODS: Systematic searches were used to identify studies reporting RC. Eligible studies were classified according to IDEAL stage and data were collected on general study characteristics, patient selection, governance procedures, surgeon/centre expertise, and outcome reporting. RESULTS: Of 1425 abstracts screened, 90 studies were included (5 case reports, 38 case series, 44 non-randomized comparative studies, and 3 randomized clinical trials). Sixty-four were single-centre and 15 were prospective. No authors described their work in the context of IDEAL. One study was classified as IDEAL stage 1, 43 as IDEAL 2a, 43 as IDEAL 2b, and three as IDEAL 3. Sixty-four and 51 provided inclusion and exclusion criteria respectively. Ethical approval was reported in 51 and conflicts of interest in 34. Only 21 reported provision of training for surgeons in RC. A total of 864 outcomes were reported; 198 were used in only one study. Only 30 reported a follow-up interval which, in 13, was 1 month or less. CONCLUSION: The IDEAL framework was not followed during the adoption of RC. Few studies were conducted within a research setting, many were retrospective, and outcomes were heterogeneous. There is a need to implement appropriate tools to facilitate the incremental evaluation and reporting of surgical innovation.

Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty.

BACKGROUND: In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to understand device use and outcomes since this implant entered clinical practice in order to establish incremental evidence, appropriate study design and reporting. This systematic review summarised and appraised studies reporting pyrocarbon proximal interphalangeal joint arthroplasty. METHODS: Systematic review of MEDLINE, EMBASE, SCOPUS, Web of Science, BIOSIS, CINAHL and CENTRAL from inception to November 2020. All study designs reporting pyrocarbon proximal interphalangeal joint arthroplasty in humans were included. Data extracted included information about study characteristics, patient selection, regulatory (gaining research ethics approval) and governance issues (reporting of conflicting interests), operator and centre experience, technique description and outcome reporting. Descriptive and narrative summaries were reported. RESULTS: From 4316 abstracts, 210 full-text articles were screened. A total of 38 studies and 1434 (1-184) patients were included. These consisted of three case reports, 24 case series, 10 retrospective cohort studies and one randomised trial. Inclusion and exclusion criteria were stated in 25 (66%) studies. Most studies (n = 27, 71%) gained research ethics approval to be conducted. Six studies reported conflicting interests. Experience of operating surgeons was reported in nine (24%) and caseload volume in five studies. There was no consensus about the optimal surgical approach. Technical aspects of implant placement were reported frequently (n = 32) but the detail provided varied widely. Studies reported multiple, heterogenous outcomes. The most commonly reported outcome was range of motion (n = 37). CONCLUSIONS: This systematic review identified inconsistencies in how studies describing the early use and update of an innovative procedure were reported. Incremental evidence was lacking, risking the implant being adopted without robust evaluation. This review adds to evidence highlighting the need for more rigorous evaluation of how implantable medical devices are used in practice following licencing.

The association between surgical fixation of hip fractures within 24 hours and mortality : a systematic review and meta-analysis.

AIMS: The aim of this study was to assess the effect of time to surgical intervention from admission on mortality and morbidity for patients with hip fractures. METHODS: MEDLINE and Embase were searched from inception to June 2020. Reference lists were manually assessed to identify additional papers. Primary comparative research studies that recruited patients aged over 60 years, with non-pathological primary proximal femoral fractures that were treated surgically, were included. Studies that did not include a group operated on within 24 hours or which reported time to surgery in calendar days were excluded. Two investigators extracted data on study characteristics, methods, and outcomes. The pre-defined primary outcome was 30-day mortality. Secondary outcomes were complications and mortality at other time points. Relative risks (RRs) with 95% confidence intervals (CIs) were aggregated and were grouped by study-level characteristics. RESULTS: This review included 46 studies (January 1991 to June 2020), comprising 521,857 hip fractures with 64,047 postoperative deaths. No randomized controlled trials were eligible for inclusion. In a pooled analysis of 15 studies, RR of mortality at 30 days comparing time to surgery < 24 hours with > 24 hours was 0.86 (95% CI 0.82 to 0.91; I 2 = 69%; 95% CI 50% to 81%; p-value for heterogeneity < 0.001). The association was stronger in observational studies that did not adjust for confounders than in those that adjusted for multiple covariates. In a pooled analysis of six studies, the RR of mortality at 30 days comparing time to surgery < 24 hours with 24 to 36 hours was 0.87 (95% CI 0.81 to 0.93; I 2 = 65%; 95% CI 16% to 85%; p-value for heterogeneity = 0.014). CONCLUSION: This meta-analysis indicates reduced mortality for patients operated within 24 hours compared with those operated on beyond 24 hours or within 24 to 36 hours. Where resources allow and there is no specific reversible contraindication to early surgery, we recommend that hip fractures should be surgically treated within 24 hours. Cite this article: Bone Joint J 2021;103-B(7):1176-1186.

Magnet Fracture within a Magnetically Controlled Growing Rod: A Case Report of a New Mechanism of Failure.

INTRODUCTION: Magnetically controlled growing rods (MCGRs) have been widely adopted in the management of early-onset scoliosis since they were first described in 2012. Recent reports have highlighted concerns around their safety. To date, little is understood about the risk factors and modes of failure in these devices. CASE REPORT: We report a novel mechanism of device failure in a 14-year-old patient following multiple revisions of MCGRs.Clinically, there was no evidence of device failure and the MCGRs appeared radiologically intact. Explantation analysis revealed multiple compromised/non-functional components. A previously undocumented phenomenon of complete magnet fracture was also seen. CONCLUSION: The absence of clinical or radiological features of device failure in this case makes the findings of great concern. Given the relative paucity of high-quality evidence surrounding the use of MCGRs, we support calls for urgent comparative studies and further investigation of risk factors for device failure.

Incomplete cauda equina syndrome secondary to haemorrhage within a Tarlov cyst.

Sacral perineural (Tarlov) cysts are benign, cerebrospinal fluid containing lesions of the spinal nerve root sheath. They are usually asymptomatic; however, a small proportion have the potential to cause compression of nerve roots and/or the cauda equina.We report a case of a 61-year-old man who presented with acute onset back pain associated with bilateral radiculopathy. Between referral and consultation, the patient developed urinary dysfunction which resolved spontaneously.MRI revealed haemorrhage within a Tarlov cyst, resulting in compression of the cauda equina. Due to the considerable clinical improvement at the time of consultation, surgical decompression of the cyst was not considered to be indicated.An interval MRI scan 8 weeks later demonstrated that the haemorrhage within the perineural cyst had spontaneously resolved and the patient remained asymptomatic at 5-year follow-up.

The current state of the evidence for the use of drains in spinal surgery: systematic review.

PURPOSE: Search for evidence pertaining to the effectiveness of drains used in spinal surgeries. METHOD: PubMed and EMBASE databases were searched for articles pertaining to the use of drains in all types of spinal surgery. The bibliographies of relevant studies were searched for additional papers that met the initial inclusion criteria. Level I and II studies were scored according to guidelines in the Cochrane Collaboration Back Review Group. We utilised the Population, Intervention, Comparison, Outcomes and Study design (PICOS) method to define our study eligibility criteria. RESULTS: Nineteen papers were identified: four level I studies, eight level III studies and seven level IV studies. The four level I, involving the randomization of patients into 'drain' and 'non-drain' groups, identified a total of 363 patients. Seven of the eight level III retrospective studies concluded that the use of drains did not reduce complications. Two of the seven level IV studies agreed with this conclusion. The remaining five level IV studies reported the benefits of lumbar drainage following dural tears. CONCLUSIONS: There is a paucity of published literature on the use of drains following spinal surgery. This is the first study to assess the evidence for the benefits of drains post-operatively in spinal surgery. The identified studies have shown that drains do not reduce the incidence of complications in anterior cervical discectomy and fusion, one and two level posterior cervical fusions, lumbar laminectomies, lumbar decompressions or discectomies and posterior spinal fusion for adolescent scoliosis. Further level I and II studies are needed.

Actuator pin fracture in magnetically controlled growing rods: two cases.

BACKGROUND CONTEXT: Magnetically controlled growing rods (MCGRs) are used in the management of early-onset scoliosis (EOS). Each MCGR contains a telescopic actuator that serves as the distraction element when stimulated by an external remote controller (ERC), permitting non-invasive lengthening in the outpatient clinic. PURPOSE: This report highlights a subtle cause of MCGR failure. We present the first two reported cases of lengthening pin fracture in patients with dual-MCGR constructs. STUDY DESIGN: We present two cases of patients with EOS treated with dual-construct MAGEC (MAGnetic Expansion Control, Ellipse Technologies Inc, Aliso Viejo, CA, USA) MCGRs. METHODS: A 12-year-old boy presented describing a "popping" sensation in his thoracic spine and resultant grating 36 months following MCGR insertion. RESULTS: A plain radiograph revealed a subtle fracture of the lengthening pin within the actuator of the right MCGR. Following identification of this case of implant failure, we reviewed the most recent radiographs of all nine of our patients treated with this MCGR in our institution, resulting in the discovery of bilateral MCGR lengthening pin fractures in an otherwise asymptomatic 11-year-old girl. CONCLUSIONS: Clinicians should have a high index of suspicion of structural implant failure when presented with histories similar to those reported in our first case, or following unsuccessful distraction of MCGRs. In such cases new radiographs should be taken, and all previous images should be reviewed for evidence of this phenomenon. Centers that document MCGR lengthening with ultrasound should obtain plain radiographs every 6 months to evaluate the structural integrity of the implant.