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

  • PURPOSE: The purpose of this project is to help orthopaedic surgeons better understand and treat patients with a diagnosis of clubfoot. This proposed research will establish a protocol for the collection of relevant clinical and functional outcome measures on our patients with a diagnosis of clubfoot.

    The specific aims are as follows:

    1. To evaluate the outcome of infants who undergo one of two nonsurgical treatment interventions
    2. To evaluate the outcome of surgical intervention in pediatric patients

    3. To compare the long-term outcome of patients who receive

      1. nonsurgical treatment only
      2. nonsurgical early intervention with subsequent surgery and

      3. surgical intervention only.

        BACKGROUND: The goal of treatment for clubfoot deformity is to obtain a functional, pain-free, plantigrade foot, with good mobility, and without callosities.

        Nonsurgical treatment options are available for the infant patient with a diagnosis of clubfoot. Traditional non-operative treatment of clubfoot deformity with serial casting as described historically by Kite successfully treats only 15% percent of patients reported by McKay, 60% of patients reported by Harrold, and 64% reported by Price. Alternative treatment techniques have been developed, including the Ponseti casting technique and the French physical therapy method. The French physical therapy method of daily massage and taping has been implemented at Texas Scottis
        Sponsor: Texas Scottish Rite Hospital for Children

        Current Primary Outcome: Level of Foot correction [ Time Frame: At skeletal maturity ( more or less 14-19 years of age) ]

        Original Primary Outcome: Same as current

        Current Secondary Outcome:

        Original Secondary Outcome:

        Information By: Texas Scottish Rite Hospital for Children

        Dates:
        Date Received: September 22, 2014
        Date Started: August 2005
        Date Completion: September 2029
        Last Updated: October 1, 2014
        Last Verified: October 2014