Prospective Evaluation of Treatment for Clubfoot

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.

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 Scottish Rite Hospital with good or fair results in 59% (23 of 39
feet) compared to fair and good results in 12% (4 of 33 feet) using traditional serial
casting. The Ponseti casting technique has also gained attention recently with 90% excellent
results reported by Noonan and 94% excellent results reported by Herzenberg. Evaluation and
improvement in these treatment protocols continues.

Patients, who fail to achieve a plantigrade foot with either of these methods, may be treated
surgically. Patients initially judged to have adequate correction, may later be noted to have
persistent or recurrent deformity and undergo surgical intervention. For patients who present
with a diagnosis of clubfoot that are beyond infancy surgery is the only option for
treatment. As with nonsurgical interventions, evaluation and improvement in surgical
techniques continues.

Reports quantifying functional outcome following surgical intervention for these patients is
lacking. For example, Garceau et al described and reported the results of transposition of
the anterior tibial tendon in patients with recurrent clubfoot. The procedure was described
to prevent recurrence of deformity caused by imbalance between muscles everting and inverting
the foot. Since this report, numerous authors have described results of the transfer of the
anterior tibial tendon for the treatment of residual or recurrent supination or adduction
deformity in idiopathic congenital clubfoot. However, none of these studies have been in done
in a prospective, quantitative manner and few have utilized measurements obtained through
gait analysis.

CONCISE SUMMARY OF PROJECT: 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

- Questionnaires - at age 4, age 10, and at skeletal maturity: patient/parent baseline
assessment.

- Radiographs- standing AP and laterals of both feet (for a total of 4 radiographs) will
be taken for all adult participants.

- Movement Science Lab- at 2, 5, 10 years of age and at skeletal maturity. This testing
may include walking with reflective markers and electrodes attached with tape to his/her
legs, walking across a pressure plate, video, digital pictures, wearing a step monitor,
strength testing, and an agility test.

- Physical therapy - at 5 years of age: developmental motor scale; at 10 years of age:
motor proficiency assessment; at skeletal maturity: motor proficiency and functional
symmetry assessments

- Brace compliance - each patient will have a temperature logger placed in a shoe of the
Dennis-Browne Bar at the initial fitting visit in the Orthotics department. At every
subsequent clinic follow-up visit, the Orthotist will download the time/temperature data
onto a laptop from the sensor reader (a piece of computer hardware that the sensor clips
into and is attached to the laptop via the USB port). The Orthotist will then reset the
temperature logger discs in order to monitor the next period of brace wear.

The following additional evaluations may be conducted on the patients who also have surgical
treatment of clubfoot:

Standard-of-care • Clinical exams and radiographs will be conducted as is required by the
surgeon. No additional radiographs are needed for investigational purposes.

Investigational

• Movement Science Lab testing may be done before surgery, 1, 2,5, and 10 years following
surgery, and at skeletal maturity.

In addition, relevant retrospective data from your child's medical chart including clinical
history, radiographs, and data collected in the Movement Science lab, may be used.

SOURCES OF RESEARCH MATERIAL:

Data collected for this research will include the following:

- Chart review - patient demographics

- Clinical exams - including use of Dimeglio classification to record treatment progress,
assessment by physical therapy

- Radiographs

- Questionnaires

- Movement Science Lab Assessment- using kinematics, kinetics, EMG, pedobarography, video,
digital pictures, step monitor, strength testing, and an agility test (Pedi-Champ).

- Peabody Developmental Motor Scales

- BOT-2: Bruininks-Oseretsky Test of Motor Proficiency

- Patient brace compliance, as recorded by sensor implanted in shoe

- Y Balance Test

Retrospective data from patients previously seen at Texas Scottish Rite Hospital for Children
may be used for this study if all inclusion criteria are met. Since retrospective data would
consist of collecting data from the patients' medical record only, a consent form for
retrospective data will not be used.

