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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Connecticut Children's Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT00863070
First received: March 16, 2009
Last updated: June 14, 2011
Last verified: June 2011

March 16, 2009
June 14, 2011
April 2009
April 2012   (final data collection date for primary outcome measure)
Gait Testing and Analysis [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00863070 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy
Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Bladder exstrophy patients receiving follow-up services at Connecticutcmc Urology clinic.

Bladder Exstrophy
Not Provided
Bladder Exstrophy Patients
Patients who receive follow-up care at Connecticut CMC urology clinic for bladder exstrophy.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8
June 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
4 Years to 65 Years
No
Contact: John Makari, M.D. 860-545-9520 jmakari@ccmckids.org
Contact: Katherine W. Herbst, M.Sc. 860-545-9520 kherbst@ccmckids.org
United States
 
NCT00863070
09-003
No
John Makari, M.D./Pediatric Urologist, Connecticut Children's Medical Center
Connecticut Children's Medical Center
Not Provided
Principal Investigator: John Makari, M.D. Connecticut Children's Medical Center
Connecticut Children's Medical Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP