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After surgery for a broken ankle, patients are usually instructed to avoid walking for 6 weeks (delayed weight-bearing). Walking 2 weeks after surgery (early weight-bearing) might be a safe and preferable rehabilitation strategy. This study aimed to determine the clinical and cost effectiveness of an early weight-bearing strategy compared with a delayed weight-bearing strategy. This was a pragmatic, multicentre, randomised, non-inferiority trial including 561 participants (aged ≥18 years) who received acute surgery for an unstable ankle fracture in 23 UK National Health Service (NHS) hospitals who were assigned to either a delayed weight-bearing (n=280) or an early weight-bearing rehabilitation strategy (n=281). Patients treated with a hindfoot nail, those who did not have protective ankle sensation (eg, peripheral neuropathy), did not have the capacity to consent, or did not have the ability to adhere to trial procedures were excluded. Neither participants nor clinicians were masked to the treatment. The primary outcome was ankle function measured using the Olerud and Molander Ankle Score (OMAS) at 4 months after randomisation, in the per-protocol population. The pre-specified non-inferiority OMAS margin was –6 points and superiority testing was included in the intention-to-treat population in the event of non-inferiority. The trial was prospectively registered with ISRCTN Registry, ISRCTN12883981, and the trial is closed to new participants. Primary outcome data were collected from 480 (86%) of 561 participants. Recruitment was conducted between Jan 13, 2020, and Oct 29, 2021. At 4 months after randomisation, the mean OMAS score was 65·9 in the early weight-bearing and 61·2 in the delayed weight-bearing group and adjusted mean difference was 4·47 (95% CI 0·58 to 8·37, p=0·024; superiority testing adjusted difference 4·42, 95% CI 0·53 to 8·32, p=0·026) in favour of early weight-bearing. 46 (16%) participants in the early weight-bearing group and 39 (14%) in the delayed weight-bearing group had one or more complications (adjusted odds ratio 1·18, 95% CI 0·80 to 1·75, p=0·40). The mean costs from the perspective of the NHS and personal social services in the early and delayed weight-bearing groups were £725 and £785, respectively (mean difference –£60 [95% CI –342 to 232]). The probability that early weight-bearing is cost-effective exceeded 80%. An early weight-bearing strategy was found to be clinically non-inferior and highly likely to be cost-effective compared with the current standard of care (delayed weight-bearing). National Institute for Health and Care Research (NIHR), NIHR Barts Biomedical Research Centre, and NIHR Applied Research Collaboration Oxford and Thames Valley.

This study investigated the effectiveness of 3D printing technology in combination with personalized custom-made steel plates in the treatment of complex distal intra-articular trimalleolar fractures, with the aim of providing a new approach to improve ankle joint function in patients. The 48 patients with complex distal intra-articular trimalleolar fractures included in the study were randomly divided into two groups: the personalized custom-made steel plate group (n = 24) and the conventional steel plate group (n = 24). A comparison was made between the two groups in terms of preoperative preparation time, hospitalization duration, surgical time, fracture reduction and internal fixation time, intraoperative fluoroscopy instances, surgical incision length, fracture healing time, follow-up duration, degree of fracture reduction, ankle joint functional recovery, and the occurrence of complications. The personalized steel plate group exhibited longer preoperative preparation time and hospitalization duration compared to the conventional steel plate group (p < 0.001). However, the personalized steel plate group demonstrated significantly shorter surgical duration, time for fracture reduction and internal fixation, reduced intraoperative fluoroscopy frequency, and a shorter overall surgical incision length (p < 0.001). Both groups displayed similar fracture healing times and follow-up durations (p > 0.05). The personalized steel plate group showed a higher rate of successful fracture reduction (87.5% vs. 79.2%, p > 0.05) and a lower incidence of complications (8.3% vs. 20.8%, p = 0.22), although these differences did not reach statistical significance. Furthermore, the personalized steel plate group exhibited superior ankle joint function scores during follow-up compared to the conventional steel plate group (p < 0.05). By utilizing 3D printing technology in conjunction with personalized custom-made steel plates, personalized treatment plans are provided for patients with complex comminuted tri-malleolar ankle fractures, enabling safer, more efficient, and satisfactory orthopedic surgeries.

