Hip Reconstruction in Cerebral Palsy With Pelvic Osteotomy | NCT02372617

Studies
Hip Reconstruction in Cerebral Palsy With Pelvic Osteotomy

NCT02372617

Sponsor

Associação de Assistência a Criança Deficiente

Status

Unknown status

Last Update Posted

Jun 27, 2018Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Cerebral Palsy

Interventions

periacetabular osteotomy

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012Actual

Primary Completion Date

Jun 2020Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Feb 22, 2015

First Submission Date that Met QC Criteria

Feb 25, 2015

First Posted Date

Feb 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2018

Last Update Posted Date

Jun 27, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mauro Cesar de Morais Filho, Chief of Orthopedic Staff, Associação de Assistência a Criança DeficientePrincipal Investigator

Lead Sponsor

Associação de Assistência a Criança DeficienteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		bone graft - autologous	Procedure: periacetabular osteotomy
Group B		bone graft - ceramic	Procedure: periacetabular osteotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
periacetabular osteotomy	Procedure		Group A Group B

Measure	Description	Time Frame
Acetabular index		12 months

Measure	Description	Time Frame
Reimers Index		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hip subluxation > 40% and acetabular dysplasia

Exclusion Criteria:

previous hip surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AACD		São Paulo	São Paulo	04026001	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy
D004204	Joint Dislocations

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided