NCT00958464

Brief Summary

The purpose of this study is to determine whether Perthes' disease has caused detectable hip cartilage damage in young people who have reached the healed stage of the disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

9.4 years

First QC Date

August 11, 2009

Last Update Submit

October 2, 2019

Conditions

Keywords

MRIPerthes'diseasehipcartilage

Outcome Measures

Primary Outcomes (1)

  • Whether Perthes' disease has caused detectable hip cartilage damage in young people who have reached the healed stage of the disease.

    2 days

Study Arms (1)

1

MRI protocol on 2 separate occasions

Procedure: MRI

Interventions

MRIPROCEDURE

MRI protocol consists of intravenous injection of 0.4 ml/kg dose of gadopentetate dimeglumine 2- \[Gd-DTPA2-\] contrast agent (Magnevist, Bayer) 90 minutes prior to imaging.

1

Eligibility Criteria

Age17 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Volunteers with healed unilateral Perthes' disease between the ages of 7-18 years

You may qualify if:

  • Subjects must have reached the healed stage of unilateral Perthes' disease. -Subjects will be between 7 and 18 years of age.
  • Subjects must understand English.

You may not qualify if:

  • Subjects will be excluded if they have bilateral Perthes' disease or if they have not yet reached the healing stage of the disease.
  • Subjects will also be excluded if they do not meet the criteria to have an MRI (e.g., the subject has metal implants, is claustrophobic, has a metallic object in eye or a pacemaker).
  • A subject will be excluded if they have any of the precautions for the MR contrast agent, Magnevist, such as pregnancy, breast-feeding, respiratory allergies, asthma, thrombotic syndromes, history of grand mal seizures, impaired renal or hepatic function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children's Hospital, Department of Orthopaedics

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Legg-Calve-Perthes Disease

Condition Hierarchy (Ancestors)

Femur Head NecrosisOsteonecrosisBone DiseasesMusculoskeletal Diseases

Study Officials

  • Kishore Mulpuri, Dr.

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • David Wilson, Dr.

    University of British Columbia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 13, 2009

Study Start

January 1, 2008

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 3, 2019

Record last verified: 2019-10

Locations