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Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 102 - 102
1 Dec 2022
Bhattacharjee S Seidel H Liu A Liu C Strelzow J
Full Access

The use of cannabis is increasingly medically relevant as it is legalized and gains acceptance more broadly. However, the effects of marijuana use on postoperative outcomes following orthopedic surgery have not been well-characterized. This study seeks to illuminate the relationship between marijuana use and the incidence postoperative complications including: DVT, PE, nonunion, and infection following common orthopedic procedures. This study was conducted using a national orthopaedic claims insurance database. We identified all patients undergoing knee arthroscopy, shoulder arthroscopy, operatively managed long bone fractures (humerus, femur, tibia and/or fibula, and radius and/or ulna), and single-level lumbar fusion. The proportion of patients within each surgery cohort who had a diagnostic code for marijuana dependence was assessed. The rates of DVT, PE, and infection within 90 days were assessed for all patients. The rate of nonunion was assessed for the long bone fracture and lumbar fusion cohorts. Univariate analyses of marijuana dependence on all outcomes were performed, followed by a multivariate logistic regression analysis controlling for known patient comorbidities. We identified 1,113,944 knee arthroscopy, 747,938 shoulder arthroscopy, 88,891 lumbar fusion, and 37,163 long bone fracture patients. Out of the 1,987,936 patients, 24,404 patients had a diagnostic code for marijuana dependence. Within all four surgical subgroups, the marijuana dependence cohort experienced increased rates of infection, PE, and DVT, as well as increased rates of nonunion in the lumbar fusion and long bone fracture populations. In the multivariate analyses controlling for a variety of patient risk factors including tobacco use, marijuana dependence was identified as an independent risk factor for infection within all four surgical subgroups (Knee: OR 1.85, p < 0.001; Shoulder: OR 1.65, p < 0.001; Spine: OR 1.45, p < 0.001; Long bone: OR 1.28, p < 0.001), and for nonunion in the lumbar fusion (OR 1.38, p < 0.001) and long bone fracture (OR 1.31, p < 0.001) subgroups. Our data suggests that marijuana dependence may be associated with increased rates of infection and nonunion following a variety of orthopaedic procedures. During preoperative evaluation, surgeons may consider marijuana use as a potential risk factor for postoperative complications, especially within the context of marijuana legalization. Future research into this relationship is necessary


Bone & Joint Research
Vol. 8, Issue 6 | Pages 255 - 265
1 Jun 2019
Hernigou J Schuind F

Objectives. The aim of this study was to review the impact of smoking tobacco on the musculoskeletal system, and on bone fractures in particular. Methods. English-language publications of human and animal studies categorizing subjects into smokers and nonsmokers were sourced from MEDLINE, The Cochrane Library, and SCOPUS. This review specifically focused on the risk, surgical treatment, and prevention of fracture complications in smokers. Results. Smokers have an increased risk of fracture and experience more complications with delayed bone healing, even if they have already stopped smoking, because some adverse effects persist for a prolonged period. Some risks can be reduced during and after surgery by local and general prevention, and smoking cessation is an important factor in lessening this risk. However, if a patient wants to stop smoking at the time of a fracture, the cessation strategies in reducing tobacco use are not easy to implement. The patient should also be warned that using e-cigarettes or other tobaccos does not appear to reduce adverse effects on health. Conclusion. The evidence reviewed in this study shows that smoking has a negative effect in terms of the risk and treatment of fractures. Cite this article: J. Hernigou, F. Schuind. Tobacco and bone fractures: A review of the facts and issues that every orthopaedic surgeon should know. Bone Joint Res 2019;8:255–265. DOI: 10.1302/2046-3758.86.BJR-2018-0344.R1


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_2 | Pages 94 - 94
1 Mar 2021
Harrison A
Full Access

Abstract. Objectives. Review the evidence of low intensity pulsed ultrasound (LIPUS) for fracture non-union treatment and the potential to treat fractures in patients with co-morbidities at risk of fracture non-union. Methods. Data was gathered from both animal and human studies of fracture repair to provide an overview of the LIPUS in bone healing applications to provide in-depth evidence to substantiate the use in treatment of non-union fractures and to propose a scientific rational to develop a clinical development programme. Results. LIPUS is an effective method for treating fracture non-union, with most studies showing heal rates in the mid 80%. In the UK NICE has published MTG-12 guidance for non-union treatment, which demonstrates that LIPUS is an effective and cost effective method as an alternative to surgery to treat non-union fractures. Basic science studies and evaluation of clinical trial data has led to the understanding that LIPUS can mitigate co-morbidities related to failure of bone healing such as diabetes, advancing age and tobacco use. Future clinical trials will evaluate the use of LIPUS in acute fractures in patients with high risk of low bone healing capacity to prevent the development of a non-union. As with all medical treatments, LIPUS for fracture repair needs to be used appropriately, with poorly fixed fractures or large fracture gaps, being unsuitable for LIPUS treatment. In addition, considerations such as targeting the fracture site in deep-seated bones and clinician / patient engagement to ensure good compliant usage are vital factors to ensure good clinical outcomes. Conclusion. Using basic science research, a thorough knowledge of the mechanism of action has been established, which has elucidated that co-morbidities related to the development of fracture non-union can be mitigated by the LIPUS technology. A pragmatic clinical trial in the United States is currently ongoing to test these hypothesises clinically. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_14 | Pages 72 - 72
1 Dec 2019
Yeung C Lichstein P Varady N Bonner B Carrier C Schwab P Maguire J Chen A Estok D
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Aim. Knee arthrodesis (KA) and above knee amputation (AKA) have been used for salvage of failed total knee arthroplasty (TKA) in the setting of periprosthetic joint infection (PJI). The factors that lead to a failed fusion and progression to AKA are not well understood. The purpose of our study was to determine factors associated with failure of a staged fusion for PJI and predictive of progression to AKA. Method. We retrospectively reviewed a single-surgeon series of failed TKA for PJI treated with two-stage KA between 2000 and 2016 with minimum 2-year follow-up. Patient demographics, comorbidities, surgical history, tissue compromise, and radiographic data were recorded. Outcomes were additional surgery, delayed union, Visual Analog Pain scale (VAS) and Western Ontario and McMaster Activity score (WOMAC). No power analysis was performed for this retrospective study. Medians are reported as data were not normally distributed. Results. Fifty-one knees underwent fusion with median follow-up of 7 years (interquartile range (IQR) of 2–18 years). Median age was 71 years old (IQR 47 – 98), with a M:F ratio of 23:28. Median BMI was 34.3 kg/m2 (IQR 17.9–61). Infection was eradicated in 47 knees (92.2%); 24 knees (47.0%) required no additional surgery. 41 patients (83.6%) remained ambulatory after knee fusion, with 21% of these patients (10 total) requiring no ambulatory assistive device. Median VAS following arthrodesis was 4.6 (range 0–10). Median WOMAC was 36.2 (range 9–86). Three TKAs (5.9%) underwent AKA for overwhelming infection. Predictors of AKA were chronic kidney disease (OR 4.0, 95% CI 0.6–26.8), peripheral vascular disease (OR 3.5, 95% CI 0.3–44.7), AORI III bone loss (OR 2.6, 95% CI 0.4–35.2), instability (OR 2.2, 95% CI 0.2–15.9), and immunosuppression (OR 1.1, 95% CI 0.1–7.8). Tobacco use (OR 8.6, 95%CI 2.4–31.4), BMI>25 (OR 3.8, 95% CI 0.43–32.5) and instability prior to arthrodesis (OR 2.51, 95% CI 0.77–8.21) were associated with non-union. All other risk factors (gender, diabetes mellitus, chronic kidney disease, peripheral vascular disease, massive bone stock loss, and immunosuppression) were not associated with arthrodesis failure. Conclusions. Staged KA for PJI in severely compromised hosts provides a functional limb free of infection and rarely results in conversion to AKA. Given our small sample size, ability to establish statistical significance of predictive factors for AKA after PJI was limited, but CKD, peripheral vascular disease, AORI III bone loss, instability, and immunosuppression trended towards significance as predictors of failure of KA after PJI predisposing to AKA


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_7 | Pages 90 - 90
1 Apr 2017
Lee G
Full Access

Infection following primary total knee arthroplasty (TKA) is fortunately a relatively uncommon complication with an incidence of approximately 1%. However, because the morbidity and cost of treatment of deep prosthetic TKA infections is so high, effective prevention strategies are key quality improvement initiatives. The cause of post-operative infections are multifactorial and complex but can generally be categorised into 1) host, 2) surgical, and 3) environmental factors. The purpose of this abstract to provide an outline of these factors and their influences on the infection risk following TKA. Patient factors and optimization of modifiable risk factors have been shown to decrease the risk for infection. While the individual contributions of factors such as body mass index (BMI), diabetes, nutritional status, Charlson Comorbidity Index (CCI), and renal disease are unknown, together, they have been shown to influence infection risk. Additionally, Tayton et al. analyzed 64,566 primary TKAs in the New Zealand Joint Registry and found that male gender and prior knee surgery were also independent risk factors of development of PJI 12 months following TKA. Finally, Crowe and colleagues also identified tobacco use and Staphylococcus aureus colonization as modifiable risk factors for minimizing PJI following primary TKA. Timely administration of prophylactic antibiotics prior and after surgery has been shown to be the most effective strategy to reduce infection risk. The optimal prophylaxis regimen for all patients is unknown and in certain situations, administration of Vancomycin in additional to a conventional cephalosporin may be beneficial. However, universal administration of Vancomycin has not been shown to decrease the incidence of surgical site infections and could actually increase the risk for renal failure. Conversely, addition of antibiotics to cement during primary TKA has not been shown to reduce long term infection risk. The use of dilute betadine lavage has been shown by some authors to be beneficial. Finally, good surgical technique, proper soft tissue handling, and meticulous wound closure are all critical factors influencing the risk for infectious complications following TKA. Environmental factors have also been shown to affect infection rates following TKA. While the use of laminar flow and body exhaust suits have not been shown to significantly influence the risk for infection, minimizing operating room traffic has been shown effective in reducing the risk for contamination. Some authors have shown ultraviolet light systems to decrease airborne contaminants. In summary, factors influencing infection risk following TKA are complex and multifactorial. Patient selection, optimization of modifiable risk factors, appropriate use of antibiotics, and minimization of OR traffic are among the most common strategies to minimizing infection


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_8 | Pages 109 - 109
1 May 2016
Klingenstein G Jain R Schoifet S Reid J Porat M
Full Access

Introduction. Rapid recovery protocols (RRP) for joint replacements have been shown to improve efficiency, reduce costs, and minimize adverse outcomes in academic health systems. The purpose of this study is to evaluate if RRP can be safely implemented in a community health system for total knee arthroplasty. Methods. This study used a retrospective cohort of 3,608 patients who underwent primary unilateral total knee arthroplasty from January 1, 2013 to December 31, 2014. 60 Patients were excluded because data or surgery could not be verified: BMI less than 18.5 or greater than 60 kg/m∘2 or if the surgical time was less than 45 seconds or greater than 180 minutes, and bilateral surgery. Data was obtained from querying the health system's inpatient database containing information for all joint replacements within the system. Patients were compared in two groups: those who received a RRP after surgery versus those who received traditional post-op care. The main outcome measure was all-cause 30-day readmissions. Multivariate logistic regression was used to calculate the odds for all-cause 30-day readmission for patients who received RRP versus traditional care when controlling for age, gender, race, insurance status (Medicare versus no Medicare), obesity, diabetes, renal disease, tobacco use, and ASA score (less than 3 versus 3 or greater). Results. Patients receiving RRP were readmitted less than those who received traditional care (1.6% versus 3.6%, p<0.001) and had a lower mean length of stay (1.5 versus 3.3 days, p<0.001). When controlling for confounding factors, the odds of 30-day readmission for patients receiving RRP versus traditional care was 0.42 (95% CI 0.26–0.66, p<0.001). Conclusions. Rapid recovery protocols are an effective means of reducing 30-day readmissions and length of stay in patients undergoing primary unilateral total knee arthroplasty in a community setting


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_17 | Pages 58 - 58
1 Nov 2016
Lee G
Full Access

Infection following primary total knee arthroplasty (TKA) is fortunately a relatively uncommon complication with an incidence of approximately 1%. However, because the morbidity and cost of treatment of deep prosthetic TKA infections is so high, effective prevention strategies are key quality improvement initiatives. The cause of post-operative infections are multifactorial and complex but can generally be categorised into 1) host, 2) surgical, and 3) environmental factors. The purpose of this abstract is to provide an outline of these factors and their influences on the infection risk following TKA. Patient factors and optimization of modifiable risk factors have been shown to decrease the risk for infection. While the individual contributions of factors such as body mass index (BMI), diabetes, nutritional status, Charlson Comorbidity Index (CCI), and renal disease are unknown, together, they have been shown to influence infection risk. Additionally, Tayton et al. analyzed 64,566 primary TKAs in the New Zealand Joint Registry and found that male gender and prior knee surgery were also independent risk factors of development of PJI 12 months following TKA. Finally, Crowe and colleagues also identified tobacco use and Staphylococcus aureus colonization as modifiable risk factors for minimizing PJI following primary TKA. Timely administration of prophylactic antibiotics prior and after surgery has been shown to be the most effective strategy to reduce infection risk. The optimal prophylaxis regimen for all patients is unknown and in certain situations, administration of Vancomycin in additional to a conventional cephalosporin may be beneficial. However, universal administration of Vancomycin has not been shown to decrease the incidence of surgical site infections and could actually increase the risk for renal failure. Conversely, addition of antibiotics to cement during primary TKA has not been shown to reduce long term infection risk. The use of dilute betadine lavage has been shown by some authors to be beneficial. Finally, good surgical technique, proper soft tissue handling, and meticulous wound closure are all critical factors influencing the risk for infectious complications following TKA. Environmental factors have also been shown to affect infection rates following TKA. While the use of laminar flow and body exhaust suits have not been shown to significantly influence the risk for infection, minimizing operating room traffic has been shown effective in reducing the risk for contamination. Some authors have shown ultraviolet light systems to decrease airborne contaminants. In summary, factors influencing infection risk following TKA are complex and multifactorial. Patient selection, optimization of modifiable risk factors, appropriate use of antibiotics, and minimization of OR traffic are among the most common strategies to minimizing infection


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_12 | Pages 69 - 69
1 Jul 2014
Barnett S
Full Access

Patient History. This patient is a 59-year-old female who presents with right side hip pain which has gradually progressed over the last 2 years. She describes activity related pain in the right groin radiating down the anterior thigh to the knee. There is also a moderate amount of posterior pain in the ischial region. She is now having pain at night as well as occasional back pain. The patient works as a landscape designer and historically has been quite active participating in yoga, snow skiing, and hiking. These activities have become more limited over the last 12 months. She denies any significant right knee pain and has no radicular complaints. Prior treatment has consisted of physical therapy on two separate occasions over the last year both for 6-week periods without relief. She uses anti-inflammatories daily but otherwise has not had any injections or surgery on the right hip. A cane is used for long distances and her maximum ambulatory capacity is 2 blocks. She is unable to negotiate stairs easily and has difficulty donning socks and shoes. Overall she describes her activity level as light labour. She has no significant past medical or surgical history and takes no medications. The patient is allergic to sulfa drugs. She denies tobacco use. By physical exam she stands 5 feet 4 inches and weighs 150 pounds. Lumbar spine exam shows no tenderness to palpation with negative straight leg raise bilaterally. Right hip exam is consistent with 95 degrees of flexion and 10 degrees extension. Abduction and adduction are 20 degrees and 10 degrees, respectively with 5 degrees of both internal and external rotation. Groin pain is reproduced with passive hip range of motion. Hip flexion and abduction strength are 5/5 with mild tenderness along the greater trochanteric region. Leg lengths are symmetrical. Right knee exam shoes full range of motion with neutral alignment and stability in both the coronal and sagittal planes. Right foot and ankle exam is consistent with normal sensory motor function and palpable dosalis pedis and posterior tibial pulses. X-ray examination demonstrates advanced degenerative changes in the right hip with complete joint space obliteration and early erosive changes in the femoral head. Bone quality shows mild osteoporosis. Impression: Osteoarthritis Right Hip. Plan: Anterior Approach Right Total Hip Arthroplasty


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 233 - 233
1 Jul 2014
Ovaska M Mäkinen T Madanat R Kiljunen V Lindahl J
Full Access

Summary. Syndesmotic malreduction or failure to restore fibular length are the leading causes for early reoperation after ankle fracture surgery. Anatomic fracture reduction and congruent ankle mortise can be achieved in the majority of cases following revision surgery. Introduction. The goal of ankle fracture surgery is to restore anatomical congruity. However, anatomic reduction is not always achieved, and residual talar displacement and postoperative malreduction predispose a patient to post-traumatic arthritis and poor functional outcomes. The present study aimed to determine the most common surgical errors resulting in early reoperation following ankle fracture surgery. Patients & Methods. We performed a chart review to determine the most common types of malreductions that led to reoperation within the first week following ankle fracture surgery. From 2002 to 2011, we identified 5123 consecutive ankle fracture operations in 5071 patients. 79 patients (1.6%) were reoperated on due to malreduction (residual fracture displacement > 2mm) detected in postoperative radiographs. These patients were compared with an equal number of age- and sex-matched control patients. Surgical errors were classified according to the anatomical site of malreduction: fibula, medial malleolus, posterior malleolus, Chaput-Tillaux fragment, and syndesmosis. Problems related to syndesmotic reduction or fixation were further divided into four categories: malreduction of the fibula in the tibiofibular incisura due to malpositioning of a syndesmotic screw, persistent tibiofibular widening (TFCS > 6 mm), positioning of a syndesmotic screw posterior to the posterior margin of the tibia, and unnecessary use of a syndesmotic screw. Results. The mean patient age was 44 years (18 to 80), and 49% were women. There were no differences between the groups regarding diabetes, tobacco use, peripheral vascular disease, or alcohol abuse. The most common indication for reoperation was syndesmotic malreduction (47 of 79 patients; 59%). Other frequent indications for reoperation were fibular shortening and malreduction of the medial malleolus. We identified four main types of errors related to syndesmotic reduction or fixation, the most common being fibular malreduction in the tibiofibular incisura. The most commonly combined errors were malreductions of the fibula and syndesmosis, which occurred together in 16 of 79 patients (20%). Fracture-dislocation (p = 0.011), fracture type (p = 0.001), posterior malleolar fracture (p = 0.005), associated medial malleolar fracture (p = 0.001), duration of index surgery (p = 0.001), and associated medial malleolar fixation other than with two parallel screws (p = 0.045) were associated with reoperation. Correction of the malreduction was achieved in 84% of reoperated cases. Conclusion. Early reoperation after ankle fracture surgery was most commonly caused by errors related to syndesmotic reduction or failure to restore fibular length. In the majority of cases, postoperative malreduction was successfully corrected in the acute setting


Bone & Joint Open
Vol. 3, Issue 6 | Pages 485 - 494
13 Jun 2022
Jaubert M Le Baron M Jacquet C Couvreur A Fabre-Aubrespy M Flecher X Ollivier M Argenson J

Aims

Two-stage exchange revision total hip arthroplasty (THA) performed in case of periprosthetic joint infection (PJI) has been considered for many years as being the gold standard for the treatment of chronic infection. However, over the past decade, there have been concerns about its safety and its effectiveness. The purposes of our study were to investigate our practice, collecting the overall spacer complications, and then to analyze their risk factors.

Methods

We retrospectively included 125 patients with chronic hip PJI who underwent a staged THA revision performed between January 2013 and December 2019. All spacer complications were systematically collected, and risk factors were analyzed. Statistical evaluations were performed using the Student's t-test, Mann-Whitney U test, and Fisher's exact test.


The Bone & Joint Journal
Vol. 104-B, Issue 4 | Pages 486 - 494
4 Apr 2022
Liu W Sun Z Xiong H Liu J Lu J Cai B Wang W Fan C

Aims

The aim of this study was to develop and internally validate a prognostic nomogram to predict the probability of gaining a functional range of motion (ROM ≥ 120°) after open arthrolysis of the elbow in patients with post-traumatic stiffness of the elbow.

Methods

We developed the Shanghai Prediction Model for Elbow Stiffness Surgical Outcome (SPESSO) based on a dataset of 551 patients who underwent open arthrolysis of the elbow in four institutions. Demographic and clinical characteristics were collected from medical records. The least absolute shrinkage and selection operator regression model was used to optimize the selection of relevant features. Multivariable logistic regression analysis was used to build the SPESSO. Its prediction performance was evaluated using the concordance index (C-index) and a calibration graph. Internal validation was conducted using bootstrapping validation.


