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

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ClinicalTrials.gov Identifier: NCT02676271
Recruitment Status : Completed
First Posted : February 8, 2016
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center

Brief 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.


Condition or disease Intervention/treatment
Legg-Calvé-Perthes Disease Procedure: Proximal varus derotational osteotomy

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Long Term Outcome of Varus Derotational Osteotomy for Legg-Calvé-Perthes' Disease
Study Start Date : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : October 2015



Intervention Details:
  • 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.
    Other Name: Femoral plate


Primary Outcome Measures :
  1. Clinical outcomes [ Time Frame: a follow-up 42.5 years from surgery ]
    The hip status was assessed by the Harris Hip Score (HHS)

  2. 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

  3. Radiographic outcomes [ Time Frame: a follow-up 42.5 years from surgery ]
    The degenerative changes were assessed by The Tonnis grade.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676271


Locations
Israel
Assaf Haroffeh Medical center
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Noam Shohat, MD Tel Aviv University, Israel

Responsible Party: Assaf Harofeh MC, Noam Shohat, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02676271     History of Changes
Other Study ID Numbers: 0063-15
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Legg-Calve-Perthes Disease
Femur Head Necrosis
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases