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Foot Deformities clinical trials

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NCT ID: NCT06308380 Recruiting - Contracture Clinical Trials

Effectiveness of Rehabilitation Protocol in Patients With Shortened Posterior Leg Muscles

EREPSOLM
Start date: March 10, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical study is to develop a specialized rehabilitation exercise protocol designed for patients diagnosed with foot pathologies and calf muscle shortening, regardless of their choice to undergo minimally invasive ultrasound-guided surgery. The primary focus is to assess disparities in outcomes, particularly in the recovery of ankle mobility degrees. Additionally, for patients opting for minimally invasive ultrasound-guided surgery, the study aims to evaluate the resumption of both sporting activities and daily routines using the aforementioned specific rehabilitation protocol. The primary questions this study aims to answer are: - How does the proposed rehabilitation protocol impact ankle mobility recovery for patients with foot pathologies and calf muscle shortening? - What are the differences observed in the return to sporting activities and daily life among patients undergoing minimally invasive ultrasound-guided surgery, following the prescribed protocol? Participants enrolled in this study will be engaged in: Undertaking the specified rehabilitation exercises tailored for foot pathologies and calf muscle shortening. Those opting for minimally invasive ultrasound-guided surgery will follow the same rehabilitation protocol post-surgery to assess its impact on their return to normal activities. If there exists a comparison group: Researchers will compare participants who undergo minimally invasive ultrasound-guided surgery against those who choose other treatment options to discern any differential effects on ankle mobility recovery and resumption of activities.

NCT ID: NCT05643079 Recruiting - Clinical trials for Flexor Tendon Rupture

Medial Displacement Calcaneal Osteotomy and FDL- Transfer - With a Human, Allogeneic Cortical Bone Screw

Start date: February 10, 2022
Phase:
Study type: Observational

The goal of this observational study is to compare the use of a screw made of human bone (Shark-Screw®, Surgebright-GmbH) with the metal/Bio-Tenodesis screw (Arthrex) in the treatment of the symptomatic flatfoot using the medializing calcaneus osteotomy with flexor digitorum longus transfer (FDL) in adult patients. The advantage of the human bone screw is that after surgery no hardware removal is necessary. The screw is transformed from the body to normal bone. The main questions it aims to answer are: - Can the human bone screw achieve union rates like the metal/Bio-Tenodesis screw? - Is the time to union similar between the different screws? - Is the complication rate similar between the different screws? - Are the activity scores American Orthopaedic Foot and Ankle Society (AOFAS), Foot and Ankle Outcome Score (FAOS) and Foot Function Index (FFI) after surgery similar in the compared patient groups? Participants will have - the surgery - follow-ups at 6 weeks, 6 months, 1 and 2 years. - X-rays are performed at each follow up. - CT-scans are performed after 6 months. - activity scores are collected at the follow up after 6 months, 1 year and 2 years.

NCT ID: NCT05555459 Recruiting - Hallux Valgus Clinical Trials

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

Start date: September 28, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05129540 Recruiting - Foot Deformity Clinical Trials

Foot Orthoses in Patients With Sciatica

Start date: November 17, 2022
Phase: N/A
Study type: Interventional

Chronic sciatica is a frequent problem whose symptoms could be related to the abnormal stresses applied to the musculoskeletal system during the gait cycle due to foot alterations. The objectives of this study are to describe the main foot alterations in patients with chronic sciatica, and to evaluate whether foot orthoses can help alleviate this pain. Patients with chronic sciatica caused by lumbar disc herniation will be recruited and randomly allocate to one of both groups: one group that will be treated with custom-made foot orthoses, and one group that will be treated with a placebo orthotic device. Quality of life, pain in low-back, lower limb and foot, and disability caused by foot pain will be recorded at baseline, and after a two-month follow-up period.

NCT ID: NCT04766684 Recruiting - Clubfoot Clinical Trials

Comparison Study of LMX4 Cream Versus J-Tip Needle-Free Injection System With Lidocaine for In-Office PAT for Clubfoot

Start date: June 1, 2021
Phase: Phase 4
Study type: Interventional

Infants undergoing Ponseti treatment for idiopathic clubfoot often require percutaneous tendoachilles lengthening (TAL) after serial casting. This procedure is commonly performed in the office with a local anesthetic to avoid exposure to general anesthesia in the operating room. Topical anesthetic creams are commonly used to provide local analgesia for this procedure. The cream is applied to the infant's skin around the heel cord and requires 30-60 minutes to provide adequate analgesia, reaching a depth of up to 5 mm at maximum effect. Alternative to analgesic cream, the J-tip is a needle-free jet injection system that uses compressed CO2 instead of a needle to push 0.25 ml of lidocaine into the skin, providing local analgesia at the site of administration. This method likewise provides analgesia to the site of application at a depth of 5-8 mm, yet only takes approximately 1-2 minutes to achieve maximum effect. Aim 1: Determine which pain management method, L.M.X.4 Cream vs. J-tip 1% Xylocaine MPF Injection, provides the greatest pain relief to infants with clubfoot undergoing an in-office percutaneous TAL. Hypothesis: J-tip 1% Xylocaine MPF injection will provide equal or greater pain control when compared to L.M.X.4 cream in infants undergoing an in-office percutaneous TAL. Aim 2: Determine if there is a difference in the rate of adverse events between the two pain management methods, L.M.X.4 Cream vs. J-tip 1% Xylocaine MPF Injection. Hypothesis: J-tip 1% Xylocaine MPF injection will not be associated with an increased rate of adverse events in comparison to L.M.X.4 cream in infants undergoing an in-office percutaneous TAL. If J-tip Xylocaine MPF injection is shown to provide comparable or better pain control without an increase in adverse events, use of this needle-free injection system will decrease the overall length of visit and the cost of the procedure, thus increasing the quality, safety, and value.

