Recurrence rates for surgically treated insertional Achilles tendinopathy.

INTRODUCTION: Insertional Achilles tendinopathy (IAT) is a challenge for every orthopedic surgeon. Although surgical intervention is difficult to avoid after frustrating conservative therapy, little is known about recurrence of this disorder. Therefore the aim of the study was to assess the recurrence rate after primary IAT surgery. MATERIALS AND METHODS: The authors previous published cohort on primary IAT surgery was reanalyzed. Patients with a follow-up Foot and Function Index (FFI) at one year and final follow-up were included. IAT recurrence was defined as a FFI worsening between one year and final follow-up of > 6.5 points. General demographics, surgical details, complications, and the patient reported outcome (PROM) were assessed. RESULTS: Out of 58 included patients (51 ± 14 years), 8 patients (14%) suffered IAT recurrence after an average of 50 ± 25 months. None of the assessed factors was predictive for an IAT recurrence. CONCLUSION: IAT recurrence after primary surgery occurs in up to 14% of patients. LEVEL OF EVIDENCE: IV, retrospective cohort study.

Acute, isolated fractures of the metatarsal bones: an epidemiologic study.

INTRODUCTION: Although metatarsal fractures are common, the significance of previous epidemiologic studies is limited to specific fracture entities, subpopulations, or heterogeneous fracture aetiologies. The aim of the study was to assess the epidemiology of isolated metatarsal fractures in an adult population at a level-1 trauma centre. MATERIALS AND METHODS: Radiological and clinical databases were searched for a five-year period. Eligible were all patients with acute isolated metatarsal fractures over the age of 18 years with radiographs in two planes available. Stress fractures, injuries affecting Lisfranc joint stability, and concomitant injuries to other regions than the metatarsals were excluded. Data collection included general demographics, mechanism of injury, season of the trauma and fracture details. RESULTS: Out of 3259 patients, 642 patients met the inclusion criteria and were included for the analysis. The patients' mean age was 44.5 ± 18.9 years, 50.6% were female. 83.3% suffered an isolated, 16.7% multiple metatarsal fractures. Single metatarsal fractures occurred predominantly at the fifth metatarsal bone (81.3%), their frequency decreased with increasing age, with a seasonal peak during the summer. Patients suffering multiple metatarsal fractures were significantly older (51.6 ± 21.2 vs. 43.0 ± 18.1 years; p < 0.001) and the injury resulted significantly more often from a high-energy trauma (6.7% vs. 23.4%; p < 0.001). Multiple metatarsal fractures occurred evenly throughout all metatarsals but revealed a focus on female population with no seasonal differences. CONCLUSION: Single metatarsal fractures predominantly occurred at the fifth metatarsal bone and showed a seasonal, gender and age dependency. Multiple metatarsal fractures were homogeneously distributed between the different metatarsals with distinct age-dependent gender differences. LEVEL OF EVIDENCE: Level III.

Do pre-operative radiologic assessment predict postoperative outcomes in patients with insertional Achilles tendinopathy?: a retrospective database study.

INTRODUCTION: Diagnosis and treatment of insertional tendinopathy of the Achilles tendon (IAT) remains a challenge. The aim of this study was to assess the influence of pre-operative radiological pathologies on the patient-reported outcomes following open debridement of all pathologies for IAT. MATERIALS AND METHODS: In this IRB-approved retrospective correlation and comparative study, patients with pre-operative imaging were identified from the authors' retrospective IAT database comprising of 118 patients. All were treated by a standardized surgical treatment strategy utilizing a midline, transachillary approach and debridement of all pathologies. A total of fifteen radiologic parameters were measured on radiographs (RX) and MRI. The patient-reported outcomes were assessed using the Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A-G) and the general health questionnaire SF-12 at a minimum follow-up of 12 months. The data are presented as mean ± SD (95% CI). RESULTS: 88 patients (74.6%) with an average age of 50 ± 12 (47-52) years were included. Radiographs were available in 68 patients and MRI in 53. The mean follow-up was 3.8 ± 1.9 (3.4-4.3) years. The overall VISA-A-G was 81 ± 22 (77-86), the SF-12 PCS 54 ± 7 (52-55), and the SF-12 MCS 52 ± 9 (50-54) points. None of the assessed radiological parameters had a significant influence on the patient-reported outcome following surgical treatment for IAT. CONCLUSION: In this retrospective correlation study, no significant association was found between preoperative radiographic and MRI radiologic parameters for IAT and postoperative patient-reported outcomes (VISA-A-G and SF-12).

