Functional outcome of routine versus on-demand removal of the syndesmotic screw: a multicentre randomized controlled trial.

AIMS: The aim of this study was to investigate whether on-demand removal (ODR) is noninferior to routine removal (RR) of syndesmotic screws regarding functional outcome. METHODS: Adult patients (aged above 17 years) with traumatic syndesmotic injury, surgically treated within 14 days of trauma using one or two syndesmotic screws, were eligible (n = 490) for inclusion in this randomized controlled noninferiority trial. A total of 197 patients were randomized for either ODR (retaining the syndesmotic screw unless there were complaints warranting removal) or RR (screw removed at eight to 12 weeks after syndesmotic fixation), of whom 152 completed the study. The primary outcome was functional outcome at 12 months after screw placement, measured by the Olerud-Molander Ankle Score (OMAS). RESULTS: There were 152 patients included in final analysis (RR = 73; ODR = 79). Of these, 59.2% were male (n = 90), and the mean age was 46.9 years (SD 14.6). Median OMAS at 12 months after syndesmotic fixation was 85 (interquartile range (IQR) 60 to 95) for RR and 80 (IQR 65 to 100) for ODR. The noninferiority test indicated that the observed effect size was significantly within the equivalent bounds of -10 and 10 scale points (p < 0.001) for both the intention-to-treat and per-protocol, meaning that ODR was not inferior to RR. There were significantly more complications in the RR group (12/73) than in the ODR group (1/79) (p = 0.007). CONCLUSION: ODR of the syndesmotic screw is not inferior to routine removal when it comes to functional outcome. Combined with the high complication rate of screw removal, this offers a strong argument to adopt on demand removal as standard practice of care after syndesmotic screw fixation. Cite this article: Bone Joint J 2021;103-B(11):1709-1716.

Wound infection following implant removal of foot, ankle, lower leg or patella; a protocol for a multicenter randomized controlled trial investigating the (cost-)effectiveness of 2 g of prophylactic cefazolin compared to placebo (WIFI-2 trial).

BACKGROUND: Elective implant removal (IR) after fracture fixation is one of the most common procedures within (orthopedic) trauma surgery. The rate of surgical site infections (SSIs) in this procedure is quite high, especially below the level of the knee. Antibiotic prophylaxis is not routinely prescribed, even though it has proved to lower SSI rates in other (orthopedic) trauma surgical procedures. The primary objective is to study the effectiveness of a single intravenous dose of 2 g of cefazolin on SSIs after IR following fixation of foot, ankle and/or lower leg fractures. METHODS: This is a multicenter, double-blind placebo controlled trial with a superiority design, including adult patients undergoing elective implant removal after fixation of a fracture of foot, ankle, lower leg or patella. Exclusion criteria are: an active infection, current antibiotic treatment, or a medical condition contraindicating prophylaxis with cefazolin including allergy. Patients are randomized to receive a single preoperative intravenous dose of either 2 g of cefazolin or a placebo (NaCl). The primary analysis will be an intention-to-treat comparison of the proportion of patients with a SSI at 90 days after IR in both groups. DISCUSSION: If 2 g of prophylactic cefazolin proves to be both effective and cost-effective in preventing SSI, this would have implications for current guidelines. Combined with the high infection rate of IR which previous studies have shown, it would be sufficiently substantiated for guidelines to suggest protocolled use of prophylactic antibiotics in IR of foot, ankle, lower leg or patella. Trial registration Nederlands Trial Register (NTR): NL8284, registered on 9th of January 2020, https://www.trialregister.nl/trial/8284.

Assessing Quality of Syndesmotic Reduction in Surgically Treated Acute Syndesmotic Injuries: A Systematic Review.

