Clinical Research Directory

Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation

The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The study recruits 125 adult patients who meet the acceptance criteria. The follow-up time for each study patient is 4 years. The study is a single center single group study which is conducted in Tampere University Hospital (TAYS) in Finland. The main focus of the study in terms of performance is to evaluate the bone healing/ossification of operated areas. The main focus of the study in terms of safety is to evaluate the occurrence of adverse events and required revision surgeries that are or might be related to the study device.

Randomized Controlled Trial of Custom Foot Orthoses for Chronic Forefoot Pain

Background Chronic metatarsalgia (CM) causes significant pain and disability, affecting quality of life. Foot orthoses (FOs) including medially wedged designs with a metatarsal pad decrease excessive plantar pressure under the metatarsal heads, which is a suggested risk factor for developing CM. This FOs model may be effective in diminishing pain and improving function in these individuals. Thus, the objective of this trial will be to compare the effects of medially wedged FOs with a metatarsal pad and sham FOs on pain and foot function in individuals with CM. Methods/design This participant- and assessor-blinded superiority randomized controlled trial (RCT) with two parallel groups will be conducted in Trois-Rivières, Canada. Sixty-four participants with CM will be recruited from the Université du Québec à Trois-Rivières outpatient podiatry clinic and via social media invitations. They will be randomized into intervention (customized FOs) or control (sham FOs) groups and will be evaluated at baseline and after 6 and 12 weeks. The primary outcome will be: (1) mean pain during walking for the most painful foot during the past week. The secondary outcomes will be: (1) Foot Function Index, (2) Global rating of change and (3) the 5-level EQ-5D. Discussion Medially wedged FOs with a metatarsal pad are expected to provide a greater reduction in pain and improvement in foot function compared to sham FOs. This trial will help guide FOs prescription recommendations for managing foot pain in individuals with CM in the future.

Baropodometric Patterns Associated with Metatarsalgia

The therapeutic plan for certain pathologies in the adult population typically includes the performance of moderate physical activity aimed at preventing cardiovascular risk due to sedentary lifestyle, improving muscle tone and balance to prevent falls, enhancing bone health, and maintaining proper functional and mental health state. However, this activity can be hindered by pain arising from musculoskeletal injuries of low or moderate significance. One such injury is metatarsalgia, characterized by acute or chronic pain in the plantar area of the forefoot due to an overload of plantar pressure. It affects one or several central metatarsals and their respective metatarsophalangeal joints. Metatarsalgia is a highly prevalent pathology (up to 83%) in patients aged 60 or older and negatively impacts their quality of life. To alleviate plantar pressure in the affected area, metatarsal offloading devices are commonly used, which can now be integrated into socks or stockings. This integration aids in pain reduction through an everyday, easy-to-use item. However, only preliminary results of their effectiveness exist, and are in a standard model without customization for the patient's foot. Therefore, the goal is to identify different plantar pressure patterns in a sample of female patients over 55 years with metatarsalgia and design personalized three-dimensional plantar elements that can be integrated into the sock's structure to reduce over pressure and improve the clinical picture. A prior evaluation of pain (Foot Pain and Disability Index), impact on quality of life (SF-12 questionnaire), assessment of physical activity (IPAQ), and baropodometric evaluation with instrumented Pedar® insoles (Novel, Germany) will be conducted. This will characterize the patterns of plantar pain. Using 3D scanning of the foot, a personalized three-dimensional element for each plantar pain pattern will be designed to relieve this excess load, and will be integrated into the body of the sock through weaving, thermofusion, or thermosealing. This sample of patients with metatarsalgia will be randomly divided into three groups, who for a period of six months will wear the offloading sock model, personalized plantar supports with selective offloading, or a stabilizing element for the affected metatarsal head that the patient can apply and remove themselves. After these six months, plantar pain, quality of life, and physical activity levels will be re-evaluated in the three groups to determine the potential efficacy of the experimental sock compared to the best possible treatment, insoles, and another common element such as alignment devices. The offloading sock would provide a personalized solution for each patient, requiring no adaptation or frequent replacement, thus creating better adherence to treatment. The number of effective treatment usage hours would increase since socks are part of the patients' regular attire. Additionally, associated costs would be reduced, as there would be no need for frequent replacement of removable pads, stabilizing devices, or regular revisions to adjust orthopedic insoles.