IntroductionThe Olerud Molander Ankle Score (OMAS) is a widely used validated Patient Reported Outcome Measure (PROM). For clinical research, it is important to determine the Minimal Clinically Important Difference (MCID). The objective of this study was to determine the MCID of the OMAS at several moments in the follow-up, in a cohort of patients that underwent open reduction and internal fixation of unstable ankle fractures with syndesmotic injury.Materials and methodsData for this descriptive study were extracted from a prospective randomized controlled trial, the RODEO trial. The Dutch version of the OMAS was completed at 3, 6 and 12-month follow-up and estimated at baseline. The used anchor-based methods were: mean change and ROC curve. The distribution-based methods were: 0.5SD and minimal detectable change (MDC).ResultsThis cohort included 148 patients. The mean OMAS score in the group with minimal improvement between 3 and 6 months was 15.0 (SD 17.5, 95%CI 9.4–20.6) and between 6 and 12 months 9.5 (SD 17.1, 95% CI 3.1–15.9). The ROC curve between 3 and 6 months resulted in a MCID of 12.5 (AUC 0.72) and between 6 and 12 months, the MCID was 7.5 (AUC 0.78). Using 0.5 SD, the MCID was 10.52 (SD 21.04) at 3 months, 11.37 (SD 22.73) at 6 months and 10.47 (SD 20.94) at 12 months. The MDC was 4.72 at 3 months, 5.20 at 6 months and 4.71 at 12 months. ConclusionsThe calculated MCID in patients following surgery for unstable ankle fractures ranges from 10.5 to 15.0 at 3–6-month follow-up and from 7.5 to 11.4 at 6–12-month follow-up, depending on moment and method.

There is limited understanding of how well patients adhere to postoperative instructions following ankle surgery, particularly in outpatient settings regarding partial weight bearing (15–30 kg) and orthosis use. This study aims to assess orthosis compliance and load frequency over six weeks post-surgery using pressure-sensitive insoles, while also evaluating the effectiveness of continuous biofeedback. A total of 84 patients with isolated ankle fractures were enrolled. All participants were instructed to maintain partial weight bearing of 15–30 kg for six weeks with a lower leg orthosis equipped with insoles that continuously recorded daily step counts and maximum loads. In a prospective randomized design, the control group received no biofeedback, while the intervention group received audiovisual feedback whenever loads exceeded 20 kg. Adherence to the prescribed partial weight bearing and orthosis use was low in both groups, with only 10% of the control group wearing the orthosis by week three and overload occurring as early as week one. However, the implementation of biofeedback resulted in significant improvements in orthosis utilization (57.4% vs. 29.1%) and adherence to prescribed loading. The implementation of continuous biofeedback significantly enhanced adherence to prescribed loading and orthosis usage, highlighting its critical role in postoperative rehabilitation for ankle fractures.

Background Displaced ankle fractures classified as Weber types B and C are common across all age groups. The standard treatment involves open reduction and internal fixation, followed by a rehabilitation program that includes 6 weeks of partial weightbearing. During this period, both passive and active range-of-motion exercises are performed under the supervision of a physiotherapist. Recently, a new device has become available, allowing active controlled motion of the ankle joint at home on top of the normal rehabilitation protocol. The purpose of this controlled randomized trial was to evaluate the superiority of this device as a supplement in standard rehabilitation protocols after distal fibular fractures. Methods This prospective controlled multicenter trial will include a minimum of 58 patients who have undergone surgical treatment for isolated distal fibular fractures of Weber types B and C. These patients will be randomized into 2 groups: Group 1 will undergo a standardized rehabilitation protocol with active and passive physiotherapy under partial weightbearing for 6 weeks with the active controlled motion device at home on top. Group 2 will receive the same rehabilitation without the device. Three German hospitals with different levels of care and 6 rehabilitation centers are involved in this study. The estimated study duration of 12 months started in October 2024. The follow-up will last 6 months after the recruitment of the last patient. The following assessments are performed: baseline after surgery; after 6 weeks; at 3 and 6 months; and with check-in calls after 2 and 4 weeks. The evaluation of effectiveness is based on FAOS, NRS, and SF-36 scores; changes in employment during the study; return-to-work; return-to-sports; and time-to-unrestricted weightbearing. Discussion This trial aims to collect valid data to determine whether the use of an active controlled motion device as a supplement to a standardized physiotherapy protocol after surgical treatment of ankle fractures leads to significantly improved outcomes. After evaluation of the results by the German Joint Federal Committee, a final assessment is made to make this device part of a future treatment protocol in the aftercare of surgically treated distal fibular fractures of Weber types B and C. Trial registration The trial is registered in the International Clinical Trials Registry Platform of the World Health Organization with the Main-ID DRKS00034202 on July 22nd, 2024 ( https://trialsearch.who.int/Trial2.aspx ?TrialID=DRKS00034202).