There is no universal method with cutoff values for the assessment of distal tibiofibular joint reduction in acute syndesmotic injuries. It is important to detect malreductions because they may lead to impaired functional outcome and may demand reoperations. The aim of this study was to systematically review the literature to evaluate the appropriateness of different image techniques in determining syndesmotic malalignment. A literature search was conducted in Medline, Embase, and the Cochrane Library to search for articles assessing syndesmotic reduction. Excluded were articles where no criteria and/or measurements for syndesmotic reduction were provided, only normative values were provided and reviews. In total, 2157 articles were found, of which 1421 studies were screened for title and abstract after exclusion of duplicates. One hundred ten studies were eligible for full-text analysis. Of these, 61 were excluded. Three studies where added after screening the included references. Fifty-two studies were included, of which 32 were original publications and 20 were publications referring to the original publications. From the original publications, 14 used plains radiographs, 19 computed tomographic (CT) scans, and 5 used 3-dimensional CT scans (some authors used >1 modality in their study). For each modality, a large number of parameters and different cutoff values were reported. CT scanning is superior to plain radiography in the assessment of the quality of joint reduction. Parameters used the most were fibular position in the incisura and fibular rotation. The criteria for adequate reduction should at least include the position of the fibula in the incisura and rotation of the fibula, while ensuring adequate fibular length, all equaling or at least approaching the values of the uninjured contralateral side.

A systematic review and meta-analysis of the sinus tarsi and extended lateral approach in the operative treatment of displaced intra-articular calcaneal fractures.

BACKGROUND: The optimal surgical approach for displaced intra-articular calcaneal fractures (DIACF) is subject of debate. The primary aim of this systematic review and meta-analysis was to assess wound-healing complications following the sinus tarsi approach (STA) compared to the extended lateral approach (ELA). Secondary aims were to assess time to surgery, operative time, calcaneal anatomy restoration, functional outcome, implant removal and injury to the peroneal tendons and sural nerve. METHODS: MEDLINE, EMBASE and Cochrane databases were searched for clinical studies comparing the STA and the ELA (until September 2017). RESULTS: Nine studies were included (two randomized controlled trials; seven comparative studies). 326 patients (331 fractures) were treated by the STA and 383 patients (390 fractures) by ELA. Ninety-nine per cent were Sanders type II/III fractures. Wound healing complications in the STA and ELA occurred in 11/331 and 82/390 fractures, respectively. Weighted means were 4.9% and 24.9%, respectively. Meta-analysis showed significantly less wound healing complications in the STA compared to ELA (risk ratio 0.20; 95% CI 0.11-0.36; P<0.00001; I2=0%). In general, time to surgery and operative time were shorter in the STA. Meta-analysis was not possible due to heterogeneity between studies. No differences were found in remaining secondary outcomes. CONCLUSIONS: The STA is associated with significantly less wound healing complications. With similar functional outcome and calcaneal anatomy restoration, the STA may be the preferred approach in the operative treatment of Sanders type II/III DIACF.

Preoperative disinfection of foot and ankle: microbiological evaluation of two disinfection methods.

BACKGROUND: The aim of the current study was to investigate the effect of a footbath in alcohol prior to preoperative disinfection on bacterial flora of the foot and ankle. METHODS: Twenty-two volunteers underwent skin preparation mimicking pre-surgical disinfection. One foot was submerged in a bag filled with 70% ethanol containing 10% IPA for 5 min after which it was painted with regular 0.5% chlorhexidine in 70% alcohol. The other foot was only painted with 0.5% chlorhexidine in 70% alcohol. Swabs were taken at four locations: (1) under the nailfold of the first toe, (2) first webspace, (3) sinus tarsi and (4) pre-tibial. A quantitative and qualitative analysis of the cultures was performed. RESULTS: No statistically significant difference between the number of positive cultures between the two methods was observed. The number of colony forming units was statistically significantly lower on two locations in the footbath group (i.e., subungual and the first webspace) (median 1 versus median 92 p =0.03 and median 0 versus median 1 p =0.03, respectively). The number of cultures with heavy growth was lower in the footbath group under the nailfold of the first toe (5 versus 13 p =0.008). Thirty-eight different microorganisms were cultured. CONCLUSION: A footbath in alcohol prior to regular preoperative skin antisepsis significantly reduces the amount of bacteria under the nailfold and in the first webspace. The number of cultures with heavy growth is lower after a footbath in alcohol. LEVEL OF EVIDENCE: IV.

Correction to: Prophylactic negative pressure wound therapy after lower extremity fracture surgery: a pilot study.

