Prospective Evaluation of Treatment for Clubfoot
ConditionClubfoot Deformity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorTexas Scottish Rite Hospital for Children
About this trial
Specific aim:
To evaluate the outcome of infants who undergo one of two nonsurgical treatment interventions
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a diagnosis of clubfoot deformity
Spanish speaking patients will be eligible to participate in the study.
Disqualifiers
All patients without a diagnosis of clubfoot
Trial population
Primary care clinic
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Surgical
Procedure/SurgerySurgery only
Non-Surgical
Procedure/Surgerynon-surgical methods such as, casting, bracing, physical therapy, and other.
Non-surgical + surgical
Procedure/SurgeryCombination of non-surgical methods subsequently followed by surgery
Treatment groups
2,500 Participants
are divided into 3 treatment groupsGroup A: Surgical1 intervention
Group B: Non-Surgical1 intervention
Group C: Non-surgical + surgical1 intervention
Trial outcomes
Primary outcomes
1
Degree of correction at initial brace wear
Dimeglio scoring system will be used (score range from 0-20)
Time frame
2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov