Dataset Information

A pilot, masked, randomized controlled trial to evaluate local gentamicin versus saline in open tibial fractures (pGO-Tibia).

ABSTRACT:

Background

Open tibial fractures have a high risk of infection that can lead to severe morbidity. Antibiotics administered locally at the site of the open wound are a potentially effective preventive measure, but there are limited data evaluating aminoglycoside antibiotics. The objective of this study was to assess the feasibility of a clinical trial to test the efficacy of local gentamicin in reducing the risk of fracture-related infection after open tibial fracture.

Methods

This study is a single-center, pilot, masked, randomized controlled trial conducted at the Muhimbili Orthopaedic Institute. Participants were randomized intraoperatively after wound closure to receive gentamicin solution or normal saline solution injected at the fracture site. Follow-ups were completed at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 1 year postoperatively. The primary feasibility outcomes were the rate of enrollment and retention. The primary clinical outcome was the occurrence of fracture-related infection.

Results

Of 199 patients screened, 100 eligible patients were successfully enrolled and randomized over 9 months (11.1 patients/month). Complete data were recorded at baseline and follow-up for >95% of cases. The rate of follow-up at 6 weeks, 3 months, 6 months, 9 months, and 1 year were 70%, 68%, 69%, 61%, and 80%, respectively. There was no difference in adverse events or any of the measured primary and secondary outcomes.

Conclusion

This pilot study is among the first to evaluate locally administered gentamicin in open tibial fractures. Results indicate a rigorous clinical trial with acceptable rates of enrollment and follow-up to address this topic is possible in this setting.

SUBMITTER: Haonga BT

PROVIDER: S-EPMC10503693 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

A pilot, masked, randomized controlled trial to evaluate local gentamicin versus saline in open tibial fractures (pGO-Tibia).

Haonga Billy T BT Ngunyale Patrick P von Kaeppler Ericka P EP Donnelley Claire A CA Won Nae Y NY Eliezer Edmund N EN Brown Kelsey K Flores Michael M O'Marr Jamieson M JM Rodarte Patricia P Urva Mayur M Cortez Abigail A Porco Travis T Morshed Saam S Shearer David W DW

OTA international : the open access journal of orthopaedic trauma 20230327 2

<h4>Background</h4>Open tibial fractures have a high risk of infection that can lead to severe morbidity. Antibiotics administered locally at the site of the open wound are a potentially effective preventive measure, but there are limited data evaluating aminoglycoside antibiotics. The objective of this study was to assess the feasibility of a clinical trial to test the efficacy of local gentamicin in reducing the risk of fracture-related infection after open tibial fracture.<h4>Methods</h4>This ...[more]

PMID: 37719315

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Project description:The role of low-intensity pulsed ultrasound (LIPUS) in the management of fractures remains controversial. The purpose of this study was to assess the feasibility of a definitive trial to determine the effect of LIPUS on functional and clinical outcomes in tibial fractures managed operatively.We conducted a multicenter, concealed, blinded randomized trial of 51 skeletally mature adults with operatively managed tibial fractures who were treated with either LIPUS or a sham device. All participating centers were located in Canada and site investigators were orthopedic surgeons specializing in trauma surgery. The goals of our pilot study were to determine recruitment rates in individual centers, investigators' ability to adhere to study protocol and data collection procedures, our ability to achieve close to 100% follow-up rates, and the degree to which patients were compliant with treatment. Patients were followed for one year and a committee (blinded to allocation) adjudicated all outcomes. The committee adjudicators were experienced (10 or more years in practice) orthopedic surgeons with formal research training, specializing in trauma surgery.Our overall rate of recruitment was approximately 0.8 patients per center per month and site investigators successfully adhered to the study protocol and procedures. Our rate of follow-up at one year was 84%. Patient compliance, measured by an internal timer in the study devices, revealed that 39 (76%) of the patients were fully compliant and 12 (24%) demonstrated a greater than 50% compliance. Based on patient feedback regarding excessive questionnaire burden, we conducted an analysis using data from another tibial fracture trial that revealed the Short Musculoskeletal Function Assessment (SMFA) dysfunction index offered no important advantages over the SF-36 Physical Component Summary (PCS) score. No device-related adverse events were reported.Our pilot study identified key issues that might have rendered a definitive trial unfeasible. By modifying our protocol to address these challenges we have enhanced the feasibility of a definitive trial to explore the effect of LIPUS on tibial fracture healing.The TRUST definitive trial was registered at ClinicalTrials.gov on 21 April 2008 (identifier: NCT00667849).

