Bunion

Explore bunion research studies for new treatment options. All trials listed comply with HIPAA and IRB protocols.

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Found 27 Actively Recruiting clinical trials

A

RECRUITING

Healthy Volunteer

The surgical operation will be carried out according to the standard clinical practice, namely following the modified Lapidus general and specific rules concerning the surgical treatment of hallux valgus with/without an Akin or a Weil/Hohmann surgery fusion. Post-operatively, patients who meet the eligibility criteria will be randomized into one of the two groups (partial weight-bearing limited at 15kg vs full weight-bearing) Patient in both groups will be wearing a VACOPASO shoe for 6 weeks. Standard X-ray assessment to determine healing, hardware fixation, fracture alignment, fracture reduction, implants mobilization will be performed at weeks 6, 12, 24. Change in pain severity from the day of surgery to 6, 12 and 24 weeks postoperatively will be measured using the pain Visual Analogue Scale (VAS). Quality of life will be assessed through the American Orthopedic Foot and Ankle Score (AOFAS). Subjective functional recovery through the Olerud and Molander Ankle Score (OMAS).

18-85 yearsAll GendersNA
1 location
C

RECRUITING

The C5CAMP trial is a multicenter, prospective, randomized controlled clinical trial to evaluate subjects that meet medical necessity criteria for cellular, acellular, and matrix-like products (CAMPs). The study utilizes a prospective modified platform design to evaluate two separate CAMPs, AM/Single and AM/Double in a single trial. The initial plan is to evaluate two CAMPs; however, the modified platform design permits the inclusion of additional CAMPs. This study will evaluate the clinical utility of multiple CAMPs in the closure of diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.

18+ yearsAll GendersNA
1 location
C

RECRUITING

This is a randomise controlled trial between two groups patients, which are assigned to two different interventions, undergoing minimal invasive Hallux valgus surgery. 2nd generation of Minimal invasive surgery was selected in hallux valgus surgery due to its availability, cost effectiveness, reduced pain , and the overall simplicity of the operation, providing smaller surgical scars, and less op time , as well as blood loss. this was done by making a osteotomy cut at the first metatarsal neck and placing one intramedullary Kirshner wire through the first metatarsal joint. However the stability and the complication of this technique still remains - such as recurrence, K wire loosening, pin tract infection and malunion. We believe that by adding another intramedullary Kirshner wire to fix the first metatarsal accoss the Metatarsophalangeal joint, the stability of the construct will improve and maintain a reduced hallux valgus angle ,and reduce the rate of complications , ultimately improving pain and functional outcome of the patient. the participants were purposely randomized, and divided into two equal groups with 25 cases. the control group recieved a fixation with one Kirshner wire (standard) and the experimental group recieved a fixation with two Kirshner wire. Data were analyzed using paired T test , wilcoxon signed-rank test and chi squared test

18-60 yearsAll GendersNA
1 location
C

RECRUITING

Healthy Volunteer

Comparison of the Effects of Virtual Reality-Based Interventions on Foot Function, Foot Pressure, and Balance in Sedentary Individuals

18-45 yearsAll GendersNA
1 location
D

RECRUITING

Popliteal sciatic nerve block is frequently used in pediatric anesthesia to provide effective pain control for surgical procedures involving the lower leg, ankle, and foot. Although ropivacaine alone offers good analgesia, its duration is limited, and additional medications (adjuvants) are often added to prolong the effect of the block. Two commonly used adjuvants are dexamethasone, a corticosteroid, and dexmedetomidine, an alpha-2 adrenergic agonist. Each of these medications has been shown to extend the duration of analgesia, but it remains unclear whether combining them provides an additive or potentially synergistic benefit. This randomized, double-blinded, controlled clinical trial will compare three perineural adjuvant strategies: dexamethasone, dexmedetomidine, and their combination. All participants will receive a single-shot popliteal sciatic nerve block with 0.2% ropivacaine. Children will then be randomized into one of three treatment arms: 1. ropivacaine with perineural dexamethasone, 2. ropivacaine with perineural dexmedetomidine, or 3. ropivacaine with a perineural combination of dexamethasone and dexmedetomidine. Pain scores, block duration, opioid use, and recovery parameters will be assessed by trained observers who are blinded to group assignment. The primary aim is to determine whether the combination of dexamethasone and dexmedetomidine leads to superior analgesia compared with either drug alone. Secondary aims include evaluating the time to first rescue analgesia, total postoperative opioid requirements, behavioral pain scores (e.g., FLACC), adverse events, and early functional recovery. This study seeks to provide high-quality evidence to guide the optimal choice of perineural adjuvants in pediatric regional anesthesia and may help establish best-practice recommendations for improving postoperative comfort and safety in children undergoing lower-limb surgery.

3-12 yearsAll GendersNA
1 location
E

RECRUITING

Purpose of this study is to measure Change in Hallux valgus angle (HVA )as measured by kinovea software Change in pain as measured by numerical pain rating scale (NPRS) Change in function as measured by Foot function index (FFI )Egyptian version With the peroneus longus strengthening exercise versus the use of conventional physical therapy programme in cases of hallux valgus patients

18-60 yearsAll GendersNA
1 location
E

RECRUITING

Hallux valgus is a common forefoot deformity characterized by lateral deviation of the hallux and medial deviation of the first metatarsal. Surgical correction is performed to restore alignment and relieve symptoms, but postoperative soft tissue healing requires mechanical support to maintain the correction during early recovery. A toe spacer is routinely used for this purpose, generally applied between the hallux and second toe for several weeks after surgery. Traditional spacers, typically fabricated from folded gauze, are non-custom solutions that may not conform to the patient's individual anatomy. As a result, they may cause discomfort, pressure areas, or misalignment of the lesser toes. To overcome these limitations, a custom-made spacer has been designed using 3D-printing technology. The device is manufactured from thermoplastic polyurethane (TPU), a biocompatible material commonly used in orthotic applications. It is externally applied and does not enter the surgical wound. The device is intended to improve comfort and maintain postoperative hallux alignment more effectively than standard spacers. This study is a single-center randomized controlled trial evaluating the feasibility, tolerance, and early alignment outcomes associated with the use of the custom-made 3D-printed spacer compared to standard folded-gauze spacers. Forty adult participants undergoing hallux valgus surgical correction will be randomly allocated in a 1:1 ratio to the intervention or control group through sealed opaque envelopes prepared prior to study initiation. Both interventions are non-invasive and part of routine postoperative care. The spacer will be applied immediately after surgery and continuously maintained for five weeks. Standardized follow-up evaluations will be performed at 1, 3, and 5 weeks after surgery. Tolerance of the device will be assessed using patient-reported comfort and pain scores and clinical evaluation of skin condition, including the presence of irritation, redness, pressure marks, or ulceration. Alignment outcomes will be assessed at the final follow-up visit using routine weight-bearing radiographs and clinical examination. The primary aim of this investigation is to assess the tolerance of the custom-made 3D-printed postoperative spacer. Secondary aims include the evaluation of hallux and lesser-toe alignment at five weeks and the documentation of spacer-related adverse events. Because this is an early clinical assessment of a new supportive postoperative device, the study is designed as a minimal-risk feasibility trial with a pragmatic sample size. All surgical procedures and postoperative care will be conducted by fellowship-trained foot and ankle surgeons using standardized techniques. To minimize bias, allocation concealment is ensured by the envelope randomization method, follow-up timing is standardized, and imaging evaluation will be performed based on prespecified measurement criteria. No additional imaging, radiation exposure, or medical procedures are required beyond standard postoperative care, and participation does not alter the surgical treatment plan. The study is classified under Risk Category A according to the Swiss Human Research Ordinance (HRO), as the device does not pose significant additional risks or burdens beyond normal clinical practice. The findings of this study will provide preliminary evidence on the clinical feasibility and patient acceptance of customized postoperative spacers following hallux valgus surgery. Positive results may support future larger-scale trials designed to assess long-term clinical outcomes and validate the benefits of individualized postoperative support in forefoot surgical care.