Prospective data from patients currently enrolled in clubfoot studies IRB#0101-037,
IRB#0401-220, IRB#0903-545 will be used for this study if all inclusion criteria are met.

RECRUITMENT OF SUBJECTS: All patients with a diagnosis of clubfoot who plan non surgical or
surgical treatment at TSRH will be invited to participate by their orthopedic physician and
his/her team.

Patients with the diagnosis of clubfoot, who have been discharged from care at TSRH, may be
invited to participate for long term follow up. These patients will be identified through
chart reviews. Study investigators will identify eligible patients, and will contact
prospective participants and ask them to participate. Retrospective data for these patients
will be combined with long-term follow-up data collected upon their enrollment.

Physicians/Investigators will only be recruiting their established patients and will not
recruit patients unrelated to their practice.

All patients treated with Denis Browne bar will be informed that temperature loggers are
going to be inserted in their orthoses, and that temperature information will be downloaded
at each visit. They will not be informed that the temperature information indicates whether
or not, and how often, the brace is worn. Informing them that the logger measures compliance
would influence the outcome of the study, and therefore cannot be shared with the patients.

POTENTIAL RISKS: The risk associated with participation for children in this study is no
different than the risk of a standard visit to an orthopedic surgeon at Texas Scottish Rite
Hospital for Children, including minimal radiation exposure for radiographic evaluation of
the feet. For adults in this study, all radiographs are considered investigational. The
amount of radiation exposure, in addition to Standard Care, that may be received in this
study is small; comparable to the everyday risk of driving 40 miles in an automobile.

There are inherent risks in the treatment of idiopathic clubfoot deformity, including
deformity, poor function, pain, need for surgery, cast problems (including skin breakdown,
infection, etc.), and neurovascular injury. The interventions being studied are those that
are currently being used for treatment of clubfoot deformity. These treatment protocols have
shown good evidence for reducing the incidence of the inherent risks in the treatment of
clubfoot deformity. Possible risks related to evaluation in the Movement Science Lab, may
include skin irritation from tape removal, and muscle soreness following strength testing.

There are no known physical risks associated with having the sensors (small discs about the
size of a nickel coin) attached to the inside sole area of the shoe.

SPECIAL PRECAUTIONS: The Radiology Department will follow standard shielding protocols during
each radiographic examination. Females 10 to 25 years of age will be required to complete and
sign (parent's signature required on children 17 years and under) the TSRHC Radiology
Department "Pregnancy Screening for Radiological Procedures" form prior to their Radiographic
evaluation.

PROCEDURES TO MAINTAIN CONFIDENTIALITY: All medical records and datasheets kept within TSRHC
are maintained in accordance with hospital policy on confidentiality of patient records and
services. All data will be kept in locked files and will be stored and managed in accordance
to HIPAA guidelines. No patient information will be disclosed. Signed consent forms will be
stored in the Orthopaedic Research Coordinator's Office.

There is the possibility that the IRB may review the research information. The IRB may review
data collected for the study, to insure that the research protocol is being followed and that
patient's rights are being upheld. The IRB may contact research participants to ensure
continuity in study records and ask participants about their experience with the study. This
information will be kept confidential in accordance with HIPPA guidelines.

POTENTIAL BENEFITS: This project will employ treatment protocols currently in use, but will
attempt to employ them in more controlled and consistent settings. Patients potentially
benefit by receiving treatment with improved outcomes compared to historic and traditional
treatment protocols.

RISK/BENEFIT ASSESSMENT: The goal of this study is to better quantify and follow the results
of treatment. The results of this study will help to improve treatment provided to future
patients. The investigators can not assure subjects that they will benefit from their
participation in this study, and no compensation will be offered for their participation.
This goals and methods of the project will be discussed with the subjects for purposes of
informed participation.

Inclusion Criteria:

- Patients with a diagnosis of clubfoot deformity

- Spanish speaking patients will be eligible to participate in the study.

Exclusion Criteria:

- All patients without a diagnosis of clubfoot