Bunion

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 the effectiveness of multiple human placental membrane products, called CAMPs, combined with Standard of Care (SOC) versus SOC alone in treating nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). This multicenter, prospective, randomized controlled trial uses a modified platform design to compare different CAMP products, including AM/Single and AM/Double, in promoting ulcer closure over 12 weeks. Participants will receive weekly treatments depending on their assigned group. The Standard of Care involves cleaning, debridement, moisture balance, and offloading or compression as appropriate. Those in CAMP groups will receive weekly applications of either AM/Single (a single layer human amniotic membrane allograft) or AM/Double (a double layer allograft) in addition to Standard of Care. Treatment continues until the ulcer closes or up to 12 weeks. During the study, participants will attend weekly visits for treatment and evaluation. Researchers will assess ulcer closure rates, time to closure, percent area reduction, pain changes, adverse events, and quality of life improvements over 12 weeks. The study monitors participants closely to measure healing progress and safety of the treatments throughout the trial duration.

Researchers are comparing two methods of minimal invasive surgery to treat severe Hallux Valgus, a condition affecting the big toe causing pain and deformity. This randomized controlled trial evaluates the outcomes of using either one or two Kirshner wires for fixation during distal linear metatarsal osteotomy. The study aims to understand if adding a second wire improves stability, reduces complications like recurrence and infections, and enhances pain relief and function. Participants are divided into two groups of 25 each. One group receives the standard fixation with one Kirshner wire placed through the first metatarsal bone, while the other group has an additional wire inserted across the metatarsophalangeal joint for extra stability. This second-generation minimal invasive surgery is chosen for its cost-effectiveness, less pain, smaller scars, shorter surgery time, and reduced blood loss. Over a follow-up period of one year, participants will attend regular visits to complete questionnaires and undergo radiographic exams to measure the Hallux Valgus Angle at baseline and multiple time points up to 12 months. Researchers will analyze pain, function, and complications to compare the two fixation methods. The study involves detailed monitoring to assess the effectiveness and safety of the surgical techniques.

Researchers are studying the effects of virtual reality-based interventions on foot function, foot pressure, and balance in sedentary individuals. The study aims to compare how different virtual reality and traditional exercise programs impact these aspects to better understand rehabilitation approaches for foot-related conditions. Participants are randomly assigned to one of three groups. One group uses a virtual reality-supported rehabilitation program integrated with the Biodex Balance System device for interactive balance and postural stability exercises. Another group performs balance and foot exercises using videos with visual guidance to simulate a virtual reality experience. The control group follows a traditional home exercise program without virtual reality involvement. During the 6-week study, participants will have their foot function, maximum plantar pressure, contact area, center of pressure, balance performance, and physical activity levels assessed. These evaluations will help measure changes and improvements due to the different exercise programs. The study involves regular monitoring to track progress and outcomes related to foot health and balance.

This research aims to evaluate three commonly used medications added to a local anesthetic during a popliteal sciatic nerve block in children aged 3 to 12 years undergoing surgery on the lower leg or foot. The study compares dexamethasone, dexmedetomidine, and their combination to see if the combination provides longer pain relief and reduces the need for additional pain medication after surgery. It is a randomized, double-blinded, controlled clinical trial focused on improving postoperative comfort in pediatric patients. All children will receive a single injection of 0.2% ropivacaine for the nerve block under ultrasound guidance. Participants will be randomly assigned to one of three groups: ropivacaine with dexamethasone, ropivacaine with dexmedetomidine, or ropivacaine with both dexamethasone and dexmedetomidine. The nerve block will be performed using a 22-gauge echogenic needle under sterile conditions before surgery, and all children will receive standard perioperative pain control. During the study, trained observers who do not know the group assignments will assess pain scores, block duration, opioid use, and recovery. Follow-up calls will occur one week and one month after surgery to check for nerve injury or other effects. The main outcome measured is the time until the first need for additional pain relief within 24 hours after surgery. Secondary measurements include opioid use, behavioral pain scores using FLACC at various times after surgery, adverse events, and early recovery of function.

Researchers are evaluating the effects of selective strengthening of the peroneus longus muscle compared to a conventional physical therapy program for people with mild to moderate hallux valgus, a foot condition causing pain and limited function. The study aims to measure changes in the hallux valgus angle, pain levels, and foot function to better understand which approach may help improve these symptoms. Participants will be randomly assigned to one of two groups. Group A will perform weight-bearing exercises targeting the peroneus longus muscle along with conventional physical therapy. Group B will follow a program consisting of three commonly used exercises for hallux valgus, including passive abduction of the hallux, short foot exercises, and toe spread outs. The study lasts six weeks, with assessments at the start and end of this period. Throughout the study, participants will have their hallux valgus angle measured using specialized software, and their pain and foot function will be evaluated using standard scales. These assessments occur at baseline and after six weeks of treatment. The study also uses double-blind methods to reduce bias. Participants can expect regular evaluations and monitoring during their involvement, which lasts about six weeks in total.