To evaluate the effect of 3D printing in treating trimalleolar fractures and its roles in physician-patient communication, thirty patients with trimalleolar fractures were randomly divided into the 3D printing assisted-design operation group (Group A) and the no-3D printing assisted-design group (Group B). In Group A, 3D printing was used by the surgeons to produce a prototype of the actual fracture to guide the surgical treatment. All patients underwent open reduction and internal fixation. A questionnaire was designed for doctors and patients to verify the verisimilitude and effectiveness of the 3D-printed prototype. Meanwhile, the operation time and the intraoperative blood loss were compared between the two groups. The fracture prototypes were accurately printed, and the average overall score of the verisimilitude and effectiveness of the 3D-printed prototypes was relatively high. Both the operation time and the intraoperative blood loss in Group A were less than those in Group B ( P < 0.05 ). Patient satisfaction using the 3D-printed prototype and the communication score were 9.3 ± 0.6 points. A 3D-printed prototype can faithfully reflect the anatomy of the fracture site; it can effectively help the doctors plan the operation and represent an effective tool for physician-patient communication.

Background In the modern western world appraisal of economical points such as treatment and disability after trauma present a financial burden. In this context open reduction internal fixation techniques allowing for early full weight bearing might not only improve the clinical outcome but also shorten the period of disability in working life. The aim of the study was to analyze whether ORIF of ankle fractures using either a standard semitubular plate or a new polyaxial locking plate system result in a better clinical outcome. Methods In this prospective study, all patients with distal fibula fractures (AO 44 B1.1, B1.2, B1.3), with indication for surgery were included. Patients were randomized to either the DePuy Synthes® one-third semitubular plate (Group I) or NEWCLIP TECHNICS, Active Ankle® polyaxial locking plate (Group II). Primary outcome parameter was function of the ankle joint, assessed by the Olerud and Molander ankle score, Foot and Ankle outcome score and Karlsson and Peterson Scoring System for Ankle function. Secondary outcome parameter were postoperative complications. Superficial wound infection, delayed wound healing, mechanically prominent implant, skin irritations were considered as minor and deep wound infection, material loosening, loss of reduction were regarded as major complications requiring revision surgery. Clinical and radiological follow-up were performed 6 and 12 weeks, 6 months and 1 year postoperatively. Results Fifty-two patients (31 W/21 M) with a mean age of 43 yrs. (range 22–64 yrs.) were enrolled. Seven patients (13.5%) were excluded, so that 45 patients were available for follow up. Twenty-five patients were treated with DePuy Synthes® one-third semitubular plate (55.6%; group I) while 20 patients received an anatomically preformed polyaxial locking plate (44.4%, group II). Four minor complications occurred in Group I (16%) compared to two minor complications in group II (10%). Significant better clinical results regarding OMAS ( p  < 0.02, < 0.04), KPSS ( p  < 0.04) and FAOS ( p  < 0.02, < 0.03) were observed 6 and 12 weeks after surgery in group II. Conclusions The results of the presented study demonstrate a significant better clinical functional outcome in the early postoperative follow-up in patients treated with a polyaxial locking plate. Furthermore, our data show that ORIF using polyaxial locking plates in combination with an early postoperative weight bearing presents a safe, stable treatment option for ankle fractures so that patients benefit especially in the early stages of recovery. Trial registration Registered 20 April 2020, retrospectively on ClinicalTrails.gov ( NCT04370561 ).

PurposeThe goal of this study was to assess if unprotected weight-bearing as tolerated is superior to protected weight-bearing and unprotected non-weight-bearing in terms of functional outcome and complications after surgical fixation of Lauge-Hansen supination external rotation stage 2–4 ankle fractures.MethodsA multicentered randomized controlled trial was conducted in patients ranging from 18 to 65 years of age without severe comorbidities. Patients were randomized to unprotected non-weight-bearing, protected weight-bearing, and unprotected weight-bearing as tolerated. The primary endpoint of the study was the Olerud Molander Ankle Score (OMAS) 12 weeks after randomization. The secondary endpoints were health-related quality of life using the SF-36v2, time to return to work, time to return to sports, and the number of complications.ResultsThe trial was terminated early as advised by the Data and Safety Monitoring Board after interim analysis. A total of 115 patients were randomized. The O’Brien–Fleming threshold for statistical significance for this interim analysis was 0.008 at 12 weeks. The OMAS was higher in the unprotected weight-bearing group after 6 weeks c(61.2 ± 19.0) compared to the protected weight-bearing (51.8 ± 20.4) and unprotected non-weight-bearing groups (45.8 ± 22.4) (p = 0.011). All other follow-up time points did not show significant differences between the groups. Unprotected weight-bearing showed a significant earlier return to work (p = 0.028) and earlier return to sports (p = 0.005). There were no differences in the quality of life scores or number of complications.ConclusionsUnprotected weight-bearing and mobilization as tolerated as postoperative care regimen improved short-term functional outcomes and led to earlier return to work and sports, yet did not result in an increase of complications.