The published online version contain mistake in the author list for the name of the author "J. Carel Goslings" was incorrectly presented in the HTML version.

Prophylactic negative pressure wound therapy after lower extremity fracture surgery: a pilot study.

PURPOSE: Infectious complications following lower extremity fracture surgery are a major concern and account for a substantial socio-economic burden to society. The aim of this pilot study was to investigate the feasibility of a new portable single-use negative pressure wound therapy device in patients undergoing major foot ankle surgery. METHODS: Patients undergoing major foot ankle fracture surgery at a single level 1 trauma centre were eligible for this prospective case series. Patient characteristics were collected, as were fracture and surgical characteristics. Primary outcome was surgical site infection within 30 days as classified by the criteria from the Centers for Disease Control and Prevention. Patients in the prospective cohort were case-matched with a historical cohort from the same institution. RESULTS: Sixty patients were included. In seven patients, the NPWT failed and treatment was ceased. Mean age was 44 years and 85% was ASA 1; 43% of the patients were actively smoking. Indications for surgery were midfoot, calcaneal, talar, and ankle fractures. In 53 patients, four (7.5%) surgical site infections occurred, two superficial (3.3%) and two (3.3%) deep infections. For 47 patients, a match was available. The incidence of surgical site infection did not statistically significantly differ between the prospective cohort and retrospective matched cohort (4.3 versus 14.9%, p = 0.29, respectively). This was also the case when looking at superficial and deep surgical site infections separately (0 versus 8.5%, p = 0.08, and 4.3 versus 6.4%, respectively). CONCLUSION: We have observed surgical site infections in 7.5% of the patients with the use of prophylactic negative pressure wound therapy. The incidence of surgical site infections was not statistically significantly lower compared to a matched historical cohort.

Normative data for the Patient-Rated Wrist Evaluation questionnaire.

STUDY DESIGN: Cross-sectional study. INTRODUCTION: The Patient-Rated Wrist Evaluation (PRWE) questionnaire is used to evaluate functional outcomes after treatment of wrist and hand injuries and nontraumatic conditions. Since patients commonly present with an injury, it is impossible to assess preinjury physical functioning. Therefore, it is important to be aware of the population-based normative data. PURPOSE OF THE STUDY: The aim of this study was to determine the normative data for the PRWE questionnaire. Secondary, we aimed to determine if there were factors influencing these normative data. METHODS: Visitors and employees of 4 hospitals were requested to participate. Excluded were all participants who were scheduled for surgery or were in treatment or after treatment for an injury of the wrist or hand within 1 year after trauma. All participants were asked to complete the PRWE questionnaire and were asked for their age, sex, history of wrist or hand fracture or surgery, daily activities, and the type of employment. The socioeconomic status was determined based on the zip code. RESULTS: The median PRWE score was 0 (interquartile range: 0-8.5) and the mean score 7.7 (standard deviation: 15.0). Women had significantly higher scores compared to men, and younger individuals had significantly lower scores. Participants with a history of wrist or hand fracture or surgery, and participants who were unfit for work had significantly higher scores. Socioeconomic status was not correlated with the PRWE score. DISCUSSION: The purpose was to provide an representative overview of the normative data for the normal population. We did not want to present the data of an unnatural healthy population, which is not representative of the normal population. Deleting patients with chronic wrist or hand complaints, would have resulted in normative values which are not representable for the normal, average population. CONCLUSION: Low scores are observed for the PRWE in the general population. These scores are age and sex dependent and are higher in individuals with a history of wrist or hand fracture or surgery or who are unfit for work.

Fixation Methods for Calcaneus Fractures: A Systematic Review of Biomechanical Studies Using Cadaver Specimens.

