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Lateral Shelf Acetabuloplasty in Perthes Disease

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ClinicalTrials.gov Identifier: NCT03321422
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Hesham Mohamed Elbaseet, Assiut University

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.

Condition or disease Intervention/treatment
Orthopedic Disorder Other: No intervention Observational study

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
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lateral Shelf Acetabuloplasty for Treatment of Older Children With Perthes Disease
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020



Intervention Details:
  • Other: No intervention Observational study
    follow up of the function of the hip after lateral shelf acetabuloplasty by harris hip score and WOMAC score


Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Criteria

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

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): NCT03321422


Contacts
Contact: Nariman Abol Oyoun, MD 01222302343 Aboloyoun@yahoo.com
Contact: Mohamed Hassan, MD 01026161155 mohammedkhaledortho@gmail.com

Locations
Egypt
AssiutU Recruiting
Assiut, Egypt
Contact: Nariman Abol Oyoun, MD    01222302343    Aboloyoun@yahoo.com   
Sponsors and Collaborators
Assiut University

Publications:
Responsible Party: Hesham Mohamed Elbaseet, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03321422     History of Changes
Other Study ID Numbers: LSAP
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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