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Background Ankle sprains and fractures are most common injuries in orthopedic and trauma surgery. The concurrent occurrence of syndesmosis ruptures in these injuries represents a more complex problem, as they often remain undetected. A proper and accurate treatment of injuries of the syndesmosis, both isolated and combined with fractures, is necessary to avoid long-term consequences (chronic instability, cartilage damage, and post-traumatic osteoarthritis). The most popular treatment option is a static screw fixation and the newly developed dynamic TightRope® (Arthrex, Naples, FL, USA). The aim of this pilot study is to compare monitor ankle range of motion and maximum ankle power in gait as functional outcome parameters of instrumented gait analysis, as well as clinical and radiographic outcome for assessing the stabilization of acute syndesmosis rupture with either a static implant (a 3.5 mm metallic screw) or a dynamic device (TightRope®). Methods This prospective, randomized, controlled, clinical trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Adult patients, who suffer from an acute syndesmosis rupture, both isolated and in combination with fractures of the lateral malleolus (Weber C and Maisonneuve fractures) and who are undergoing surgery at our trauma center will be included in our study. The patients will be randomized to the different treatment options (screw fixation or “TightRope®”). Subsequent to the surgical treatment, all patients will receive the same standardized follow-up procedures including a gait analysis and MRI of the ankle at 6 months follow-up. The primary endpoint of the study is the successful healing of the syndesmosis and biomechanical investigation with gait analysis. Discussion The results of the gait analysis from the current study will help to impartially and reliably evaluate the clinical and biomechanical outcome of both treatment options of acute syndesmosis ruptures. We hypothesize that the dynamic fixation provides an equivalent or better biomechanical, clinical, and radiographic outcome in comparison to the screw fixation. Trial registration German Clinical Trials Register (DRKS) DRKS00013562 . Registered on July, 12, 2017.

Background Posttraumatic osteoarthritis can develop after an intra-articular extremity fracture, leading to pain and loss of function. According to international guidelines, anatomical reduction and fixation are the basis for an optimal functional result. In order to achieve this during fracture surgery, an optimal view on the position of the bone fragments and fixation material is a necessity. The currently used 2D-fluoroscopy does not provide sufficient insight, in particular in cases with complex anatomy or subtle injury, and even an 18-26% suboptimal fracture reduction is reported for the ankle and foot. More intra-operative information is therefore needed. Recently the 3D-RX-system was developed, which provides conventional 2D-fluoroscopic images as well as a 3D-reconstruction of bony structures. This modality provides more information, which consequently leads to extra corrections in 18-30% of the fracture operations. However, the effect of the extra corrections on the quality of the anatomical fracture reduction and fixation as well as on patient relevant outcomes has never been investigated. The objective of this study protocol is to investigate the effectiveness of the intra-operative use of the 3D-RX-system as compared to the conventional 2D-fluoroscopy in patients with traumatic intra-articular fractures of the wrist, ankle and calcaneus. The effectiveness will be assessed in two different areas: 1) the quality of fracture reduction and fixation, based on the current golden standard, Computed Tomography. 2) The patient-relevant outcomes like functional outcome range of motion and pain. In addition, the diagnostic accuracy of the 3D-RX-scan will be determined in a clinical setting and a cost-effectiveness as well as a cost-utility analysis will be performed. Methods/design In this protocol for an international multicenter randomized clinical trial, adult patients (age > 17 years) with a traumatic intra-articular fracture of the wrist, ankle or calcaneus eligible for surgery will be subjected to additional intra-operative 3D-RX. In half of the patients the surgeon will be blinded to these results, in the other half the surgeon may use the 3D-RX results to further optimize fracture reduction. In both randomization groups a CT-scan will be performed postoperatively. Based on these CT-scans the quality of fracture reduction and fixation will be determined. During the follow-up visits after hospital discharge at 6 and 12 weeks and 1 year postoperatively the patient relevant outcomes will be determined by joint specific, health economic and quality of life questionnaires. In addition a follow up study will be performed to determine the patient relevant outcomes and prevalence of posttraumatic osteoarthritis at 2 and 5 years postoperatively. Discussion The results of the study will provide more information on the effectiveness of the intra-operative use of 3D-imaging during surgical treatment of intra-articular fractures of the wrist, ankle and calcaneus. A randomized design in which patients will be allocated to a treatment arm during surgery will be used because of its high methodological quality and the ability to detect incongruences in the reduction and/or fixation that occur intra-operatively in the blinded arm of the 3D-RX. An alternative, pragmatic design could be to randomize before the start of the surgery, then two surgical strategies would be compared. This resembles clinical practice better, but introduces more bias and does not allow the assessment of incongruences that would have been detected by 3D-RX in the blinded arm. Trial registration Dutch Trial Register NTR 1902

Purpose The purpose of this study is to propose recommendations for the treatment of patients with chronic lateral ankle instability (CAI) based on expert opinions. Methods A questionnaire was sent to 32 orthopaedic surgeons with clinical and scientific experience in the treatment of CAI. The questions were related to preoperative imaging, indications and timing of surgery, technical choices, and the influence of patient-related aspects. Results Thirty of the 32 invited surgeons (94%) responded. Consensus was found on several aspects of treatment. Preoperative MRI was routinely recommended. Surgery was considered in patients with functional ankle instability after 3–6 months of non-surgical treatment. Ligament repair is still the treatment of choice in patients with mechanical instability; however, in patients with generalized laxity or poor ligament quality, lateral ligament reconstruction (with grafting) of both the ATFL and CFL should be considered. Conclusions Most surgeons request an MRI during the preoperative planning. There is a trend towards earlier surgical treatment (after failure of non-surgical treatment) in patients with mechanical ligament laxity (compared with functional instability) and in high-level athletes. This study proposes an assessment and a treatment algorithm that may be used as a recommendation in the treatment of patients with CAI. Level of evidence V.

While only 15-20% of patients with foot and ankle injuries presenting to urgent care centers have clinically significant fractures, most undergo radiography. We examined the impact of electronic point-of-care clinical decision support (CDS) on adherence to the Ottawa Ankle Rules (OAR), as well as use and yield of foot and ankle radiographs in patients with acute ankle injury. We obtained institutional review board approval for this randomized controlled study performed April 18, 2012-December 15, 2013. All ordering providers credentialed at an urgent care affiliated with a quaternary care academic hospital were randomized to either receive or not receive CDS, based on the OAR and integrated into the physician order-entry system, with feedback at the time of imaging order. If the patient met OAR low-risk criteria, providers were advised against imaging and could either cancel the order or ignore the alert. We identified patients with foot and ankle complaints via ICD-9 billing codes and electronic health records and radiology reports reviewed for those who were eligible. Chi-square was used to compare adherence to the OAR (primary outcome), radiography utilization rate and radiography yield of foot and ankle imaging (secondary outcomes) between the intervention and control groups. Of 14,642 patients seen at urgent care during the study period, 613 (4.2%, representing 632 visits) presented with acute ankle injury and were eligible for application of the OAR; 374 (59.2%) of these were seen by control-group providers. In the intervention group, CDS adherence was higher for both ankle (239/258=92.6% vs. 231/374=61.8%, p=0.02) and foot radiography (209/258=81.0% vs. 238/374=63.6%; p<0.01). However, ankle radiography use was higher in the intervention group (166/258=64.3% vs. 183/374=48.9%; p<0.01), while foot radiography use (141/258=54.6% vs. 202/374=54.0%; p=0.95) was not. Radiography yield was also higher in the intervention group (26/307=8.5% vs. 18/385=4.7%; p=0.04). Clinical decision support, previously demonstrated to improve guideline adherence for high-cost imaging, can also improve guideline adherence for radiography - as demonstrated by increased OAR adherence and increased imaging yield.

Objectives To determine the diagnostic value of ultrasonography for complete discontinuity of the anterior talofibular ligament (ATFL), the calcaneofibular ligament (CFL) and the anterior inferior tibiofibular ligament (AITFL). Methods All acute ankle injuries in adult athletes (> 18 years old) presenting to the outpatient department of a specialised Orthopaedic and Sports Medicine Hospital within 7 days post-injury were assessed for eligibility. Using ultrasonography, one musculoskeletal radiologist assessed the ATFL, CFL and AITFL for complete discontinuity. Dynamic ultrasound measurements of the tibiofibular distance (mm) in both ankles (injured and contralateral) were acquired in the neutral position (N), during maximal external rotation (Max ER), and maximal internal rotation (Max IR). MR imaging was used as a reference standard. Results Between October 2017 and July 2019, 92 acute ankle injuries were included. Ultrasound diagnosed complete discontinuity of the ATFL with 87% (CI 74–95%) sensitivity and 69% (CI 53–82%) specificity. Discontinuity of the CFL was diagnosed with 29% (CI 10–56%) sensitivity and 92% (CI 83–97%) specificity. Ultrasound diagnosed discontinuity of the AITFL with 100% (CI 74–100%) sensitivity and 100% (CI 95–100%) specificity. Of the dynamic measurements, the side-to-side difference in external rotation had the highest diagnostic value for complete discontinuity of the AITFL (sensitivity 82%, specificity 86%; cut-off 0.93 mm). Conclusions Ultrasound has a good to excellent diagnostic value for complete discontinuity of the ATFL and AITFL. Therefore, ultrasound can be used to screen for injury of the ATFL and AITFL. Compared with ultrasound, dynamic ultrasound has inferior diagnostic value for complete discontinuity of the AITFL. Key Points • Ultrasound has a good to excellent diagnostic value for complete discontinuity of the anterior talofibular ligament (ATFL) and anterior inferior tibiofibular ligament (AITFL). • Ultrasound can be used to screen for injury of the ATFL and AITFL. • Compared with ultrasound, dynamic ultrasound has inferior diagnostic value for complete discontinuity of the AITFL.

