Lateral Shelf Acetabuloplasty in Perthes Disease

January 24, 2020 updated by: Hesham Mohamed Elbaseet, Assiut University

Lateral Shelf Acetabuloplasty for Treatment of Older Children With Perthes Disease

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

Older children more than 8 years usually have a poor prognosis, especially without treatment. Apart from the age at diagnosis and surgery, the severity of femoral head flattening and the signs of "head at risk" are also associated with the final clinical outcome. The current surgical treatment options, including proximal femoral varus osteotomy, innominate osteotomy, lateral shelf acetabuloplasty,triple pelvic osteotomy, and Chiari pelvic osteotomy have proved to be effective in covering the femoral head within the acetabulum. To promote the coverage of the femoral head, shelf acetabuloplasty directly increases the size of the acetabulum by implanting graft bone to the lateral rim. When used as salvage surgery, it may provide relief from pain and benefit the involved hip via femoral head flattening, especially in older children. It also improves the spherical remodeling of the femoral head and acetabulum by stimulating lateral acetabular growth. Lateral shelf acetabuloplasty is able to increase the coverage of the femoral head, which is an important tissue for remodeling and preventing further femoral head deformation.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

      • Assiut, Egypt
        • Recruiting
        • AssiutU
        • Contact:

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

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris hip score
Time Frame: 6 months

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

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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, 2018

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

October 23, 2017

First Submitted That Met QC Criteria

October 24, 2017

First Posted (Actual)

October 25, 2017

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • LSAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Orthopedic Disorder

Clinical Trials on No intervention Observational study

3
Subscribe