Trends of incidence and treatment strategies for operatively treated distal fibula fractures from 2005 to 2019: a nationwide register analysis.

INTRODUCTION: Valid epidemiological data about distal fibular fractures and their treatment strategies are missing. Innovative osteosynthesis techniques were introduced and improved during the past 15 years. The aim of this study was to investigate the epidemiologic development and the implementation of new treatment strategies in a nationwide register in Germany over a period of 15 years. MATERIALS AND METHODS: Data of the German Federal Statistical Office from 2005 until 2019 were screened. Adults with a fracture of the distal fibula were included. Data were separated for gender, age and treatment strategy. RESULTS: During the past 15 years, there was a steady annual incidence of distal fibula fractures of 74 ± 32 per 100,000 people without any significant changes (p = 0.436). 60.1% ± 0.6% of all fractures occurred in females. The annual incidence for male was nearly constant over the different age groups, whereas for female, there was a clear increase in incidence above the age of 40. Whereas 66% of fractures in between 20 and 30 years of age occurred in male, approximately 70% of fractures above the age of 60 occurred in females. The relative quantity of locking plates increased from 2% in 2005 to 34% in 2019. In 2019, only 1.02% of the patients were operated with an intramedullary nail. CONCLUSIONS: Operatively treated distal fibular fractures revealed an age dependent increase in incidence in postmenopausal women compared to younger females. Regarding the treatment strategy, there was an increase in application of locking plates. The data implicate a typical fragility fracture related age and gender distribution for distal fibula fractures.

Acute, isolated and unstable syndesmotic injuries are frequently associated with intra-articular pathologies.

PURPOSE: Although simultaneous arthroscopy for the surgical treatment of acute isolated, unstable syndesmotic injuries has been recommended, little knowledge is present about the actual frequency of intra-articular pathologies for this injury. The aim of this study was to investigate the frequency and severity of intra-articular pathologies detected during arthroscopy and their subsequent treatment in acute isolated, unstable syndesmotic injuries. METHODS: A retrospective chart review of patients treated by arthroscopic-assisted stabilization for acute isolated, syndesmotic instability was performed. The primary outcome parameter was the frequency of intra-articular pathologies. Secondary outcome parameters were the type of syndesmotic lesion (ligamentous/bony), severity of chondral lesions, MRI findings, treatment details, complications and the identification of factors associated with intra-articular pathologies. RESULTS: Twenty-seven patients, 19% female, with a mean age of 37 ± 12 years met the inclusion criteria. 70% suffered isolated ligamentous injuries, the remaining suffered avulsion fractures of the syndesmosis. Chondral lesions occurred in 48% (ICRS grade II: 33%; ICRS grade IV 15%) and intra-articular loose bodies in 11% of patients. Overall, arthroscopy revealed intra-articular pathologies necessitating further treatment in 19% of patients. Neither the type of syndesmotic injury (bony vs. ligamentous; ns) nor the degree of ligamentous instability (West Point IIB vs. III; ns) had a significant influence on the occurrence of chondral lesions. One complication (SSI) occurred. Pre-operative MRI revealed a sensitivity/specificity of 100/79% for chondral lesions and 50/93% for loose bodies. CONCLUSION: Intra-articular pathologies in acute isolated, unstable syndesmotic injuries occur in up to 50% of patients, 19% necessitated additional treatment. Simultaneous arthroscopy, independent of the pre-operative MRI findings, appears reasonable in highly active patients. LEVEL OF EVIDENCE: Level III.

How Does Wearing a Facecover Influence the Eye Movement Pattern in Times of COVID-19?

BACKGROUND: Since the emergence of the COVID-19 pandemic facecovers have become a common sight. The effect of facecovers on the gaze when looking at faces has not yet been assessed. OBJECTIVES: The aim of the present study was to investigate any potential differences in eye movement pattern in observers exposed to images showing a face without and with a facecover to identify if there is truly a change of gaze when identifying (masked) facial features. METHODS: The eye movement of 64 study participants (28 males and 36 females) with a mean [standard deviation] age of 31.84 [9.0] years was analyzed in this cross-sectional observational study. Eye movement analysis was conducted based on positional changes of eye features within an x- and y-coordinate system while two images (face without/with facecover) were displayed for 8 seconds. RESULTS: The results of this study revealed that the sequence of focusing on facial regions was not altered when wearing a facecover and followed the sequence: perioral, nose, periorbital. Wearing a facecover significantly increased the time spent focusing on the periorbital region and also increased the number of repeated eye fixations during the 8-second visual stimulus presentation. No statistically significant differences were observed between male and female participants in their eye movement pattern across all investigated variables (P > 0.433). CONCLUSIONS: The altered eye movement pattern caused by wearing facecoverings that this study has revealed suggests that, during the COVID-19 pandemic, aesthetic practitioners might consider developing marketing and treatment strategies that principally target the periorbital area.

