NCT02372617

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

8.4 years

First QC Date

February 22, 2015

Last Update Submit

June 25, 2018

Conditions

Cerebral Palsy

Keywords

cerebral palsyhipluxationsubluxation

Outcome Measures

Primary Outcomes (1)

  • Acetabular index

    12 months

Secondary Outcomes (1)

  • Reimers Index

    12 months

Study Arms (2)

Group A

bone graft - autologous

Procedure: periacetabular osteotomy

Group B

bone graft - ceramic

Procedure: periacetabular osteotomy

Interventions

periacetabular osteotomyPROCEDURE
Group AGroup B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • hip subluxation \> 40% and acetabular dysplasia

You may not qualify if:

  • previous hip surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AACD

São Paulo, São Paulo, 04026001, Brazil

Location

MeSH Terms

Conditions

Cerebral PalsyJoint Dislocations

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesJoint DiseasesMusculoskeletal DiseasesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Orthopedic Staff

Study Record Dates

First Submitted

February 22, 2015

First Posted

February 26, 2015

Study Start

January 1, 2012

Primary Completion

June 1, 2020

Study Completion

December 1, 2022

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

BR(1)