Clubfoot Tenotomy Trial

Clubfoot is a common congenital birth deformity, with a prevalence of approximately 1 in 1000 live births. Without treatment, clubfoot can cause significant disability. Percutaneous tendoachilles lengthening (TAL) is commonly required to correct residual equinus deformity during the Ponseti method. TAL may be performed in the operating room under general anesthesia or in outpatient settings using local anesthesia, but evidence guiding optimal anesthetic strategies for in office procedures remains limited.

Effective pain control in infancy is critical. Experimental and clinical studies demonstrate that repeated early life painful stimuli lead to hyperinnervation, heightened sensitivity, altered stress responses, and lower pain thresholds later in life. Cumulative procedural pain is associated with poorer cognitive and developmental outcomes and early interventions to reduce pain lessen cortisol exposure and improve neurobehavioral trajectories. Poorly controlled pain during neonatal or early childhood procedures has also been linked to altered pain behaviors during later procedures, emphasizing the long lasting impact of early nociceptive experiences.

Existing approaches for in office TAL include needle infiltration of local anesthetic or application of topical anesthetic cream. Needle infiltration may create soft tissue swelling that obscures the tenotomy site and increases procedural difficulty, and both techniques have been associated with substantial infant distress despite adequate application.

Needle free jet injection offers a potential alternative. Prior studies demonstrate that jet injection produces less pain than conventional needle infiltration and provides superior analgesia to topical anesthetics for procedures such as venipuncture, intravenous catheter placement, and lumbar puncture.

The Clubfoot Tenotomy Trial (ClubTT) was designed to evaluate whether jet injected local anesthesia provides equivalent analgesic efficacy without increasing adverse events compared with topical anesthesia for infants with idiopathic clubfoot undergoing in office TAL.

Inclusion criteria

• Clubfoot patients less than 6 weeks of age at start of casting
• Patients requiring in-office percutaneous achilles lengthening (TAL) following serial casting

Exclusion criteria

• Clubfoot patients greater than 6 weeks of age at the start of casting
• Previous clubfoot treatment
• Patients with a neuromuscular condition (spina bifida, caudal regression syndrome, arthrogryposis, etc.)
• In-office TAL is not recommended by treating physician