NCT03321422

Brief Summary

The incidence of Legg-Calvé-Perthes disease (LCPD) ranges from 0.4/100,000 to 29.0/100,000 children \<15 years of age. There is significant variability in incidence within racial groups and is frequently higher in lower socioeconomic classes. The typical age at presentation ranges from 4 to 8 years (average 6.5 years).The optimal treatment goal in Legg-Calvé-Perthes disease (LCPD) is to obtain a spherical femoral head with good congruency to prevent or delay the onset of osteoarthritis after skeletal maturity. There is agreement that patients younger than 5years with a good remodeling capacity have a particularly excellent prognosis, irrespective of treatment.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2.8 years

First QC Date

October 23, 2017

Last Update Submit

January 24, 2020

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

  • Harris hip score

    Harris hip score is one of the most commonly used hip score for assessment of hip function.It assess the following items:Pain,support,distance walked, limp, activities-shoes and socks,stairs, public transportation, sitting,flexion deformity, abduction, adduction and external rotation range.The score of these items are summed together to get the total score. Grading according to this score as follows: \<70= Poor ,70 - 79= Fair, 80-89=Good, 90 -100=Excellent.

    6 months

Interventions

No intervention Observational studyOTHER

follow up of the function of the hip after lateral shelf acetabuloplasty by harris hip score and WOMAC score

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All patients will be admitted at orthopedic department of assiut university hospital. Clinical examination of the hip will be applied. Preoperative hip x ray anteroposterior and lateral views, Radiological classification and grading and clinical evaluation by Harris hip score. Hip arthrogram under general anasthesia . if hinged abduction shelf acetabuloplasty will be done. Follow up by x ray and harris hip score at regular visits ( 1.5, 6, 12,24 months)

You may qualify if:

  • Age between 8 up to 14 years
  • Patients with Perthes disease and hinged abduction .
  • Written consent, free and informed

You may not qualify if:

  • Age below 8 or above 14 years
  • Patients without hinged abduction based on clinical exam and arthrogram under general anaesthesia
  • Epiphyseal dysplasia
  • Coagulopathy
  • Unfit for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AssiutU

Asyut, Egypt

RECRUITING

Related Publications (3)

  • Chaudhry S, Phillips D, Feldman D. Legg-Calve-Perthes disease: an overview with recent literature. Bull Hosp Jt Dis (2013). 2014;72(1):18-27.

    PMID: 25150324BACKGROUND

  • Li WC, Xu RJ. Lateral shelf acetabuloplasty for severe Legg-Calve-Perthes disease in patients older than 8 years: A mean eleven-year follow-up. Medicine (Baltimore). 2016 Nov;95(45):e5272. doi: 10.1097/MD.0000000000005272.

    PMID: 27828848BACKGROUND

  • Jacobs R, Moens P, Fabry G. Lateral shelf acetabuloplasty in the early stage of Legg-Calve-Perthes disease with special emphasis on the remaining growth of the acetabulum: a preliminary report. J Pediatr Orthop B. 2004 Jan;13(1):21-8. doi: 10.1097/00009957-200401000-00004.

    PMID: 15091254BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Central Study Contacts

Nariman Abol Oyoun, MD

CONTACT

01222302343Aboloyoun@yahoo.com

Mohamed Hassan, MD

CONTACT

01026161155mohammedkhaledortho@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 25, 2017

Study Start

January 1, 2018

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)