BackgroundControversy continues with regard to the optimal postoperative care after open reduction and internal fixation of an ankle fracture. The hypothesis of this study was that postoperative treatment of an ankle fracture with a brace that allows active and passive range-of-motion exercises would improve the functional recovery of patients compared with that after conventional treatment with a cast. Thus, the purpose of this prospective, randomized study was to compare the long-term subjective, objective, and functional outcome after conventional treatment with a cast and that after use of functional bracing in the first six weeks following internal fixation of an ankle fracture.MethodsOne hundred patients with an unstable and/or displaced Weber type-A or B ankle fracture were treated operatively and then were randomly allocated to two groupsimmobilization in a below-the-knee cast (fifty patients) or early mobilization in a functional ankle brace (fifty patients) for the first six postoperative weeks. The follow-up examinations, which consisted of subjective and objective (clinical, radiographic, and functional) evaluations, were performed at two, six, twelve, and fifty-two weeks and at two years postoperatively.ResultsThere were no perioperative complications in either study group, but eight patients who were managed with a cast and thirty-three patients who were managed with a brace had postoperative complications, which were mainly related to wound-healing. Two patients in the group treated with a cast had deep-vein thrombosis. All fractures healed well in both groups. The difference between the two groups with respect to the complication rate was significant (p = 0.0005). No significant differences between the study groups were observed in the final subjective or objective (clinical) evaluation. At the two-year follow-up examination, the average score (and standard deviation) according to the ankle-rating scale of Kaikkonen et al. was 85 ± 9 points for the group treated with a cast and 83 ± 10 points for the group treated with a brace, and the average ankle score according to the system of Olerud and Molander was 87 ± 8 points and 87 ± 9 points, respectively.ConclusionsThe long-term functional outcome after postoperative treatment of an ankle fracture with a cast and that after use of a functional brace are similar. Although early mobilization with use of a functional ankle brace may have some theoretical beneficial effects, the risk of postoperative wound complications associated with this treatment approach is considerably increased compared with that after conventional cast treatment. Thus, the postoperative protocol of treatment with a functional brace requires refinement before it can be generally advocated for use after operative treatment of an ankle fracture.Level of EvidenceTherapeutic study, Level I-1b (randomized controlled trial [no significant difference but narrow confidence intervals]). See Intructions to Authors for a complete description of levels of evidence.

Computed tomography (CT) has been deemed a necessary part of management for Tillaux and triplane pediatric ankle fractures. However, no previously published study has attempted to quantify its usefulness in changing management. Six third-party, blinded orthopedic surgeons (F.A.L., E.N.K., D.M.P., K.J.K., D.S.F., K.A.E.) were randomly assigned to evaluate 24 pediatric Tillaux or triplane fractures with plain radiographs; after 6 months, they were again randomly assigned to evaluate the 24 radiographs plus CT scans, totaling 144 third-party, blinded evaluations. Intra- and interobserver agreements were assessed via correlation coefficient analysis. Evaluation of CT scans changed the original diagnosis of fracture type from Tillaux to triplane fracture in 7 (4.9%) of 144 evaluations. Inter- and intraobserver agreements regarding primary treatment plans did not significantly differ between radiographs and radiographs plus CT scans (0.5 vs 0.4, respectively; P >.05). The addition of CT did not significantly change the impression of the amount of displacement per case. By adding CT, more patients who were assigned nonoperative management were reassigned to operative treatment ( P =.033). Adding CT, although it may influence the decision to operate on Tillaux and triplane fractures, may not be as useful as previously thought.

ObjectivesTo evaluate time to return to play following surgical stabilisation of isolated unstable syndesmosis injuries in a cohort of professional male football players.MethodsAll professional football players undergoing surgery for isolated unstable syndesmosis injury (West Point grade ≥IIB) at a specialised Orthopaedic and Sports Medicine Hospital were followed up until return to play (minimum ≥6 months). Players with a stable syndesmosis, injuries older than 6 weeks, concomitant medial or lateral malleolar fracture or previous ankle surgery were excluded. During rehabilitation, time required to return to sports-specific rehabilitation, team training and first match play, were recorded.ResultsBetween January 2012 and December 2017, a total of 110 male professional football players were included. The mean time required to begin on field rehabilitation was 37±12 days, while the mean time to return to team training was 72±28 days. The first official match was played on average 103±28 days postoperatively. Multivariable analysis revealed that the severity of injury, the concomitant presence of talar cartilage injury and the age of the player were significantly associated (p<0.00001) with time to return to on field rehabilitation, team training and match play.ConclusionIn this cohort of professional football players, surgical stabilisation of isolated unstable syndesmosis injuries (West Point grade ≥IIB) allowed for relatively quick return to play. High grade injury (West Point grade III), concomitant cartilage injury and greater age were associated with longer return to play times.Level of evidenceLongitudinal observational cohort study (level II).

Purpose To compare the surgical outcomes of the two different ankle stabilization techniques. Methods This randomized controlled trial aimed to compare the outcomes of the modified Broström procedure with [calcaneofibular ligament (CFL) group] or without CFL repair [anterior talofibular ligament (ATFL) only group]. Of the 50 patients randomly assigned to two groups, 43 were followed up prospectively for ≥ 2 years (CFL group: 22 patients, 36.6 ± 13.1 months; ATFL Only group: 21 patients, 35.3 ± 11.9 months). Functional outcomes were assessed using the Karlsson–Peterson and Tegner activity level scoring systems. Anterior talar translation (ATT), talar tilt angle (TTA), and degrees of displacement of the calcaneus against the talus on stress radiographs were measured. All parameters were compared between the two groups. Multiple regression analysis setting the postoperative Karlsson–Peterson score as the dependent variable was performed to determine the significant variable. Results There were no significant differences between the two groups in functional (Karlsson–Peterson and Tegner activity level) scores at the last follow-up and their changes. There were no significant differences between the two groups in the ATT, TTA, their differences compared with the contralateral ankles, and degrees of displacement of the calcaneus against the talus at the last follow-up. Osteochondral lesion of the talus rather than CFL repair was the significant variable related to functional outcome. Conclusion The modified Broström procedure with additional CFL repair did not result in a significant advantage in any measured outcome at 3 years. Level of evidence Randomized controlled trial, Level I.

Introduction Treatment of osteochondral injuries is challenging, and no gold standard has been established. Layered cell-free scaffolds are a new treatment option for these defects. The aim of this study was to evaluate the osteochondral repair in patients treated with the MaioRegen ® scaffold, a cell-free biomimetic scaffold consisting of type I collagen and hydroxyapatite. Treatment using this scaffold has previously shown promising clinical results. Methods Ten patients with osteochondral lesions in the knee ( n  = 6) or in the talus ( n  = 4) were enrolled. The patients underwent pre-operative MRI and CT scans and were assessed at 1- and 2.5-year timescales post-operatively. The cartilage and bone formations were evaluated semi-quantitatively using the MOCART score. Knee patients were clinically evaluated using KOOS, subjective IKDC and Tegner scores, whereas ankle patients were evaluated using AOFAS Hindfoot and Tegner scores. Results Two patients were re-operated and excluded from further follow-up due to treatment failure. None of the patients had complete regeneration of the subchondral bone evaluated using CT. At 2.5 years, 6/8 patients had no or very limited (<10 %) bone formation in the defects and 2/8 had 50–75 % bone formation in the treated defect. MRI showed no improvement in the MOCART score at any time point. The IKDC score improved from 41.3 to 80.7, and the KOOS pain subscale improved from 63.8 to 90.8 at 2.5-year follow-up. No improvement was found with the remaining KOOS subscales, the Tegner or AOFAS Ankle-Hindfoot score. Conclusion Treatment of osteochondral defects in the ankle and knee joint with a biomimetic scaffold resulted in incomplete cartilage repair and poor subchondral bone repair at 1- and 2.5-year follow-up. Clinical significant improvements were observed. These results raise serious concerns about the biological repair potential of the MaioRegen ® scaffold, and we advise to use the MaioRegen ® scaffold with caution. Level of evidence Prospective therapeutic study, Level IV.