Foot Deformity

Researchers are studying ankle and hindfoot conditions caused by biomechanical changes in this area. The trial focuses on how surgical treatments aimed at improving these biomechanical problems may relate to clinical improvements. A special 3D Multisegment Foot Model has been developed and validated to assess these biomechanical changes more precisely, and it is now used routinely at the gaitlab of UZ Leuven. The study evaluates patients who have undergone ankle or hindfoot reconstruction surgery. It uses advanced biomechanical assessments combining plantar pressure measurements and detailed 3D gait analysis with the Multisegment Foot Model. This integrated approach allows researchers to examine many biomechanical parameters within the foot and ankle region before surgery and one year after surgery. Participants will have assessments before their surgery and at multiple follow-up points including 6 months and 1 year after surgery. These assessments include gaitlab measurements, foot function questionnaires, health surveys, and pain scales. The study aims to link clinical outcomes with detailed biomechanical data, helping to better understand the effects of reconstructive surgery on foot and ankle function over time.

Researchers are evaluating the safety and performance of MagnetOs Putty and MagnetOs Easypack Putty, compared to autogenous bone graft, in patients undergoing hindfoot or ankle fusion surgeries. This phase IV post-marketing study focuses on treating hindfoot and ankle disorders, where synthetic bone graft extenders like MagnetOs products are routinely used by surgeons. The trial aims to assess bone fusion and functional outcomes in patients receiving these treatments. Patients will be randomly assigned to receive either MagnetOs Putty/Easypack Putty or a local autograft harvested from the calcaneus, distal tibia, or proximal tibia. Both treatments will be used with rigid hardware fixation during fusion surgeries such as ankle fusion, subtalar fusion, calcaneocuboid fusion, talonavicular fusion, or double fusion involving any two of these joints. The volume of MagnetOs or autograft used varies by joint, typically 1-5 cc for certain joints and up to 10 cc for the tibiotalar joint. Participants will be followed after surgery with visits at discharge and weeks 2, 6, 12, 24, and 52. Imaging evaluations, including radiographs and CT scans, will be performed at multiple time points to assess bone fusion and healing. The main outcome will be bone fusion measured by CT scan at 24 weeks post-operation. Additional assessments will include functional evaluations and further imaging up to one year post-surgery. Weight-bearing radiographs will begin at week 12, and safety monitoring will continue throughout the study period.

Researchers are evaluating post-operative management approaches after a modified Lapidus arthrodesis surgery for hallux valgus, with or without additional surgeries such as Akin or Weil/Hohmann procedures. The study aims to compare the effectiveness and safety of immediate full weight-bearing versus partial weight-bearing (10-15 kg) during rehabilitation. This randomized controlled trial explores a new rehabilitation method following foot surgery to improve recovery. Participants will be randomly assigned to one of two groups after surgery: one group will follow partial weight-bearing with a specialized VACOPASO shoe and use crutches along with antithrombotic medication for 6 weeks, while the other group will have immediate complete weight-bearing with the same shoe and medication for the same period. The surgical operation follows standard clinical practices for hallux valgus correction. During the study, healing progress will be monitored through standard X-rays at 6, 12, and 24 weeks to check bone healing, hardware fixation, and fracture alignment. Pain will be measured using a Visual Analogue Scale at the day of surgery and at follow-up visits. Quality of life and functional recovery will be assessed through established foot and ankle scoring systems at multiple time points. The main outcome is the subjective functional recovery measured by the Olerud and Molander Ankle Score at 6 weeks post-surgery.

Researchers are evaluating advanced surgical simulation techniques for correcting complex skeletal deformities and abnormalities in children, adolescents, and young adults with musculoskeletal disorders. These conditions often involve rare and severe abnormalities in bone, joint, and muscle-tendon development, affecting multiple limbs and presenting challenges in standardizing treatment and predicting outcomes. The study focuses on improving surgical planning and support tools using 3D modeling and printing technologies, aiming to enhance precision, safety, and reproducibility of surgeries. The study involves surgeries to correct bone deformities, supported by preoperative virtual surgical planning and the use of patient-specific instruments created through 3D printing. These include Patient-Specific Instruments (PSI) and Graft-Specific Instruments (GSI), which are designed to improve surgical accuracy. The research is conducted within specialized 3D laboratories at the Musculoskeletal Apparatus Network centers, where surgical simulations and planning procedures are systematically organized and standardized. Participants will undergo assessments including radiological follow-up and clinical-functional evaluations at the time of surgery and after one year. Researchers will measure outcomes such as the degree of skeletal correction achieved, operating room times, fluoroscopy times, blood loss, and any intra- or peri-operative complications. The suitability of the patient-specific instruments and bone grafts will also be evaluated. The study aims to improve surgical quality and efficiency while monitoring participants throughout a one-year period post-surgery.

Researchers are studying adults with lower-limb impairment following a stroke to find the best ankle-foot orthosis (AFO) design that can improve their health-related quality of life. This clinical trial aims to compare three different modern carbon fiber AFO options and understand how they impact walking and balance. The study will also develop prediction models based on biomechanical function linked to each AFO design to guide clinical prescriptions. Participants will try three different AFO designs in a randomized order, wearing each device for one month after receiving training. The three types of AFOs include a pre-fabricated (PF) device customized to the patient, a carbon-strut (CS) AFO molded to the affected limb, and a multifunctional articulating (MA) AFO with controlled ankle movement. Each participant will follow one of six sequences where they wear each AFO for four weeks, covering all three devices. During the study, participants will complete questionnaires and performance tests with each AFO. A subset will also undergo biomechanical analyses using high-speed cameras and force plates while walking and balancing with each device. Researchers will measure health-related quality of life over the four-week real-world use of each AFO. The study is expected to last until October 2027, with ongoing assessments to understand the impact of each AFO on function and quality of life.