Calcaneal fractures are notoriously difficult to treat and wound complications occur often. However, owing to the rare nature of these fractures, clinical trials on this subject are lacking. Thus, biomechanical studies form a viable source of information on this subject. With our systematic review of biomechanical studies, we aimed to provide an overview of all the techniques available and guide clinicians in their choice of method of fracture fixation. A literature search was conducted using 3 online databases to find biomechanical studies investigating methods of fixation for calcaneal fractures. A total of 14 studies investigating 237 specimens were identified. Large diversity was found in the tested fixation methods and in the test setups used. None of the studies found a significant difference in favor of any of the fixation methods. All tested methods provided a biomechanically stable fixation. All the investigated methods of fixation for calcaneal fractures seem to be biomechanically sufficient. No clear benefit was found for locking plates in the fixation of calcaneal fractures; however, a subtle mechanical superiority might exist compared with nonlocking plates in the case of fractures in osteoporotic bone. Several of the techniques tested would be suitable for a minimal invasive approach. These should be investigated further in clinical trials.

Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A Randomized Clinical Trial.

Importance: Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee. Objective: To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee. Design, Setting, and Participants: Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy. Interventions: A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). Main Outcomes and Measures: Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction. Results: Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, -1.7 [95% CI, -8.0 to 4.6], P = .60). Conclusions and Relevance: Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with saline did not reduce the risk of surgical site infection within 30 days following implant removal. Trial Registration: clinicaltrials.gov Identifier: NCT02225821.

Comparable Postoperative Pain Levels Using 2 Different Nerve Blocks in the Operative Treatment of Displaced Intra-articular Calcaneal Fractures.

BACKGROUND: The aim of this study was to compare the postoperative pain levels in patients undergoing osteosynthesis of the calcaneus with either a popliteal nerve block or an ankle block. METHODS: A retrospective analysis of all consecutive patients undergoing operative fixation of a calcaneal fracture via a sinus tarsi approach between August 2012 and April 2017 in a single foot/ankle specialized center was performed. Single-shot popliteal blocks were placed using ultrasound guidance by an anesthesiologist while ankle blocks were placed by a foot/ankle specialized surgeon. Pain levels were measured through the numerical rating scale (NRS). In total, 83 patients were included in this study; 33 received a popliteal block, and 50 received an ankle block. No statistically significant differences were present in baseline characteristics between the 2 groups. RESULTS: Comparable postoperative pain levels were observed in both groups. There was no statistically significant difference in amount of morphine used between the 2 groups. CONCLUSION: No differences were found in postoperative pain levels between patients receiving a single-shot popliteal block and patients who received a single-shot ankle block following calcaneal fracture surgery. LEVEL OF EVIDENCE: III, comparative series.

Percutaneous Intramedullary Screw Fixation of Distal Fibula Fractures: A Case Series and Systematic Review.

The current reference standard for unstable ankle fractures is open reduction and internal fixation using a plate and lag screws. This approach requires extensive dissection and wound complications are not uncommon. The use of intramedullary screw fixation might overcome these issues. The aim of our study was to provide an overview of the published data regarding intramedullary screw fixation of fibula fractures combined with a small consecutive case series. We performed a search of published studies to identify the studies in which fibula fractures were treated with percutaneous intramedullary screw fixation. Additionally, all consecutive patients treated for an unstable ankle fracture in a level 1 trauma center using an intramedullary screw were retrospectively included. The literature search identified 6 studies with a total of 180 patients. Wound infection was seen in 1 patient (0.6%), anatomic reduction was achieved in 168 patients (93.3%), and a loss of reduction was seen in 2 patients (1.1%). Implant removal was deemed necessary in 3 patients (1.7%) and nonunion was seen is 2 patients (1.1%). A total of 11 patients, in whom no wound complications occurred, were included in our study. The follow-up duration was a minimum of 12 months. A secondary dislocation was seen in 1 patient, and delayed union was observed after 7.5 months in 1 other patient. In conclusion, intramedullary screw fixation is a safe and adequate method to use for fibula fractures, with a low risk of wound complications. Additional research regarding functional outcome is warranted.

Similar Anatomical Reduction and Lower Complication Rates With the Sinus Tarsi Approach Compared With the Extended Lateral Approach in Displaced Intra-Articular Calcaneal Fractures.

