An observational study in Clubfoot, sponsored by Texas Scottish Rite Hospital for Children. Completed at 1 site in United States. Open to participants aged 1 Week to 75 Years. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by Texas Scottish Rite Hospital for Children · Observational
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Among 10 studies in Clubfoot with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Clubfoot · United States.
Among the 10 studies in Clubfoot with a site in United States, this one is the only one that started in 2008, is one of 5 observational ones, and was the 2nd registered.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
Browse Clubfoot studies →2 of the 10 studies in Clubfoot with a site in United States are open now. Recruiting first, the newest first:
University of Wisconsin, Madison · Sites in United States
Ages 0 wk–12 wk
Texas Scottish Rite Hospital for Children · Sites in United States
Ages up to 18
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 10 Clubfoot studies recruiting now, none (0%) set no upper age limit and 10 (100%) stop at 75 or younger; 9 take children under 18; none take healthy volunteers.
This study: 1 Week to 75 Years · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2008.
This study's enrollment of 379 is above the median of 55 across 27 observational studies indexed under Clubfoot.
Median enrollment 100 across the 5 interventional studies, 370 across the 5 observational. Of the 8 that completed or were terminated, 4 (50%) have results posted.
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None of the 10 has an industry lead sponsor. The 8 most frequent:
Texas Scottish Rite Hospital for Children is the lead sponsor of 18 studies on the registry; 6 are open to participants now.
Texas Scottish Rite Hospital for Children has 2 studies filed under Clubfoot — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Clubfoot with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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To build a DNA repository to enable participation in ongoing and future Clubfoot genetic linkage studies.
Clubfoot is a birth defect that can occur alone (in isolation) or as a part of a disease like cerebral palsy (CP). Genetic linkage is a research tool in which DNA samples are tested for genetic landmarks (markers) whose location on chromosomes is known. Genes and markers that are physically close to one another on the chromosome are said to be tightly linked than genes and markers that are located far apart. This gives clues of where to search for genes causing isolated clubfoot. If there appears to be a high correlation between family members' inheritance of a particular marker, and their inheritance of the trait being studied (in this case clubfoot), the area of the chromosome near that marker can then be searched for a likely gene which causes the trait. It is hoped that genetic linkage research might eventually result in new or improved ways to determine individuals and families at higher risk for clubfoot and development of new or improved ways to treat clubfoot.
Our research staff will obtain information about each subject and their family called a pedigree. We will then administer a one page questionnaire to the mother(s) of the affected individual(s). This questionnaire will ask about the mother's experiences during pregnancy (e.g. Did she take multivitamins? Did she smoke or drink? etc.)
Each of the study participants (affected and non-affected individuals) will be asked to provide DNA from a blood sample. If collecting a blood sample is not possible we can also obtain DNA by collecting a saliva sample.
Samples for DNA processing will be stored according to the following repository guidelines. Patient/donor-subject information, questionnaires, and consents will be maintained by the orthopaedic research coordinator.
Samples will be made to investigators not affiliated with UT Southwestern who wish to study genetic factors that cause clubfoot; for example, we have recently been approached by Jacqueline Hecht (UT Health Science Center, Houston) and Matthew Dobbs (Washington University, St. Louis) regarding participation in their multicenter trials. Samples will be de-identified and will include no personal information which would link the sample to the donor subject.
Primary investigator and sub-investigators will determine how samples will be used and by whom. Additional research utilizing subjects' samples will be approved by the Texas Scottish Rite Hospital for Children Research Advisory Panel and the Institutional Review Board at UT Southwestern.
Patients being treated at the participating facilities with a diagnosis of clubfoot, and their affected family members.
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Exclusion Criteria:
To identify a gene, or genes, that are associated with isolated clubfoot.
Time frame: 10 years
New or improved ways to determine individuals and families at higher risk for clubfoot and development of new or improved ways to treat clubfoot.
Time frame: 10 years
Plan to share: Undecided
The record gives a start of Jan 2008, a primary completion of May 2017 and a completion of May 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Texas Scottish Rite Hospital for Children