18+ yearsAll GendersNA
1 location
H

RECRUITING

Hallux valgus (HV) is the most common deformity in the adult forefoot. Characterizing and classifying HV primarily has been based on weightbearing radiographic imaging. Understanding of this pathologic process has mainly been confined to two planes, where the dominating modality of choice has been assessment by antero-posterior (AP) and lateral radiographs. From these two projections, imaging parameters have developed to define the severity of HV. With this understanding as the basis for describing the deformity, more than 140 operative techniques have been described. Although many of these techniques are of historical interest only, consistently favourable outcomes remain elusive even among more popular current techniques. HV corrective surgery is known to have mediocre results, with recurrence rate as high as 30-70%. Unsuccessful treatment of the condition is amongst the most common in the Norwegian patient injury compensation scheme. The variation in corrective techniques and the associated persistent and clinically significant rates of poor outcomes may indicate an incomplete treatment of the pathoanatomy of HV. Numerous recent publications have proved that the hallux valgus deformity should be viewed as a three-dimensional deformity. These recent studies have also pointed out new radiological parameters in AP and axial view, focusing on the multiplanar understanding of the deformity. The key challenge of the hallux valgus foot is the lack of clear guidelines for choosing the best treatment to these large group of patients. There is of today no guidelines nor consensus considering the indication for surgical treatment of the hallux valgus deformity. It is not known how much nuisance the patient should present before surgery could be worthwhile. Many studies have been made in the field of HV, but literature with the focus on comparing the surgical correction and the patient related clinical outcome is sparse and insufficient. In this project the investigators primary aim is to investigate radiological and clinical factors that predict outcome in participants operated for hallux valgus deformity.

18+ yearsAll Genders
1 location
L

RECRUITING

The goal of this clinical trial is to determine if performing a lateral soft tissue release during a Chevron osteotomy (or Akin osteotomy when appropriate) for bunions leads to better correction without added complications in 200 patients over the age of 18 years old with the capacity to consent and mild to moderate bunions that are determined to benefit from Chevron osteotomies by one of the IRB approved study physicians. The main questions it aims to answer are: How does the addition of a lateral soft tissue release (LSTR) in a Chevron osteotomy bunion surgery affect hallux valgus alpha angle (HVA) correction? How does the addition of an LSTR in a Chevron osteotomy bunion surgery affect intermetatarsal angle (IMA) degrees of correction? Researchers will compare Chevron osteotomy bunion surgeries with and without LSTR to see if LSTRs lead to better correction without added complications. Participants will: * Be randomized to a control group where they receive a typical Chevron osteotomy bunion surgery or to the experimental group where they receive a Chevron osteotomy bunion surgery with an LSTR. * Complete surveys preoperatively and at 3, 6, and 12 months after surgery. * Receive routine x-rays pre and postoperatively to compare hallux valgus angle (HVA).