Clinical outcome and concomitant injuries in operatively treated fractures of the lateral process of the talus.

BACKGROUND: The aim of this study was to review the patient rated outcome (PROM) of surgically treated fractures to the lateral process of the talus (LPTF) and identify factors influencing the outcome. METHODS: Retrospective study with a current follow-up. Eligible were all patients treated surgically for a LPTF (n = 23) with a minimum follow-up of one year. Demographics, medical history, trauma mechanism, fracture characteristics, concomitant injuries, treatment details, complications, return to work and sports were assessed retrospectively. The current follow-up included the VAS FA, Karlsson Score, and SF-12. The primary outcome was the VAS FA. Secondary aim was the identification of parameters influencing the PROMs. RESULTS: 22 patients (96% follow-up) with a mean age of 32 ± 9 (18 to 49) years were included. 73% suffered a Hawkins Type 1, 23% a Type 2, and one patient a Type 3 fracture. 82% suffered concomitant injuries. 9% suffered minor surgical side infections, 50% developed symptomatic subtalar osteoarthritis. At final follow-up (44 ± 2 (12 to 97) months), the mean VAS FA Overall was 77 ± 21 (20 to 100), the Karlsson Score 72 ± 21 (34 to 97), and for the SF 12 the PCS 53 ± 8 (36 to 64) and the MCS 53 ± 7 (32 to 63). 50% of patients returned to their previous level of sports. Hawkins Type 1 fractures resulted in better VAS FA Overall score than Type 2 fractures. Posttraumatic subtalar osteoarthritis was the independent factor associated to a poor patient rated outcome (VAS FA, Karlsson Score). CONCLUSION: After a follow-up of over 3.5 years, surgically treated LPTF resulted in only moderate results. 50% suffered posttraumatic symptomatic subtalar osteoarthritis, which was the primary independent parameter for a poor outcome following LPTF. LEVEL OF EVIDENCE: Level III.

Developmental Transformation and Reduction of Connective Cavities within the Subchondral Bone.

It is widely accepted that the subchondral bone (SCB) plays a crucial role in the physiopathology of osteoarthritis (OA), although its contribution is still debated. Much of the pre-clinical research on the role of SCB is concentrated on comparative evaluations of healthy vs. early OA or early OA vs. advanced OA cases, while neglecting how pure maturation could change the SCB's microstructure. To assess the transformations of the healthy SCB from young age to early adulthood, we examined the microstructure and material composition of the medial condyle of the femur in calves (three months) and cattle (18 months) for the calcified cartilage (CC) and the subchondral bone plate (SCBP). The entire subchondral zone (SCZ) was significantly thicker in cattle compared to calves, although the proportion of the CC and SCBP thicknesses were relatively constant. The trabecular number (Tb.N.) and the connectivity density (Conn.D) were significantly higher in the deeper region of the SCZ, while the bone volume fraction (BV/TV), and the degree of anisotropy (DA) were more affected by age rather than the region. The mineralization increased within the first 250 µm of the SCZ irrespective of sample type, and became stable thereafter. Cattle exhibited higher mineralization than calves at all depths, with a mean Ca/P ratio of 1.59 and 1.64 for calves and cattle, respectively. Collectively, these results indicate that the SCZ is highly dynamic at early age, and CC is the most dynamic layer of the SCZ.

Comparison of arthroscopic to open tibiotalocalcaneal arthrodesis in high-risk patients.

BACKGROUND: Open tibiotalocalcaneal arthrodesis (TTCA) is associated to high complication rates, which led to the development of arthroscopic techniques. Aim was to compare complication rates of open to arthroscopic TTCA in high-risk patients. METHODS: Single-center, retrospective case-control study. Patients were selected from the authors' TTCA database. Eligible were high-risk patients receiving arthroscopic-, or open TTCA retrospectively suitable for arthroscopic TTCA. Primary outcome were major complications. RESULTS: Eight open and 15 arthroscopic TTCAs were included. Three open and 4 arthroscopic TTCAs presented preoperative plantar ulceration. Fusion rates were similar (75% vs. 67%; p=0.679). Major complications occurred in 63% of open (80% surgical-site-infections (SSI)) and 33% of arthroscopic (100% non-unions) TTCA. Preoperative plantar ulceration did not affect major SSI in open TTCA (67% vs. 60%) but resulted in a significant increase of non-union rates for arthroscopic TTCA (75% vs. 18%; p=0.039). In patients without plantar ulceration the union-rate was 80% for both, open and arthroscopic TTCA. CONCLUSION: Arthroscopic TTCA drastically reduced major SSI. Patients without preexisting ulceration had excellent union-rates for open and arthroscopic TTCA.

