Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy (Gait)
Recruitment status was: Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy|
- Gait Testing and Analysis [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
- Demographic Data:age;GA at birth; Prenatal DX;closure age;Pelvic osteotomies;Perioperative and late complications;Successful initial closure;Continence; Additional surgeries w/age [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Pediatric Outcomes Data Collection Instrument (PODCI) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Bladder Exstrophy Patients
Patients who receive follow-up care at Connecticut CMC urology clinic for bladder exstrophy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863070
|United States, Connecticut|
|Center for Motion Analysis|
|Farmington, Connecticut, United States, 06032|
|Connecticut Children's Medical Center|
|Hartford, Connecticut, United States, 06106|
|Principal Investigator:||John Makari, M.D.||Connecticut Children's Medical Center|