18+ yearsAll GendersNA
1 location
M

RECRUITING

Background and Rationale It has long been known that early and targeted acute-stage intervention is the best way to prevent chronic pain. For 15 years the Principal Investigator has been developing novel tools, strategies, and frameworks for predicting and preventing the acute-to-chronic transition in other populations. These include self-report tools that have individually demonstrated \>75% accuracy in predicting 12-month outcomes when administered in the first weeks from injury, new interpretations of common pain assessment and evaluation tools, and new frameworks for understanding pain and its management at both the acute and chronic stages. The investigators have used advanced analytic techniques to identify and describe the recovery trajectories present in a sample of people with mixed musculoskeletal injuries using data collected within days to weeks, predicting outcomes up to 12 months post-injury. In a recently-completed project, some of these innovations were integrated into a single online questionnaire targeting Canadian military veterans with chronic pain. The results of that analysis revealed a 5-cluster solution based on responses to self-report measures of 7 domains (or axes) of drivers of the pain experience. The investigators believe this strategy will also have value when translated and implemented in more acutely injured workers in Canada as a single risk stratification and management protocol. The longer-term goal is to use this type of simple self-assessment protocol to empower injured workers and claims managers to triage into the right care pathway, reduce time off work, and improve the likelihood of successful outcomes. Based on our team's extensive work in the prognosis of post-traumatic musculoskeletal injuries, the investigators propose that it is possible to identify those who can be expected to achieve a full return to work within only the programs of care and differentiate them from those who will experience some form of delayed or non-return to work and can do so within the first 3 weeks (21 days) from injury with \>80% accuracy. Objective Development and validation of a multi-axis 'risk/prognosis' worker-reported screening tool comprising tools that can be administered within the first 8 weeks of work-related injury and provide \>80% accuracy in predicting work recovery trajectories over the subsequent 2 months. Recruitment Recruitment will occur through CBIH programs of care provider clinics for injured workers, using both emailed and posted invitations. In both cases explicit opt-in consent will be obtained for this study following the protocol for digital online consent procedures from Western's Research Ethics Board (REB). Members of the research team at Western will monitor the portal for new participants daily. New participants will be entered into a Master List that includes only name, contact email address, and a study-specific randomly-generated 4-digit ID number. The Master List is necessary to permit the linking of responses across data collection periods and will be stored separately from the raw data file that will include only ID number. The research team member will subsequently create a unique survey link tied to the participant's email addresses and send that to the participant within two working days. That survey will start with the screening questions for inclusion. Those who pass the screen will proceed with the full set of survey questions, while those who are screen-failed will be presented with a thank participant screen and their study involvement will end. Upon entry into the Master List, follow-up dates at 1 and 2 months post-inception will be automatically calculated, and the research team members will use those to ensure follow-up survey forms are sent on time. Clinician Feedback: The emailed link to the clinician feedback survey will be sent to all members of the CBI Health Inc. network of physiotherapists in Canada, along with the new classification tool/algorithm. The CBI Health collaborators on this protocol will facilitate dissemination of the link through internal CBI Health email channels. Any clinician who is a registered physiotherapist within the CBI Health Inc. network will be eligible to participate. They will receive the new stratification algorithm and a link to a single-page feedback survey. In this way emails will be stored in a separate database from survey responses. The list of emails will remain with the Western researchers and will not be shared with the CBI Health leadership. Methodology This is an observational prospective inception cohort using data collected from injured workers entering one of the CBIH programs of care. Clinicians within this network provide care under a standardized framework that limits confounding from different interventions and the researchers will not manipulate treatment decisions. Duration: All eligible Workers will be invited to participate. Participants will be in the study for two months (8 weeks) total, from inception to outcome. A single interim data collection at 4 weeks post-inception will permit longitudinal trajectories to be established for each outcome as a tertiary analytic target (interpreted as slope/rate of recovery). DATA ANALYSIS: 1. Descriptive and bivariate associations to describe the sample and evaluate associations between the predictors and the outcomes; 2. Maximum likelihood-based latent profile analysis in which the predictors (and their subscales where available) are used to identify meaningful profiles ('clusters') of injured Workers. This will be guided by 3 core principles of i) statistical justification, ii) parsimony, and iii) clinical meaningfulness; 3. The profiles will then be evaluated to determine the proportion of successful primary (work) and secondary outcomes within each. The investigators anticipate that one profile will comprise a majority who achieve Full return to work by 8 weeks and another will comprise a majority who fail to achieve return to work, with other clusters including mixed outcomes. Prognostic accuracy of the new clusters will also be compared against the TIDS to determine whether the use of additional scales offers improved utility over the single scale. SAMPLE SIZE: Prior authors have endorsed at least 250 unique people in the data for robust Maximum likelihood-based latent profile analyses, and our own work in a sample of Canadian military veterans with chronic pain that used almost identical indicators to the current project successfully identified 5 latent classes with n = 322 respondents. The investigators will target up to n = 350 over a two-year project window. Quality Assurance: All Western members of the research team have completed either or both of the Good Clinical Practice or Tri-Council Policy Statement 2 training modules. Certificates of completion are available upon request. Further, the Principal Investigator has completed the CIHR Institute of Gender training module on sex- and gender-based analyses, Equity, Diversity and Inclusion training through Western University, and Ownership, Control, Access and Possession training for research with Indigenous peoples. The investigators acknowledge a potential for conflict of interest regarding the collaboration with the CBIH team. Importantly, CBIH will be instrumental for helping meet the recruitment targets as one of Canada's largest networks of rehabilitation providers for injured workers. Members of the CBIH team will also be critical for ensuring the design described herein can be expected to lead to implementable findings, and they will facilitate clinical interpretation of analytic results, and facilitate dissemination of the findings throughout their network of clinics. Importantly, all findings of this work will be published in scientifically-rigourous peer-reviewed journals relevant to the field, and no part of the data or findings will be the proprietary property of CBIH. Participants will be made aware of this arrangement prior to providing their informed consent to participate. Expected Outcomes: This work is anticipated to result in a new risk/prognosis screening tool to discriminate between those injured workers most likely to transition back to full return to work quickly from those most likely to experience delayed or incomplete recovery, and the investigators further anticipate that the latent classes identified will be useful for directing injured workers to the most appropriate health discipline in the patient-centred spirit of 'right care, right person, right time'. Logical next steps from this work will be to use the most accurate predictor variables found herein to create and test intervention strategies that specifically target the risks present in higher-risk injured workers. Through this program of research, the investigators anticipate reducing the burden of delayed return to work borne by both injured workers and those who insure them. Ethics: All methods for this study have been approved by the Health Sciences Research Ethics Board of Western University (London Ontario, Canada), REB No. 121883, having been evaluated by an independent peer reviewer against the standards of the Declaration of Helsinki and in accordance with the Tri-Council Policy Statement 2.

18-100 yearsAll Genders
1 location

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