Influence of age and level of activity on the applicability of a walker orthosis - a prospective study in different cohorts of healthy volunteers.

BACKGROUND: Walker orthosis are frequently prescribed as they are removable to allow wound control, body care and physiotherapy and are adaptable to the soft tissue conditions. The prerequisite for successful treatment with any walker orthosis is a correct use by the patient. Therefore, the aim of this study was to investigate patients' handling of a commonly used walker. METHODS: Prospective observational study analyzing the applicability of a walker orthosis in different cohorts with varying age and level of activity. Volunteers were recruited from a mountain-biking-team (Sport), a cardiovascular-health-sports-group (Cardio) and a retirement home (Senior). The correct application was assessed following initial training (t0) and one week later (t1). Outcome parameters were an Application Score, strap tightness, vertical heel lift-off and subjective judgement of correct application. RESULTS: Thirty-three volunteers, 11 Sports group (31 ± 7a), 12 Cardio group (59 ± 11a), 10 Senior group, (82 ± 5a) were enrolled. No differences for any parameter could be observed between t0 and t1. Age showed a moderate correlation for all outcome parameters and the cohort influenced all variables. The Senior group presented significant inferior results to the Sport- and Cardio group for the Application Score (p = 0.002-p < 0.001) and strap tightness (p < 0.001). Heel lift-off was significantly inferior in the Cardio- and Senior- compared to the Sport group (p = 0.003-p < 0.001). 14% in the Sport-, 4% in the Cardio- and 83% in the Senior group achieved less than 9 points in the Application Score - which was considered insufficient. However, out of these 90% believed the application to be correct. CONCLUSIONS: The elderly cohort living in a retirement home demonstrated an impaired handling of the walker orthosis. Further, participants were incapable to self-assess the correct handling. These aspects should be respected when initiating treatment with a walker orthosis. TRIAL REGISTRATION: Retrospectively registered on the 16th of February 2018: # DRKS00013728 on DRKS.

Functional treatment for fractures to the base of the 5th metatarsal - influence of fracture location and fracture characteristics.

BACKGROUND: Fractures to the base of the fifth metatarsal are common, but their treatment remains controversial. Especially for Lawrence and Botte (L&B) type II fractures, there is conflicting evidence and consequently no consensus. Further, many authors consider displacement, articular involvement, and number of fragments an indication for surgery, although evidence is missing. The aim of this study was to evaluate the outcome of functional treatment for all L&B type I and II fractures. Of special interest were the influence of (1) the fracture location (L&B type I vs. II) and (2) the fracture characteristics (displacement, intra-articular involvement, communition) on the subjective outcome. METHODS: Retrospective registry study with a prospective follow-up. Patients with an acute, isolated, epi-metaphyseal fracture to the fifth metatarsal bone (L&B type I and II) treated by full weightbearing with a minimum follow-up of 6 months were included. Fracture location (L&B type I and II) and characteristics (displacement <2 mm or >2 mm, intra-articular involvement, and number of fragments) were assessed. Outcome parameters were return to work, return to sports, VAS-FA, and SF-12. The influence of the fracture (1) location and (2) -characteristics on these parameters was tested. RESULTS: Thirty-nine patients (40 ± 15 years, 56% female) were enrolled with a mean follow-up of 22 ± 10 months. L&B type I fractures occurred in 59%, type II in 41%. Thirty-one percent of all fractures were dislocated, 74% intra-articular, and 41% multi-fragmentary. Patients returned to work after 17 ± 12 days, to sports after 53 ± 22 days. The VAS-FA score at the final follow-up was 96 ± 4, SF-12 PCS score 57 ± 5 and MCS score 51 ± 8. No complications were reported, no patient required surgery. None of the assessed outcome parameters differed significantly between (1) the different fracture locations (L&B type I vs. II) or (2) the different fracture characteristics (displacement, intra-articular involvement, and number of fragments). CONCLUSIONS: (1) Both, L&B I and II fractures featured excellent results with immediate full weightbearing. Consequently, L&B type I and II fractures should be summarized as epi-metaphyseal fractures. (2) Fracture displacement, articular involvement, and number of fragments did not influence the outcome. Therefore, functional treatment should be recommended for all epi-metaphyseal fractures.