Project description:PurposeThe purpose of this study was to reveal the treatment preferences and current practices regarding open tibial shaft fracture (OTSF).Patients and methodsOnline surveys of treatment preferences and current practice of OTSF were conducted by orthopedic trauma doctors from various medical institutions in Zhejiang Province. The survey contains three modules. The first module is the basic information of the participants, the second module is the treatment patterns for Gustilo-Anderson type I-II (GA I/II), and the third module is the treatment patterns for Gustilo-Anderson type IIIA (GA IIIA). Furthermore, each treatment pattern was divided into four aspects, including antibiotic prophylaxis, irrigation and debridement, fracture stabilization, and wound management.ResultsA total of 132 orthopedic trauma doctors from 41 hospitals in Zhejiang province, participated the online surveys. In GA I-IIIA OTSF, more than three-quarters of participants considered <3 h as the appropriate timing of antibiotic administration after trauma. In fact, only 41.67% of participants administered antibiotics within 3 h after trauma. 90.91 and 86.36% of participants thought debridement within 6 h was reasonable for GA I/II and GA IIIA OTSF, respectively. However, in reality only about half of patients received debridement within 6 h on average. The most common reason for delayed debridement was patients' transport delay. 87.88 and 97.3% of participants preferred secondary internal fixation following external fixation for GA I/II and GA IIIA OTSF, respectively. Additionally, over half of participants preferred use of locking plate for treating GA I-IIIA OTSF. The most common reasons for choosing delayed internal fixation for GA I-IIIA OTSF were infection risk and damage control. 78.79 and 65.91% supported immediate internal fixation after removing the external fixation for GA I-IIIA OTSF, respectively. Regarding wound closure, 86.36 and 63.64% of participants reported primary closure for GA I/II and GA IIIA OTSF, respectively. Over three fourths of participants agreed that preoperative and postoperative multiple wound cultures should be performed to predict infection for GA I-IIIA OTSF.ConclusionThe study first presents the current preference and practice regarding management of GA I-IIIA OTSF in Zhejiang. Majority of surgeons in our study preferred secondary internal fixation following external fixation for GA I-IIIA OTSF and over half of surgeons preferred use of locking plate for treating GA I-IIIA OTSF. This study may provide a reference for trauma orthopedic surgeons in the treatment of GA I-IIIA OTSF.

Project description:PurposeTo examine the condition and triggers of stress fractures of the lateral tibial plateau (LTP) similar to type III lateral hinge fractures (LHFs) after open wedge high tibial osteotomy (OWHTO).MethodsOWHTO was performed in 118 knees. They were examined for LHFs by computed tomography (CT). Patients were divided into the stress fracture group (Group SF) if they showed fracture lines on CT performed after starting weight-bearing walking and the normal group (Group N) for others.ResultsThe mean age was significantly older in Group SF (P = 0.022). Preoperatively, Group SF showed a significantly higher tibio-femoral angle (TFA, P = 0.014). No significant differences were observed in TFA and weight-bearing line ratio after surgery. Correction angle was significantly higher in the SF group. And all of the SF were more than 13 degrees. There was no significant difference in LHF incidence between groups, whereas stress fracture incidence differed significantly for each type of LHF (chi-squared test, P = 0.0001): 14.6% of type I cases, 100% of type II cases, 0% of type III cases, and 6.1% of those without LHF.DiscussionThe load on the LTP is assumed to act as a shearing force in type II fractures, which may contribute greatly to stress fractures. In type III, stress fractures may not occur because of the load dispersed at the fracture part. The stress fracture site is similar to type III LHF, and this kind of fracture is thought to be a delayed type III because it occurs after patients start weight-bearing walking. Moreover, they are observed in type I cases with a stable hinge and in 6% of cases without LHF. This study showed that high varus knees corrected with a large correction angle may develop stress fractures. OWHTO requires attention to stress fractures of the LTP, which can be regarded as delayed type III, in those developing LHFs postoperatively or having a high varus knee preoperatively.ConclusionThese results indicated the possibility of stress fracture in LTP during weight-bearing exercise after OWHTO, which was regarded as a delayed type III fracture. The results showed that Correction angle was more than 13 degrees, and lateral hinge fracture type II of the Takeuchi classification was an inducement of this stress fracture.Level of evidenceLevel IV.

Project description:BackgroundInfection remains a costly, devastating complication following the treatment of open fractures. The appropriate timing of debridement is controversial, and available evidence has been conflicting.MethodsThis study is a retrospective analysis of the SIGN (Surgical Implant Generation Network) Surgical Database (SSDB), a prospective registry of fracture cases in predominantly low-resource settings. Skeletally mature patients (≥16 years of age) who returned for follow-up at any time point after intramedullary nailing of an open femoral or tibial fracture were included. Patients were excluded if they had delays in debridement exceeding 7 days after the injury. Utilizing a model adjusting for potential confounders, including patient demographic characteristics, injury characteristics, country income level, and hospital type and resources, local logistic regression analysis was performed to evaluate the probability of infection with increasing time to debridement in 6-hour increments.ResultsIn this study, 27.3% of patients met the eligibility criteria and returned for follow-up, with a total of 10,651 fractures from 61 countries included. Overall, the probability of infection increased by 0.17% for every 6-hour delay in debridement. On subgroup analysis, the probability of infection increased by 0.23% every 6 hours for Gustilo-Anderson type-III injuries compared with 0.13% for Gustilo-Anderson type-I or II injuries. The infection risk increased every 6 hours by 0.18% for tibial fractures compared with 0.13% for femoral fractures.ConclusionsThere was a linear and cumulative increased risk of infection with delays in debridement for open femoral and tibial fractures. Such injuries should be debrided promptly and expeditiously. The size and international nature of this cohort make these findings uniquely generalizable to nearly all environments where such injuries are treated.Level of evidenceTherapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

Dataset Information

A pilot, masked, randomized controlled trial to evaluate local gentamicin versus saline in open tibial fractures (pGO-Tibia).

Background

Methods

Results

Conclusion

Publications

A pilot, masked, randomized controlled trial to evaluate local gentamicin versus saline in open tibial fractures (pGO-Tibia).

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