Hip Reconstruction in Cerebral Palsy With Pelvic Osteotomy

June 25, 2018 updated by: Mauro Cesar de Morais Filho, Associação de Assistência a Criança Deficiente
Prospective study enrolling patients with cerebral palsy and with subluxation of the hips > 40% and acetabular dysplasia. The patients will be stratified according the degree of subluxation and age. The treatment protocol is composed by femur variation osteotomy and periacetabular osteotomy. Patients will be divided in two groups according the type of bone graft used at periacetabular osteotomy (autologous or ceramic).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04026001
        • AACD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with cerebral palsy of AACD Cerebral Palsy Clinic, with progressive hip subluxation.

Description

Inclusion Criteria:

  • hip subluxation > 40% and acetabular dysplasia

Exclusion Criteria:

  • previous hip surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
bone graft - autologous
Procedure: periacetabular osteotomy
Group B
bone graft - ceramic
Procedure: periacetabular osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acetabular index
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reimers Index
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associação de Assistência a Criança Deficiente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 22, 2015

First Submitted That Met QC Criteria

February 25, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AACD 30/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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