OBJECTIVES: To investigate whether the sinus tarsi approach (STA) allows for a similar anatomical reduction of the posterior talocalcaneal facet as the extended lateral approach (ELA) and compare the rate of postoperative wound complications. DESIGN: Retrospective. SETTING: Level 1 trauma center. PATIENTS: All consecutive patients from 2012 to 2015 with a closed displaced intra-articular calcaneal fracture Sanders type II and III surgically treated with the ELA (N = 60) and the STA (N = 65). MAIN OUTCOME MEASUREMENTS: Wound complications, timing of surgery, operative time, length of postoperative hospitalization, and reduction of the posterior facet and calcaneal body. RESULTS: Incidence of wound complications, time to surgery, postoperative duration of hospital admission, and number of hospital admissions because of wound complications were significantly different between the ELA group and STA group. There was no significant difference in restoration of calcaneal anatomy with either approach. Importantly, the STA was performed in a median duration of 105 minutes and the ELA in a median of 134 minutes, accounting for nearly half an hour difference in operating time (P < 0.001). CONCLUSIONS: The largest benefit of the STA was found in the significant reduction in wound complications and operative time, where time to closure may have accounted for the latter difference. This difference was without a compromise in reduction. Additional studies comparing functional outcome, especially rates of subtalar arthrosis, will be needed to determine the long-term benefits of STA. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Normative data for the lower extremity functional scale (LEFS).

Background and purpose - The lower extremity functional scale (LEFS) is a well-known and validated instrument for measurement of lower extremity function. The LEFS was developed in a group of patients with various musculoskeletal disorders, and no reference data for the healthy population are available. Here we provide normative data for the LEFS. Methods - Healthy visitors and staff at 4 hospitals were requested to participate. A minimum of 250 volunteers had to be included at each hospital. Participants were excluded if they had undergone lower extremity surgery within 1 year of filling out the questionnaire, or were scheduled for lower extremity surgery. Normative values for the LEFS for the population as a whole were calculated. Furthermore, the influence of sex, age, type of employment, socioeconomic status, and history of lower extremity surgery on the LEFS were investigated. Results - 1,014 individuals fulfilled the inclusion criteria and were included in the study. The median score for the LEFS for the whole population was 77 (out of a maximum of 80). Men and women had similar median scores (78 and 76, respectively), and younger individuals had better scores. Participants who were unfit for work had worse scores. There were no statistically significant correlations between socioeconomic status and type of employment on the one hand and LEFS score on the other. A history of lower extremity surgery was associated with a lower LEFS score. Interpretation - High scores were observed for the LEFS throughout the whole population, although they did decrease with age. Men had a slightly higher score than women. There was no statistically significant correlation between socioeconomic status and LEFS score, but people who were unfit for work had a significantly worse LEFS score.

Predictors of Nonunion and Infectious Complications in Patients With Posttraumatic Subtalar Arthrodesis.

OBJECTIVE: The objective of the present study was (1) to identify predictors of both nonunion and postoperative wound infections (POWI) and (2) to assess the union and complication rate following posttraumatic subtalar arthrodesis (STA). DESIGN: Retrospective comparative cohort study. SETTING: Level 1 trauma center. PATIENTS: All consecutive adult patients with STA following traumatic injuries between 2000 and May 2015. INTERVENTION: STA for posttraumatic deformities. MAIN OUTCOME MEASUREMENTS: Union (described as a combination of radiographic signs of osseous bridging and a clinically fused joint) and POWI as classified by the Centers for Disease and Control. RESULTS: A total number of 93 (96 feet) patients met the inclusion criteria. Union was achieved in 89% of patients. For primary, secondary in situ, and secondary correction arthrodesis, these percentages were 94%, 84,% and 90%, respectively (NS). The union rate significantly increased over time (P = 0.02). In 17 patients (18%), a POWI occurred, of which 2 were classified as superficial and 15 as deep POWIs. The POWI rate did not differ between the groups. Alcohol, nicotine, and drug abuse were not significantly associated with the occurrence of POWIs. Patients with an open fracture or an infection following open reduction internal fixation had a greater risk of a POWI following STA (P = 0.03 and P = 0.04, respectively). CONCLUSIONS: We could not identify predictors for nonunion. In 18% of the patients, an infectious complication following surgery occurred. Patients with an open fracture or an infection after primary surgical treatment (ie, open reduction internal fixation) have a higher chance of POWIs following STA. The union rate following posttraumatic STA is 89%. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Validation of Six Nomograms for Predicting Non-sentinel Lymph Node Metastases in a Dutch Breast Cancer Population.

