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Project Summary

<div class="ck-content" data-wrapper="true" dir="ltr" style="--ck-image-style-spacing: 1.5em; --ck-inline-image-style-spacing: calc(var(--ck-image-style-spacing) / 2); font-family: 'Segoe UI','Helvetica Neue',sans-serif; font-size: 9pt;"><p style="margin: 0; margin-left: 0cm; margin-right: 0cm;"><span style="color:black;font-family:&quot;Calibri&quot;,sans-serif;font-size:12pt;">Open tibial (lower leg) fractures are complex injuries requiring surgical fixation. An antibiotic coated nail called the ETN PROtect, manufactured by DePuy Synthes (Johnson &amp; Johnson), is designed to reduce infection risk by releasing local antibiotics. However, this implant is not approved by the USA FDA due to safety concerns about its gentamicin-based coating, including cytotoxicity and ototoxicity.</span></p><p style="margin: 0; margin-left: 0cm; margin-right: 0cm;">&nbsp;</p><p style="margin: 0; margin-left: 0cm; margin-right: 0cm;"><span style="color:black;font-family:&quot;Calibri&quot;,sans-serif;font-size:12pt;">At the Royal London Hospital, a Major Trauma Centre, we have used the ETN PROtect in over 130 cases. This service evaluation uses routinely collected surgical and outcome data to compare patients who received ETN PROtect versus the standard uncoated ETN. The findings will improve local surgical decision making.&nbsp;</span></p></div>

Detailed Project Description

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div class="page" style="-webkit-text-stroke-width:0px; caret-color:#000000; color:#000000; font-style:normal; font-variant-caps:normal; font-weight:400; letter-spacing:normal; orphans:auto; text-align:start; text-decoration:none; text-indent:0px; text-transform:none; white-space:normal; widows:auto; word-spacing:0px" title="Page 1"><div class="section" style="background-color:#ffffff"><div class="layoutArea"><div class="column"><p><span style="font-family:Helvetica; font-size:10pt">Open tibial fractures represent a major clinical and economic burden. They occur at an incidence of approximately 17 per 100,000 person-years and account for a significant proportion of long bone injuries treated in trauma centres [1]. Due to the high energy mechanisms often involved, these injuries are frequently associated with soft tissue compromise, contamination, and high rates of infection and delayed union.</span></p><p><span style="font-family:Helvetica; font-size:10pt">Standard care involves intramedullary nailing, which has been associated with good mechanical stability and reduced soft tissue disruption. However, deep infection remains a serious complication, particularly in Gustilo-Anderson grade IIIB and IIIC injuries, where rates have been reported as high as 30% despite appropriate debridement and systemic antibiotic use [2,3].</span></p><p><span style="font-family:Helvetica; font-size:10pt">The ETN Protect system incorporates a gentamicin coating to the standard ETN nail. Gentamicin is released locally during the early post-operative period, aiming&nbsp;to reduce early bacterial colonisation and infection risk. While the implant is CE- marked and used widely in Europe, it has not received FDA approval due to concerns of systemic toxicity from antibiotic elution, with in-vitro studies raising concerns about potential ototoxic and nephrotoxic effects [4,5].</span></p><div class="page" style="-webkit-text-stroke-width:0px; caret-color:#000000; color:#000000; font-style:normal; font-variant-caps:normal; font-weight:400; letter-spacing:normal; orphans:auto; text-align:start; text-decoration:none; text-indent:0px; text-transform:none; white-space:normal; widows:auto; word-spacing:0px" title="Page 2"><div class="section" style="background-color:#ffffff"><div class="layoutArea"><div class="column"><p><span style="font-family:Helvetica; font-size:10pt">Clinical studies from European centres, including those from Germany and the UK, suggest that coated nails may reduce infection in open fractures without increasing systemic toxicity [6,7]. However, high-quality comparative data are limited. A 2022 single-centre study by Patel et al. at the Royal London provided preliminary findings supporting lower rates of infection in ETN Protect recipients, but lacked comparator cohorts and had a limited sample size [8].</span></p><p><span style="font-family:Helvetica; font-size:10pt">Given the scale of use at Royal London—over 130 ETN Protect implants within a cohort of approximately 530 total tibial nails—this service evaluation presents a unique opportunity to examine short-, medium- and long-term clinical outcomes. It may use data mapped to the Observational Medical Outcomes Partnership (OMOP) common data model and analysed within the OHDSI network’s tools as well as a manual notes review. This service evaluation will advise the local service as well as the manufacturers of real-world evidence and our local union rate whne using this nail. Our evaluation is not generalisable.</span></p></div></div></div></div></div></div></div></div></div>

