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

Legg-Calvé-Perthes Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676271
• Other study ID #: 0063-15
• Status: Completed
• Phase: N/A
• First received: November 24, 2015
• Last updated: February 5, 2016
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Legg-Calvé-Perthes Disease

Intervention

Procedure:
• Proximal varus derotational osteotomy
The purpose of surgery was to relocate the protruded, deformed femoral head from its lateral position back to the acetabulum to achieve containment. Surgery was preceded by a hip arthrography with dynamic examination to find the suitable containment position and plan the correct osteotomy angles accordingly. A sub trochanteric osteotomy was performed then after in an open or closed wedge form, with fixation in an angle that gave best coverage.

Locations

Country	Name	City	State
Israel	Assaf Haroffeh Medical center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcomes	The hip status was assessed by the Harris Hip Score (HHS)	a follow-up 42.5 years from surgery	No
Primary	Clinical outcomes	The Short Form-36 (SF-36) was used to asses the general well being	a follow-up 42.5 years from surgery	No
Primary	Radiographic outcomes	The degenerative changes were assessed by The Tonnis grade.	a follow-up 42.5 years from surgery	No