Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy

Completed

• Conditions: Bladder Exstrophy

• Registration Number: NCT00863070
• Lead Sponsor: Connecticut Children's Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-16
• Study First Posted: 2009-03-17
• Study Start: 2009-04
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gait Testing and Analysis	2 Weeks

Secondary Outcome Measures

Name	Time	Method
Demographic Data:age;GA at birth; Prenatal DX;closure age;Pelvic osteotomies;Perioperative and late complications;Successful initial closure;Continence; Additional surgeries w/age	2 weeks
Pediatric Outcomes Data Collection Instrument (PODCI)	2 weeks

Trial Locations

Locations (2)

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States

Center for Motion Analysis; 🇺🇸 Farmington, Connecticut, United States