Bunion

Researchers are evaluating the surgeon experience and surgery outcomes in participants undergoing the index Lapidus procedure to correct hallux valgus, a foot deformity where the big toe angles outward causing a painful bump. The study assesses the use of the VIRTUGUIDE System along with compatible DePuy Synthes Lapidus implants. This observational study aims to gather detailed information on surgical results and patient health following this specific procedure. Participants will undergo the primary Lapidus procedure using the VIRTUGUIDE System software and instruments and receive compatible DePuy Synthes Lapidus implants. All participants will be followed according to the surgeons standard care for up to 12 months after surgery. The study does not involve additional interventions beyond routine clinical care. During the study, participants will be monitored for up to 12 months post-procedure. Assessments include radiographic documentation of bone fusion and healing, patient-reported outcome measures such as quality of life and pain scores, and tracking of any adverse events related to the device or procedure. Researchers will also record any revisions, reoperations, or recurrences. The study collects data on participants recovery and safety throughout this 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 WeilHohmann 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 AMSingle and AMDouble, 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 AMSingle a single layer human amniotic membrane allograft or AMDouble 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.

Hallux valgus is a common deformity of the forefoot that mainly affects women and requires surgical correction involving osteotomy of the first metatarsal and sometimes the first phalanx of the big toe. The study aims to evaluate whether adding self-rehabilitation through a connected application alongside traditional physiotherapy improves postoperative joint mobility compared to standard physiotherapy care alone. The trial focuses on patients undergoing isolated hallux valgus surgery with the goal of enhancing foot function and mobility. Participants undergo hallux valgus surgery followed by two different rehabilitation approaches one group uses a connected application to perform exercises at home in addition to physiotherapy sessions twice weekly for 10 weeks, while the other group receives only the standard physiotherapy care. The connected application is designed to reproduce continuous passive range of motion exercises outside of scheduled physiotherapy visits to improve foot mobility. During the 6-month study period, participants will have their metatarsophalangeal joint mobility assessed as the primary outcome. They will complete questionnaires such as EFAS, EVA, and EQ-5DL to monitor progress. The study evaluates whether self-rehabilitation using the app combined with physiotherapy leads to better mobility outcomes than physiotherapy alone, with assessments conducted at regular intervals throughout the recovery process.

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.