View Clinical Trial (Medical Research Study)
Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy
| City: |
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Farmington |
| State: |
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Connecticut |
| Zip Code: |
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06032 |
| Conditions: |
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Bladder Exstrophy |
| Purpose: |
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The purpose of this study is to determine whether patients who have undergone exstrophy
closure may be at risk for long-term orthopedic issues manifest by gait abnormalities. This
study is a descriptive analysis of the study cohort's gait patterns and pelvic structure.
Specific Aim 1: to determine whether patients with classic bladder exstrophy who underwent
closure demonstrate gait abnormalities.
Hypothesis 1: Patients undergoing closure of bladder exstrophy (with or without pelvic
osteotomy) demonstrate gait abnormalities compared with a reference population.
Hypothesis 2: Patients undergoing closure of bladder exstrophy (with or without pelvic
osteotomy) will have below normal functional survey scores.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
1. Subject was seen at CCMC for bladder exstrophy between January 2002 and December
2010.
2. Subject is four years of age or older at time of enrollment.
3. Subject has the ability to walk.
4. Subject has not had gait testing performed.
5. Subject provides Informed Consent and HIPAA Authorization.
Exclusion Criteria:
1. Subject was not seen at CCMC for bladder exstrophy between January 2002 and December
2010.
2. Subject under four years of age at time of enrollment.
3. Subject does not have the ability to walk.
4. Subject had prior gait testing performed.
5. Subject not willing to provide Informed Consent and HIPAA Authorization.
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| NCT ID: |
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NCT00863070 |
| Primary Contact: |
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Principal Investigator John Makari, M.D. Connecticut Children's Medical Center
John Makari, M.D. Phone: 860-545-9520 Email: jmakari@ccmckids.org
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| Backup Contact: |
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Email: kherbst@ccmckids.org Katherine W. Herbst, M.Sc. Phone: 860-545-9520
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| Location Contact: |
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Farmington, Connecticut 06032 United States
John Makari, M.D. Phone: 860-545-9520 Email: jmakari@ccmckids.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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