Lateral Shelf Acetabuloplasty in Perthes Disease

Orthopedic Disorder Clinical Trial

Official title:

Lateral Shelf Acetabuloplasty for Treatment of Older Children With Perthes Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03321422
• Other study ID #: LSAP
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: November 2020

Study information

• Verified date: January 2020
• Source: Assiut University
• Contact: Nariman Abol Oyoun, MD
• Phone: 01222302343
• Email: Aboloyoun[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

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

Locations

Country	Name	City	State
Egypt	AssiutU	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Chaudhry S, Phillips D, Feldman D. Legg-Calvé-Perthes disease: an overview with recent literature. Bull Hosp Jt Dis (2013). 2014;72(1):18-27. Review. — View Citation

Jacobs R, Moens P, Fabry G. Lateral shelf acetabuloplasty in the early stage of Legg-Calvé-Perthes disease with special emphasis on the remaining growth of the acetabulum: a preliminary report. J Pediatr Orthop B. 2004 Jan;13(1):21-8. — View Citation

Li WC, Xu RJ. Lateral shelf acetabuloplasty for severe Legg-Calvé-Perthes disease in patients older than 8 years: A mean eleven-year follow-up. Medicine (Baltimore). 2016 Nov;95(45):e5272. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris hip score	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