BACKGROUND: The usefulness of axillary lymph node dissection (ALND) in patients with positive sentinel nodes (SN) is still an ongoing debate. Several nomograms have been developed for predicting non-sentinel lymph node metastases (NSLNM). We validated six nomograms using data from 10 years of breast cancer surgery in our hospital. METHODS: We retrospectively analyzed all patients with a proven breast malignancy and a SN procedure between 2001 and 2011 in our hospital. RESULTS: Data from 1084 patients were reviewed; 260 (24 %) had a positive SN. No patients with isolated tumor cells, 6 patients (8 %) with micrometastases, and 65 patients (41 %) with macrometastases had additional axillary NSLNM. In 2 patients (3 %) with micrometastases, the ALND influenced postoperative treatment. In the group of patients with macrometastases tumor size >2 cm, extranodal growth and having no negative SNs were predictors of NSLNM. The revised MD Anderson Cancer Center and Helsinki nomograms performed the best, with an area under the curve value of 0.78. CONCLUSIONS: ALND could probably be safely omitted in most patients with micrometastases but is still indicated in patients with macrometastases, especially in patients with tumor size >2 cm, extranodal growth, and no negative SNs. The revised MD Anderson Cancer Center and Helsinki nomograms were the most predictive in our patient group.

Aneurysm Sac Enlargement after Endovascular Abdominal Aortic Aneurysm Repair.

The aim of this study is to give an overview of current knowledge regarding abdominal aortic aneurysm (AAA) growth after endovascular aortic aneurysm repair (EVAR) that could potentially lead to aortic rupture. A search on Pubmed was performed. A total of 705 articles were found after initial search, of which 49 were included in the final selection. Reports on the incidence of aneurysm enlargement after EVAR vary between 0.2% and 41%. Continuous growth could lead to rupture of the aneurysm sac. There are several supposed risk factors for growth after EVAR. Endoleaks remain a hot topic as these could lead to persistent pressurization of the aneurysm sac causing growth. Various types of endoleak exist, of which each kind requires an individual treatment approach, other risk factors for aneurysm growth include endotension and the use of EVAR outside instructions for use (IFU). Reinterventions after EVAR are common; however, it is unclear how frequently these are required because of aneurysm enlargement. Aneurysm enlargement after EVAR remains a subject of debate, as this could lead to aortic rupture. This emphasizes the need for life-long radiologic surveillance during follow-up. Aortic growth after EVAR is often a result of endoleak; however, in some cases, no endoleak is detectable. Endoleak in combination with aortic growth >5 mm generally requires reintervention. A cause of concern is the liberal use of endovascular devices outside the IFU that may result in increased risk of AAA growth after EVAR.

Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial.

BACKGROUND: In the Netherlands about 18,000 procedures with implant removal are performed annually following open or closed reduction and fixation of fractures, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWI) should be less than ~2%. However, rates of 10-12% following implant removal have been reported, specifically after foot, ankle and lower leg fractures. Currently, surgeons individually decide if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. The aim of the study is to assess the (cost-)effectiveness of a single intravenous gift of Cefazolin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures. METHODS: This is a double-blind randomized controlled trial in patients scheduled for implant removal following a foot, ankle or lower leg fracture. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome and costs at 30 days and 6 months after implant removal. With 2 x 250 patients a decrease in POWI rate from 10% to 3.3% (expected rate in clean-contaminated elective orthopaedic trauma procedures) can be detected (Power = 80%, 2-sided alpha = 5%, including 15% lost to follow up). DISCUSSION: If administration of prophylactic antibiotics prior to implant removal reduces the infectious complication rate, this will offer a strong argument to adopt this as standard practice of care. This will consequently lead to less physical and social disabilities and health care use. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of € 3.5 million per year. TRIAL REGISTRATION: This study is registered at Clinicaltrials.gov ( NCT02225821 ) and the Netherlands Trial Register ( NTR4393 ) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on October 7 2014.