Background The optimal method for the reduction and fixation of posterior malleolar fracture (PMF) remains inconclusive. Currently, both of the indirect and direct reduction techniques are widely used. We aimed to compare the reduction quality and clinical outcome of posterior malleolar fracture managed with the direct reduction technique through posterolateral approach or the indirect reduction technique using ligamentotaxis. Methods Patients with a PMF involving over 25% of the articular surface were recruited and assigned to the direct reduction (DR) group or the indirect reduction (IR) group. Following reduction and fixation of the fracture, the quality of fracture reduction was evaluated in post-operative CT images. Clinical and radiological follow-ups were performed at 6 weeks, 3 months, 6 months, 12 months, and then at 6 month-intervals postoperatively. Functional outcome (AOFAS score), ankle range of motion, and Visual Analog Scale (VAS) were evaluated at the last follow-up. Statistical differences were compared between the DR and IR groups considering the patient demographics, quality of fracture reduction, AOFAS score, and VAS. Results Totally 116 patients were included, wherein 64 cases were assigned to the DR group and 52 cases were assigned to the IR group. The quality of fracture reduction was significant higher in the DR group ( P  = 0.038). In the patients who completed a minimum of 12 months’ follow-up, a median AOFAS score of 87 was recorded in the DR group, which was significantly higher than that recorded in the IR group (a median score of 80). The ankle range of motion was slightly better in the DR group, with the mean dorsiflexion restriction recorded to be 5.2° and 6.1° in the DR and IR group respectively ( P  = 0.331). Similar VAS score was observed in the two groups ( P  = 0.419). Conclusions The direct reduction technique through a posterolateral approach provide better quality of fracture reduction and functional outcome in the management of PMF over 25% of articular surface, as compared with the indirect reduction technique using ligamentotaxis. Trial registration NCT02801474 (retrospectively registered, June 2016, ClinicalTrails.gov).

Different fixation modalities are available for fixation of posterior malleolar fractures (PMFs), but the best method is still unclear. The purpose of this study was to carry out a comparative biomechanical analysis of three commonly used fixation constructs for PMFs using experimental and finite element analysis (FEA). 15 human cadaveric ankle specimens were randomly divided into three groups. Specimens in group-A were fixed with two anteroposterior (AP) lag screws, group-B with two posteroanterior (PA) lag screws, and for group-C, a posterior plate was used. Each model was subjected to axial load. Outcomes included loads for 0.5 mm, 1 mm, 1.5 mm, and 2 mm vertical displacements of posterior fragments were noted. 3D FE models were reconstructed from computed tomography (CT) images and subjected to vertical loads. The model’s stress, fracture step-off, and resultant strains in implants were also studied in 3D FE models. Significantly higher amounts of mean compressive loads were observed to cause the same amount of vertical displacements in plate group (265 ± 60.21 N, 796 ± 57.27 N, 901.18 ± 8.88 N, 977.26 ± 13.04 N) than AP (102.7 ± 16.78 N, 169.5 ± 19.91 N, 225.32 ± 15.92 N, 269.32 ± 17.29 N) and PA (199.88 ± 31.43 N, 362.80 ± 28.46 N, 431.3 ± 28.12 N, 541.86 ± 36.05 N) lag screws respectively (P < 0.05). Simulated micro-motion analysis demonstrated that fracture step-off values in plate group (0.03 ± 0.001 mm, 0.06 ± 0.003 mm and 0.13 ± 0.010 mm) were the lowest among the three groups (P < 0.001). The cancellous bone showed the highest amount of stress in AP and PA lag groups respectively, whereas the lowest stress was noted in the plate-group. This biomechanical study concluded that posterior plating is biomechanically the most stable fixation construct for PMFs fixation. AP and PA lag screws with higher bone stress and fracture step-off values have a high tendency of bone cut-through and loss of fixation respectively.