Clinical Trial: Prospective Evaluation of Treatment for Clubfoot

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational




Official Title: Prospective Evaluation of Treatment for Clubfoot

Brief Summary:

All patients who meet inclusion criteria and who agree to participate in the study will be evaluated for classification of clubfoot reducibility (Dimeglio 1995), which characterizes the four components of clubfoot deformity including equinus, heel varus, calcaneopedal rotation, and forefoot adduction.

Patients will be allowed to select treatment with either the daily massage and taping technique or the Ponseti casting technique. It is not practical or feasible to randomize patients as transportation and scheduling, as well as family preference and willingness to participate, are primary factors in the French physical therapy method of massage/taping.

Once treatment intervention has been determined, patients will be enrolled into the surgical or one of two non surgical arms (French physical therapy or Ponseti casting) of the study. Research participation entails the retrospective and prospective review of data collected through standard medical care.

All patients who undergo clubfoot treatment, may have the following evaluations:

Standard-of-care

  • Clinical exams- will be conducted at the initial visit, 4 weeks, 8 weeks, 12 to 14 weeks, 6 months, and 9 months following treatment. Also at 1 year, 18 months, 2 years, 3 years, 4 years, 5 years, and 10 years of age and at skeletal maturity.
  • Radiographs- standing AP and laterals of both feet may be taken at 18 months, 4 years of age, and at skeletal maturity (for a total of 12 possible radiographs over the span of the study).

Investigational