Bone & Joint Open
Vol. 2, Issue 6 | Pages 388 - 396
1 Jun 2021
Khoshbin A Hoit G Nowak LL Daud A Steiner M Juni P Ravi B Atrey A

Aims

While preoperative bloodwork is routinely ordered, its value in determining which patients are at risk of postoperative readmission following total knee arthroplasty (TKA) and total hip arthroplasty (THA) is unclear. The objective of this study was to determine which routinely ordered preoperative blood markers have the strongest association with acute hospital readmission for patients undergoing elective TKA and THA.

Methods

Two population-based retrospective cohorts were assembled for all adult primary elective TKA (n = 137,969) and THA (n = 78,532) patients between 2011 to 2018 across 678 North American hospitals using the American College of Surgeons National Quality Improvement Programme (ACS-NSQIP) registry. Six routinely ordered preoperative blood markers - albumin, haematocrit, platelet count, white blood cell count (WBC), estimated glomerular filtration rate (eGFR), and sodium level - were queried. The association between preoperative blood marker values and all-cause readmission within 30 days of surgery was compared using univariable analysis and multivariable logistic regression adjusted for relevant patient and treatment factors.


Bone & Joint Research
Vol. 9, Issue 10 | Pages 635 - 644
1 Oct 2020
Lemaignen A Grammatico-Guillon L Astagneau P Marmor S Ferry T Jolivet-Gougeon A Senneville E Bernard L

Aims

The French registry for complex bone and joint infections (C-BJIs) was created in 2012 in order to facilitate a homogeneous management of patients presented for multidisciplinary advice in referral centres for C-BJI, to monitor their activity and to produce epidemiological data. We aimed here to present the genesis and characteristics of this national registry and provide the analysis of its data quality.

Methods

A centralized online secured database gathering the electronic case report forms (eCRFs) was filled for every patient presented in multidisciplinary meetings (MM) among the 24 French referral centres. Metrics of this registry were described between 2012 and 2016. Data quality was assessed by comparing essential items from the registry with a controlled dataset extracted from medical charts of a random sample of patients from each centre. Internal completeness and consistency were calculated.


The Bone & Joint Journal
Vol. 101-B, Issue 4 | Pages 461 - 469
1 Apr 2019
Lädermann A Schwitzguebel AJ Edwards TB Godeneche A Favard L Walch G Sirveaux F Boileau P Gerber C

Aims

The aim of this study was to report the outcomes of different treatment options for glenoid loosening following reverse shoulder arthroplasty (RSA) at a minimum follow-up of two years.

Patients and Methods

We retrospectively studied the records of 79 patients (19 men, 60 women; 84 shoulders) aged 70.4 years (21 to 87) treated for aseptic loosening of the glenosphere following RSA. Clinical evaluation included pre- and post-treatment active anterior elevation (AAE), external rotation, and Constant score.


Bone & Joint 360
Vol. 8, Issue 5 | Pages 33 - 35
1 Oct 2019


Bone & Joint 360
Vol. 6, Issue 6 | Pages 17 - 20
1 Dec 2017


Bone & Joint 360
Vol. 5, Issue 5 | Pages 25 - 27
1 Oct 2016


Bone & Joint Research
Vol. 2, Issue 6 | Pages 102 - 111
1 Jun 2013
Patel RA Wilson RF Patel PA Palmer RM

Objectives

To review the systemic impact of smoking on bone healing as evidenced within the orthopaedic literature.

Methods

A protocol was established and studies were sourced from five electronic databases. Screening, data abstraction and quality assessment was conducted by two review authors. Prospective and retrospective clinical studies were included. The primary outcome measures were based on clinical and/or radiological indicators of bone healing. This review specifically focused on non-spinal orthopaedic studies.


Bone & Joint Research
Vol. 4, Issue 9 | Pages 154 - 162
1 Sep 2015

Objective

Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-day regimen of post-operative antibiotics, in comparison to a 24-hour regimen, decreases surgical site infections in patients undergoing endoprosthetic reconstruction for lower extremity primary bone tumours.

Methods

We performed a pilot international multi-centre RCT. We used central randomisation to conceal treatment allocation and sham antibiotics to blind participants, surgeons, and data collectors. We determined feasibility by measuring patient enrolment, completeness of follow-up, and protocol deviations for the antibiotic regimens.