Requested Data Summary

<div data-wrapper="true"><div class="page" style="text-align:start; text-indent:0px" title="Page 2"><div class="section" style="background-color:#ffffff"><div class="layoutArea"><div class="column"><p><span style="font-family:Helvetica; font-size:small">From an existing Trust database: Cerner notes review as well as Xrays held on PACS</span><br><br><span style="font-family:Helvetica; font-size:small">Demographic&nbsp;data, clinical outcomes, operative notes review, re-operation rates, complications rates, and radiological union rates.&nbsp;</span></p></div></div></div></div></div>

Technical Description

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div>Analysis will be done manually using R once data has been collected into an Excel sheet which had been uploaded and approved by the CEU.&nbsp;</div><div>We do not aim to use any open source software.&nbsp;</div><div>&nbsp;</div><div>Inclusion:</div><div><div class="page" style="-webkit-text-stroke-width:0px; caret-color:#000000; color:#000000; font-style:normal; font-variant-caps:normal; font-weight:400; letter-spacing:normal; orphans:auto; text-align:start; text-decoration:none; text-indent:0px; text-transform:none; white-space:normal; widows:auto; word-spacing:0px" title="Page 2"><div class="section" style="background-color:#ffffff"><div class="layoutArea"><div class="column"><p><span style="font-family:Helvetica; font-size:10pt">•Age =18 years<br>•Diagnosis: Tibial shaft fracture (ICD-10: S82.20, S82.21, S82.2X) •Procedure: Intramedullary nailing (OPCS-4: W19.1, W19.2, W44.1) •Available implant logs confirming use of ETN Protect or uncoated ETN •At least 12 months of follow-up data available, where union is the primary outcome</span></p><p><span style="font-family:Helvetica; font-size:10pt">Exclusion:</span></p><p>&nbsp;</p><div class="page" style="-webkit-text-stroke-width:0px; caret-color:#000000; color:#000000; font-style:normal; font-variant-caps:normal; font-weight:400; letter-spacing:normal; orphans:auto; text-align:start; text-decoration:none; text-indent:0px; text-transform:none; white-space:normal; widows:auto; word-spacing:0px" title="Page 3"><div class="section" style="background-color:#ffffff"><div class="layoutArea"><div class="column"><p><span style="font-family:Helvetica; font-size:10pt">•Missing implant identification<br>•Transferred patients with incomplete follow-up •Pathological fractures (e.g., metastatic disease)</span></p></div></div></div></div><p>Sample Size:</p><p>&nbsp;</p><div class="page" style="-webkit-text-stroke-width:0px; caret-color:#000000; color:#000000; font-style:normal; font-variant-caps:normal; font-weight:400; letter-spacing:normal; orphans:auto; text-align:start; text-decoration:none; text-indent:0px; text-transform:none; white-space:normal; widows:auto; word-spacing:0px" title="Page 2"><div class="section" style="background-color:#ffffff"><div class="layoutArea"><div class="column"><p><span style="font-family:Helvetica; font-size:10pt">All patients in the Cerner database - implant has been in use for over 7 years at this site.</span></p><p>&nbsp;</p><p>&nbsp;</p></div></div></div></div></div></div></div></div></div><div>&nbsp;</div></div>

Public and Patient Involvement and Engagement Summary

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt">This study has not been reviewed by a PPI group.&nbsp;</div>

Reporting

<div class="ck-content" data-wrapper="true" dir="ltr" style="--ck-image-style-spacing: 1.5em; --ck-inline-image-style-spacing: calc(var(--ck-image-style-spacing) / 2); font-family: 'Segoe UI','Helvetica Neue',sans-serif; font-size: 9pt;"><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif;font-size:9pt;">We aim to publish a paper with our local service evaluation.&nbsp;</div></div>

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Abernethy Building E1 2AT

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