Researchers are evaluating surgical treatment called arthrorisis of the subastragalus joint using a polymeric implant to address flexible flatfoot in children aged 8 to 14 years. This condition involves joint deformity causing flat feet, and the study aims to analyze clinical and radiographic outcomes over time during growth. The trial is a prospective observational study involving 55 patients to better understand the treatment's effects. The surgical procedure uses a polymeric endorthesis designed to restore proper alignment between the astragalus and calcaneus bones and maintain this correction over time. The goal is to allow natural bone remodeling along growth lines, usually within a few years. This study tracks patients undergoing this specific surgery without comparing other treatments. Participants will be monitored regularly with measurements of Meary's angle at baseline and multiple follow-up points up to 72 months after surgery. Additionally, the American Orthopaedic Foot & Ankle Society (AOFAS) scores will be assessed at the same intervals. These evaluations help assess the joint alignment and foot function over time. The study will continue collecting data and monitoring outcomes until 2028.

Researchers are evaluating the effects of biofeedback-assisted short foot exercises compared to traditional short foot exercises in adults with flexible pes planus, also known as flexible flatfoot. The study aims to find out if adding biofeedback to exercises improves foot biomechanics, balance, and functional ability more than exercises alone. The research will focus on changes in plantar pressure distribution, foot posture, balance, ankle range of motion, and overall foot function. Participants will be randomly assigned to one of two groups: one group will perform biofeedback-assisted short foot exercises, while the other group will do traditional short foot exercises without biofeedback. Both groups will participate in supervised exercise sessions twice a week for six weeks. The study uses a randomized design with single masking to compare the two exercise approaches. During the study, participants will undergo assessments before and after the six-week exercise program. These evaluations include plantar pressure analysis, balance tests such as the Y-Balance Test, foot posture measurements like the Foot Posture Index-6, ankle range of motion tests, and self-reported questionnaires on foot and ankle ability. Researchers will monitor improvements in function and biomechanics to determine which exercise method offers greater benefits.

This research aims to evaluate the effectiveness of a specially designed thermoplastic thumb orthosis compared with factory-made fabric orthoses in women with rheumatoid arthritis and boutonniere deformity of the thumb. The study will assess how these devices impact hand function, strength, dexterity, and pain levels over time. About 60 female participants aged 18 to 65 years will be included, with half using the thermoplastic orthosis and half using the factory-made version. Participants will be randomly assigned to wear either the thermoplastic or fabric orthosis. The thermoplastic device is designed to correct the alignment of the thumb joints by properly tensioning the extensor bands, aiming to improve hand mobility, grip strength, and reduce pain. Both groups will be monitored for changes in grip strength, pincer grip strength, pain levels, hand function, and satisfaction with the orthosis over a six-month period. During the study, participants will undergo regular measurements of grip and pincer strength using a hydraulic handgrip dynamometer, complete the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire to assess upper limb disability, rate their pain on a numerical scale, and evaluate thumb opposition using the Kapandji score. Satisfaction with the orthosis will also be assessed using a Likert scale. Researchers will compare the results between the two groups to determine which orthosis offers better function and pain relief.

Researchers are comparing two local anesthetic methods for ultrasound-guided popliteal sciatic nerve block in adults aged 18 to 65 undergoing elective distal lower leg surgery. This study focuses on how quickly sensory and motor blockades begin and evaluates several postoperative outcomes such as pain levels, opioid use, and recovery quality. The trial is conducted at Ataturk University Research Hospital in Turkey with 60 participants divided into two groups. Participants will receive one of two treatments before surgery: one group gets a combination of lidocaine and bupivacaine, while the other group receives bupivacaine alone. Both treatments involve 20 mL total volume administered via ultrasound guidance to the popliteal sciatic nerve. Some patients may also receive an additional adductor canal block. During surgery, sedation and vital signs are carefully monitored, and standardized postoperative pain relief is provided. Throughout the study, researchers will assess block onset time, success rates, duration of sensory and motor block, and pain scores at multiple time points up to 24 hours after surgery. They will also monitor opioid use, quality of recovery, and any rebound pain. Neurological assessments are performed one week after surgery to check for any nerve issues. The study uses a double-blind design, with patients and outcome assessors unaware of the treatment group.

This study aims to collect prospective safety and effectiveness data for the C-Brace System, a microprocessor-controlled knee ankle foot orthosis, following standard care practices. The research focuses on patients with lower extremity pareses who are fitted with the C-Brace device. The goal is to better understand how the C-Brace influences walking speed, balance, risk of falling, and confidence in balance over time. The C-Brace is a custom-made device with thigh, calf, and foot components connected by an ankle joint or spring element. It uses sensors to continuously monitor knee joint movement and walking phases, adjusting hydraulic resistance and knee motion accordingly. Patients enrolled in the registry will undergo baseline evaluation, fitting, training or therapy sessions, and follow-up visits at 6, 12, 24, and 36 months after fitting. Participants will be assessed through various tests including timed walk tests, balance confidence scores, and mobility assessments at different intervals. The study also tracks falls related to device use and changes in activity levels with an activity tracker. Data collected will help characterize the safety and functional impact of the C-Brace over three years of follow-up.