The Long Term Outcome of Varus Derotational Osteotomy for Legg-Calvé-Perthes' Disease

February 5, 2016 updated by: Assaf Harofeh MC, Assaf-Harofeh Medical Center

Background: Varus derotation osteotomy (VDRO) is one of the most popular surgical treatments for Legg-Calvé-Perthes disease yet its long term results have not been assessed. Our purpose was to determine the long term clinical and radiographic outcomes of these patients.

Methods: Forty patients (43 hips) who had undergone VDRO for LCPD who participated in a long term follow-up study a decade ago were approached for the present study.

All patients were treated in our institution during 1959 to 1983 with proximal VDRO.

The patients were invited to for a medical interview and a physical examination. They were also asked to fill out questionnaires and to provide or undergo a standing anteroposterior (AP) pelvic and a lateral hip radiographs during the visit.

Patients were asked to self-grade their hip pain as none, mild, moderate or severe and to grade their back pain using the Visual Analogue Scale (VAS) between 0-10. Details regarding daily function, physical activity, work status and family history were obtained. All participants completed the Harris Hip Score (HHS) with a maximum score of 100 and the Short Form-36 which is composed of 8 sections and has a maximum score of 100.

The physical examination included an assessment of the hip range of motion, leg length discrepancy and the presence of a Trendelenburg sign.

Radiographic parameters evaluated were the Tonnis grade (with a score between 0-3), head size ratio, and the center-edge (CE) angle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

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

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Assaf Haroffeh Medical Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Forty patients (43 hips) who had undergone VDRO for LCPD who participated in a long term follow-up study a decade ago. All patients were treated in our institution during 1959 to 1983 with proximal VDRO.

Description

Inclusion Criteria:

  • All patients were treated in our institution during 1959 to 1983 with proximal VDRO and were examined a decade ago

Exclusion Criteria:

-

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: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes
Time Frame: a follow-up 42.5 years from surgery
The hip status was assessed by the Harris Hip Score (HHS)
a follow-up 42.5 years from surgery
Clinical outcomes
Time Frame: a follow-up 42.5 years from surgery
The Short Form-36 (SF-36) was used to asses the general well being
a follow-up 42.5 years from surgery
Radiographic outcomes
Time Frame: a follow-up 42.5 years from surgery
The degenerative changes were assessed by The Tonnis grade.
a follow-up 42.5 years from surgery

Collaborators and Investigators

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

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Noam Shohat, MD, Tel Aviv University, Israel

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

March 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 8, 2016

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0063-15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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