NCT ID: NCT04673669 Recruiting - Clinical trials for Valgus Foot Deformity

Measurement of the Strength of the Posterior Tibial Muscle by Hand-held Dynamometer

TPHHD
Start date: March 23, 2021
Phase: N/A
Study type: Interventional

Adult flat foot valgus is a degenerative pathology that causes damage to the ligaments of the hindfoot as well as dysfunction of the tendon of the posterior tibial muscle. Currently, there is a lack of a tool allowing a standardized, reliable, reproducible and validated measurement of the strength of the tendon of the posterior tibial muscle in consultation of foot surgery. The hand-held dynamometer could be that tool. The study would consist in measuring the strength of the tendon of the posterior tibial muscle in healthy subjects with a hand-held dynamometer (MicroFET2) by two examiners and compared to isometric reference measurements (CON-TREX CMV Multi-Joint) to validate the reliability of the measurement and its reproducibility.

NCT ID: NCT04564430 Recruiting - Trigger Finger Clinical Trials

Clonidine for Tourniquet-related Pain in Children

CLOTCH
Start date: March 1, 2021
Phase: Phase 4
Study type: Interventional

This study is designed as a randomized, placebo-controlled, double-blinded, clinical trial with two parallel groups. This study investigates the association between a single dose of the drug, Clonidine, and the total amount of opioid administered under and 24 hours after surgery in children undergoing orthopedic limb surgery with the use of tourniquet. The investigators hypothesize that administration of clonidine to children undergoing limb surgery with the use of inflatable tourniquets would reduce post-procedural pain. This study is a pilot to obtain an effect size. Based on this the investigators will calculate a sample size for the main trial enabling us to reach a power of 0.8 with a significans level of 0.05.

NCT ID: NCT02856321 Recruiting - Clinical trials for Equinus Foot Deformity in Children With Cerebral Palsy

PerLE (Peroneus Longus Evaluation): A Study Evaluating the Efficacy of Injection of Dysport in Peroneus Longus in Equinus Foot Deformity in Children With Cerebral Palsy

PerLE
Start date: January 2016
Phase: N/A
Study type: Observational

A recent publication (Boulay et al. 2012) highlighted the role of the peroneus longus (PL) muscle in equinus foot deformity in children with hemiplegia. BoNT (Dysport) injections into this muscle have not yet been described in the literature. Based on the results of a previous study, the hypothesis is: this muscle may thus constitute a new therapeutic target for botulinum toxin injections in the early management of spastic equinus in children aged 2 years or older, before the onset of fixed neuro-orthopedic deformity and the midfoot break. The aim of this retrospective study is to describe in intramuscular BoNT (Dysport) injections into PL based on the results obtained in a cohort of children (approximately 30 subjects) with cerebral palsy (hemiplegia or diplegia) and which have been treated in the service since 2007 until July 2012. The investigators results are based on clinical, radiological and video evaluations. For this study, data will be collected in medical folder of each children belonging to this cohort. All children (approximately 30 subjects) with cerebral palsy (hemiplegia or diplegia) which have been treated by BoNT (Dysport) intramuscular injections into PL in the service between 2007 and July 2012 will be screened. Subjects will be selected according to the following defined inclusion and exclusion criteria. Data will be collected retrospectively (using a specific case report form designed for the study) in medical folder of each included subject for all visit of follow-up after BoNT (Dysport) injection into PL (since the first BoNT (Dysport) injection up to 2012). Then, data will be entered in a database. After that, they will be analysed .

NCT ID: NCT02257229 Recruiting - Clubfoot Deformity Clinical Trials

Prospective Evaluation of Treatment for Clubfoot

Start date: August 2005
Phase:
Study type: Observational

Specific aim: To evaluate the outcome of infants who undergo one of two nonsurgical treatment interventions

NCT ID: NCT02093507 Recruiting - Clinical trials for Foot Deformity Congenital

Effectiveness of Parent's Manipulation in Newborn With Metatarsus Adducts. a Randomized Controlled Trial

Start date: May 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the result of parent's feet manipulation compared with nonmanipulated group within first 6 months of life and observe spectrum of the disease within this period.