Clinical Research Directory

Clubfoot Tenotomy Trial

Infants undergoing Ponseti treatment for idiopathic clubfoot often require percutaneous tendoachilles lengthening (TAL) after serial casting. This procedure is frequently 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 achilles tendon and requires 30 minutes to provide adequate analgesia, reaching a depth of up to 5 mm at maximum effect. An alternative is a needle-free jet injection system that uses compressed CO2 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, topical anesthetic cream (4% liposomal lidocaine) vs. jet infection of local anesthesia (1% lidocaine), provides the greatest pain relief to infants with clubfoot undergoing an in-office percutaneous TAL. Hypothesis: Jet injection will provide equal or greater pain control when compared topical anesthetic cream. Aim 2: Determine if there is a difference in the rate of adverse events between the two pain management methods, topical anesthetic cream (4% liposomal lidocaine) vs. jet infection of local anesthesia (1% lidocaine). Hypothesis: Jet injection of local anesthesia will not be associated with an increased rate of adverse events in comparison to topical anesthetic cream. If jet injection of local anesthesia 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 the procedure visit, thus increasing quality, safety, and value.

Comparison of Surgical Blade No. 11 and Ophthalmic Knife in Idiopathic Clubfoot Patients

There is limited local data available on the comparison between surgical blade no.11 and ophthalmic knife among patients with neglected clubfoot going through tenotomy. The study has been planned with the objective of comparing the effectiveness of surgical blade no. 11 and ophthalmic knife for percutaneous Achilles tendon tenotomy in Idiopathic clubfoot patients

Ultrasound Assessment of Achilles Tendon-Neurovascular Distance in Infants With Unilateral Clubfoot

This study aims to assess the distance between the Achilles tendon and nearby neurovascular bundles bilaterally in infants with unilateral clubfoot deformity using ultrasound (US)- Doppler at 1 cm and 2 cm above the calcaneal tuberosity.

Predictive Value of the PBS-score in Children With Clubfoot

Evaluate the predictive value of the PBS-score in predicting recurrence of idiopathic clubfoot, measured as need for additional treatment.

Health-Related Quality of Life in Children and Adolescents With Clubfoot

This prospective cohort study aims to evaluate the health-related quality of life (HRQoL) in children aged 2 to 15 years with congenital clubfoot, treated primarily according to the Ponseti method. The study will assess HRQoL using the Pediatric Quality of Life Inventory (PedsQL 4.0) and clinical outcomes using the PBS Clubfoot Score (PBS). Participants will be followed for 2 and 5 years to evaluate changes in HRQoL and clinical function. The primary objective is to understand the long-term impact of clubfoot and its treatment on patients' physical, emotional, and social well-being.

Evertor Muscle Activity as a Predictor of Achilles Tenotomy in the Management of Idiopathic Varus Equinus Clubfoot

Clubfoot is an orthopedic congenital malformation of the lower limb of the newborn evaluated by the Dimeglio score. There is a deficit of muscular balance between the agonists and antagonists to the deformity. The Dimeglio score takes into account the muscular activity but only up to one point out of 20. This study proposes to use a muscle scale inspired by the Dimeglio score to see if there is a correlation between muscle activity and the risk of tenotomy before 1 year. It will also assess the inter-examiner reproducibility of this scale. This study is a prospective cohort study with a duration of 8 years to include about 100 feet. Infants with idiopathic Clubfoot treated with the functional method at up to 15 days of life will be included. Feet will be assessed at an inclusion visit and then at 3-6-12 months. The primary endpoint will be the need for Achilles tenotomy before 1 year of age. The secondary endpoint will be inter-examiner reproducibility determined by statistical analysis. The expectation of this study would be to define a predictive factor of the evolution of the PBVE in order to refine the treatment earlier.