A systematic review of studies on the diagnostics and classification system used in surgically treated, acute, isolated, unstable syndesmotic injury: a plea for uniform definition of syndesmotic injuries.

Objective: To this day, diagnostic standards and uniform definition for acute, isolated syndesmotic injuries are missing. The aim of the current study was to conduct a systematic review of the classification systems and diagnostics currently applied and to propose a best evidence diagnostic approach. Methods: Medline (PubMed), Scopus, Cochrane Central Register of Controlled Trials, and Embase were searched from inception to June 5, 2022, for studies reporting the outcome of surgically treated acute, isolated syndesmotic injuries. First, all classifications used in the eligible studies were identified and illustrated according to the individual syndesmotic structures injured. Second, the indication for surgery and stabilization, based on the diagnostics applied and the time point assessed (pre- or intra-operatively), was analyzed, including the applied cutoff criteria. Results: Ten out of 4190 studies, comprising 317 acute ligamentous syndesmotic injuries, met the inclusion criteria. Seven studies facilitated one of the three different classification systems (Calder, West Point, or Sikka classification). Eight studies based their indication for surgery on a combination of clinical and radiographic examinations and two on radiographs only. The most applied clinical tests were the external rotation stress test and squeeze test. The most common radiologic diagnostics were plain radiographs and MRI. Intraoperatively, instability was verified most commonly using arthroscopy. Conclusion: Current classifications and diagnostics for syndesmotic injuries are heterogeneous, often cannot be attributed to the ligaments injured. An evidence-based diagnostic algorithm based on noninvasive diagnostics and an anatomy-based classification for acute syndesmotic instability is presented.

A 3-Ligament Syndesmotic Injury Is at Higher Risk for Malreduction Than a 2-Ligament Injury: A CT-Based Analysis.

BACKGROUND: Syndesmotic malreduction is common and has been associated to an impaired outcome. Various risk factors for DTFJ malreduction have been postulated. The aims of this study were to assess the DTFJ malreduction rate based on (1) the severity of the syndesmotic injury, (2) the anatomy of the tibial incisura, and (3) the fixation device used in patients treated with suture-button systems. METHODS: This retrospective, radiographic study included all adult patients who were treated for an acute, unilateral, and unstable syndesmotic injury with a suture-button system and postoperative bilateral CT imaging. Included were isolated syndesmotic injuries and fracture cases. The number of syndesmotic ligaments injured, that is, 2-ligament (AiTFL+IOL) and 3-ligament (AiTFL+IOL+PiTFL), was rated for each patient. The quality of DTFJ reduction, as well as the anatomy of the tibial incisura, was rated based on the postoperative, bilateral CT images and the intraoperative DTFJ reduction was recalculated based on the drilling-tunnel deviation. The possible influence on the DTFJ malreduction rate was assessed. RESULTS: A total of 147 patients were included, and 94 and 53 patients had a 2- and 3-ligament syndesmotic injury, respectively. In addition, 113 patients were treated with a single-button system, 26 with a double suture-button system, and 8 with a hybrid fixation (suture-button + screw). Malreduction was significantly higher in 3-ligament compared with 2-ligament injuries, both intraoperatively (51% vs 27%; P = .003) and postoperatively (28% vs 11%; P = .006). The tibial anatomy had no significant influence on the malreduction rates. No significant differences were seen per the different fixation devices used independent of the number of ligaments injured. CONCLUSION: This study did not find an influence of the incisura's anatomy on the DTFJ malreduction rate. However, we did find that 3-ligament syndesmotic injuries carried a higher risk of intra- and postoperative malreduction compared with 2-ligament injuries. LEVEL OF EVIDENCE: Level III, retrospective radiologic study.

Fracture pattern analysis of fractures to the diaphysis of the fifth metatarsal.

