Ponseti method is superior to surgical treatment in clubfoot - Long-term, randomized, prospective trial.

Treatment of idiopathic clubfoot has shifted from extensive surgical release to conservative Ponseti method; however, randomized prospective trials to compare both methods are lacking. The goal of this study was to compare the long-term results of Ponseti method with those of surgery in terms of morphology, function, X-rays, overall health and gait. In 2001, a single center, prospective, randomized, and controlled trial with a parallel design was started. Twenty-four feet of 15 patients were randomly assigned to two groups: 12 feet each to a Ponseti and surgical group. Mean follow-up was 10 years. International Clubfoot Study Group score (ICFSG), the Pediatric Outcomes Data Collection Instrument (PODCI) and the Functional Rating System (FRS) were used to compare morphology, functional, radiological and subjective outcomes, and the Oxford Foot Model (OFM) was used to evaluate foot kinematics. No significant difference was seen between groups in the initial Pirani scores (p=0.618). Ponseti group had more favorable long-term outcomes according to the FRS (p=0.005), higher ICFSG, scores for morphology (p=0.021), function (p=0.005) and X-rays (p=0.02), and better parent reported functional status according to the PODCI (p=0.018). Surgically treated clubfeet were stiffer - ankle dynamic range of motion (p=0.015) and the maximal hindfoot dorsiflexion during gait were limited as measured by OFM (p=0.039). This was compensated by an increase in motion between the hindfoot and forefoot. Furthermore, these children had more difficulty playing sports and experienced more pain, which might have led to inferior results in the happiness domain of the PODCI. These results suggest that the Ponseti method provides superior long-term outcomes for idiopathic clubfoot deformity.

RCT Entities:   Population Interventions Outcomes