Hallux valgus, commonly called a bunion, is a condition where the big toe bends toward the other toes, often causing pain and difficulty wearing shoes. Surgical correction realigns the toe, but during recovery, a toe spacer is used to keep the toes properly positioned while soft tissues heal. This study evaluates whether a new custom-made 3D-printed toe spacer is better tolerated and helps maintain toe alignment compared to the standard folded-gauze spacer after bunion surgery. The trial includes 40 adults undergoing hallux valgus surgery, randomly assigned to receive either the 3D-printed spacer or the standard gauze spacer. The custom spacer is made individually for each patient using 3D printing technology and thermoplastic polyurethane, a biocompatible material used in orthopedic devices. It is placed externally between the big toe and second toe immediately after surgery and worn continuously for five weeks as part of routine postoperative care. The standard group receives the usual folded gauze spacer, also worn continuously for five weeks. Both spacers are non-invasive and applied immediately after surgery. Participants will have follow-up visits at 1 week, 3 weeks, and 5 weeks after surgery to assess comfort, pain, and any skin irritation from the spacer. At the final visit, toe alignment will be checked using routine weight-bearing X-rays and clinical examination. No extra medical procedures or radiation beyond standard care are needed. The main goal is to see if the 3D-printed spacer is better tolerated, with secondary goals assessing toe alignment and spacer-related side effects during this five-week period.

Researchers are evaluating clinical and radiological factors that may predict outcomes after surgery for hallux valgus (HV), a common adult forefoot deformity. The study focuses on understanding the deformity in three dimensions using new radiological parameters, aiming to improve insight into why current surgical techniques often have variable results and high recurrence rates. This prospective observational study seeks to address the lack of clear treatment guidelines and consensus for surgical intervention in HV. Participants accepted for corrective surgery for hallux valgus at Ostfold Hospital Trust will be invited to join the study. The study compares preoperative clinical data, patient-reported outcome measures (PROMs), and radiological parameters with postoperative assessments. Participants will be evaluated using the Manchester-Oxford Foot Questionnaire and radiological imaging before surgery and at 6 weeks, 12 weeks, and 52 weeks after surgery. During the study, participants will complete questionnaires and undergo radiological exams at specified intervals to track changes in foot function and deformity correction. The main outcome is comparing pre- and postoperative MOXFQ scores to assess patient-reported outcomes. Secondary measures include comparing traditional and newer rotational radiological parameters with PROMs. The study aims to include 200-250 participants and will monitor them for up to one year post-surgery.

Researchers are studying the effect of adding a lateral soft tissue release (LSTR) during Chevron osteotomy bunion surgery in adults over 18 years old with mild to moderate bunions. The study aims to find out if this addition improves correction of the hallux valgus alpha angle (HVA) and intermetatarsal angle (IMA) without causing extra complications. Two hundred patients will participate, and the trial is sponsored by The Methodist Hospital Research Institute. Participants will be randomly assigned to one of two groups: one will receive the standard Chevron osteotomy bunion surgery, and the other will have the same surgery plus a lateral soft tissue release. The study will compare outcomes between these two approaches. Surveys will be completed before surgery and at 3, 6, and 12 months after surgery to assess patient-reported results. During the study, routine X-rays will be taken before and after surgery to measure the hallux valgus angle and intermetatarsal angle corrections. Researchers will also monitor for recurrence of the bunion deformity and any complications at 3, 6, and 12 months after surgery. The main outcome measured is the correction of the hallux valgus alpha angle six weeks after surgery. Participation will last up to one year with regular follow-up visits.

Researchers are evaluating the outcomes of combining the Adductoplasty12 and Lapiplastyae Procedures for patients who need surgery to correct metatarsus adductus and hallux valgus. This study aims to assess how well these procedures improve quality of life and reduce pain, as well as to determine if they effectively correct and maintain the alignment of the first three metatarsals, hallux position, sesamoid position, and foot width. The trial is a prospective, multicenter, unblinded study involving up to 80 participants aged 14 years and older with symptomatic conditions. Participants will undergo the combined Adductoplasty12 and Lapiplastyae Procedures, which involve surgical correction of foot deformities. The study duration extends up to five years following the initial surgery. There are no comparator groups mentioned as this is a single arm intervention study conducted across multiple clinical sites. The procedures are performed under general anesthesia, and patients must be able to adhere to postoperative care instructions. During the study, participants will be assessed at various intervals up to 60 months after the procedure. Evaluations include radiographic imaging to check for recurrence of deformities, measurement of pain and quality of life changes, range of motion, foot width, and monitoring of clinical complications. Weight-bearing recovery times and return to unrestricted activity will also be tracked. These outcomes will help researchers understand the effectiveness and durability of the combined surgical approach.