BACKGROUND: Fractures to the fifth's metatarsal (MT-V) diaphysis are common. These are inconsistently referred to as diaphyseal-, shaft-, or Dancer's fractures. A comprehensive analysis of the MT-V fracture morphology is missing. The aim was to qualitatively and quantitatively analyze fracture patterns of MT-V diaphyseal fractures. HYPOTHESIS: Fractures to the shaft of the fifth metatarsal feature specific fracture morphologies. MATERIALS AND METHODS: Retrospective, radiologic database study. Included were all acute, isolated MT-V shaft fractures (including the proximal [Lawrence and Botte (L&B) III] and distal meta-diaphysis). Demographics and fracture characteristics were assessed. Each proximal fracture line was drawn, scaled, and a qualitative and quantitative fracture line analysis was conducted. The quantitative fracture line analysis aimed at identifying dens clusters with arbitrary shape using the DBSCAN algorithm. Data are presented as mean±standard deviation. RESULTS: Out of 704 eligible MT-V fractures, 156 met the inclusion criteria. Patient's mean age was 46±19 years and 94% suffered a low energy trauma. Qualitative and quantitative fracture line analysis revealed three distinct fracture patterns. The proximal (30%) and distal (5%) meta-diaphyseal clusters showed a predominant transverse fracture pattern. The vast majority of diaphyseal fractures (56%) were spiral/oblique fractures, progressing from the proximal lateral meta-diaphyseal region in an oblique course at 61±9° to the medial distal diaphyseal cortex. Seven percent of diaphyseal fractures showed a transverse fracture pattern. DISCUSSION: Based on a qualitative and quantitative analysis of all MT-V shaft fractures, three distinct fracture clusters were identified with homogeneous fracture patterns. MT-V shaft fractures should therefore be classified as proximal meta-diaphyseal (L&B Type III), diaphyseal (oblique or transverse) and distal meta-diaphyseal. LEVEL OF PROOF: IV; retrospective database study.

Effects of medical interventions on health-related quality of life in chronic disease - systematic review and meta-analysis of the 19 most common diagnoses.

Introduction: The demographic shift leads to a tremendous increase in age-related diseases, which are often chronic. Therefore, a focus of chronic disease management should be set on the maintenance or even improvement of the patients' quality of life (QoL). One indicator to objectively measure QoL is the EQ-5D questionnaire, which was validated in a disease- and world region-specific manner. The aim of this study was to conduct a systematic literature review and meta-analysis on the QoL across the most frequent chronic diseases that utilized the EQ-5D and performed a disease-specific meta-analysis for treatment-dependent QoL improvement. Materials and methods: The most common chronic disease in Germany were identified by their ICD-10 codes, followed by a systematic literature review of these ICD-10 codes and the EQ-5D index values. Finally, out of 10,016 independently -screened studies by two persons, 538 studies were included in the systematic review and 216 studies in the meta-analysis, respectively. Results: We found significant medium to large effect sizes of treatment effects, i.e., effect size >0.5, in musculoskeletal conditions with the exception of fractures, for chronic depression and for stroke. The effect size did not differ significantly from zero for breast and lung cancer and were significantly negative for fractures. Conclusion: Our analysis showed a large variation between baseline and post-treatment scores on the EQ-5D health index, depending on the health condition. We found large gains in health-related quality of life mainly for interventions for musculoskeletal disease. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020150936, PROSPERO identifier CRD42020150936.

Study protocol: the effect of whole body vibration on acute unilateral unstable lateral ankle sprain- a biphasic randomized controlled trial.

BACKGROUND: Ankle sprains often result in ankle instability, which is most likely caused by damage to passive structures and neuromuscular impairment. Whole body vibration (WBV) is a neuromuscular training method improving those impaired neurologic parameters. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains. METHODS/DESIGN: 60 patients, aged 18-40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. Samples will be randomized by envelope drawing. All patients will be allowed early mobilization and pain-dependent weight bearing, limited functional immobilization by orthosis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical therapy will take place twice a week, for 30 minutes for a period of 6 weeks, following a standardized intervention protocol. During supervised physical therapy, the intervention group will perform exercises similar to those of the control group, on a side-alternating sinusoidal vibration platform. Two time-dependent primary outcome parameters will be assessed: short-term outcome after six weeks will be postural control quantified by the sway index; mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. Secondary outcome parameters include: return to pre-injury level of activities, residual pain, recurrence, objective instability, energy/coordination, Foot and Ankle Disability Index and EQ 5D. DISCUSSION: This is the first trial investigating the effects of WBV in patients with acute soft tissue injury. Inversion ankle sprains often result in ankle instability, which is most likely due to damage of neurological structures. Due to its unique, frequency dependent, influence on various neuromuscular parameters, WBV is a promising treatment method for patients with acute unstable inversion ankle sprains. TRIAL REGISTRATION: NCT01702597.