Orthopedic DisorderNCT03321422
Lateral Shelf Acetabuloplasty in Perthes Disease
An observational study of Orthopedic Disorder, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Orthopedic Disorder
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
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)
Who may be able to join
- Age between 8 up to 14 years
- Patients with Perthes disease and hinged abduction .
- Written consent, free and informed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AssiutU
Asyut
Nariman Abol Oyoun, MD, 01222302343, Aboloyoun@yahoo.com
About this study
Official title: Lateral Shelf Acetabuloplasty for Treatment of Older Children With Perthes Disease
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.
Read the 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.
- Conditions
- Orthopedic Disorder
- Being tested
- No intervention Observational study
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention Observational studyOther
follow up of the function of the hip after lateral shelf acetabuloplasty by harris hip score and WOMAC score
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 Jan 2018
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Mohamed Elbaseet, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321422
- Sponsor's protocol ID
- LSAP
- Status last verified
- Jan 2020
- First submitted
- 23 Oct 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chaudhry S, Phillips D, Feldman D. Legg-Calve-Perthes disease: an overview with recent literature. Bull Hosp Jt Dis (2013). 2014;72(1):18-27.
PubMed 25150324Li WC, Xu RJ. Lateral shelf acetabuloplasty for severe Legg-Calve-Perthes disease in patients older than 8 years: A mean eleven-year follow-up. Medicine (Baltimore). 2016 Nov;95(45):e5272. doi: 10.1097/MD.0000000000005272.
PubMed 27828848Jacobs R, Moens P, Fabry G. Lateral shelf acetabuloplasty in the early stage of Legg-Calve-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. doi: 10.1097/00009957-200401000-00004.
PubMed 15091254
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Shelf Acetabuloplasty for Treatment of Older Children With Perthes Disease
- ClinicalTrials.gov ID
- NCT03321422
- Acronym / sponsor ID
- LSAP
- Conditions
- Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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)
Key inclusion criteria (3 listed)
- Age between 8 up to 14 years
- Patients with Perthes disease and hinged abduction .
- Written consent, free and informed
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention Observational studyfollow up of the function of the hip after lateral shelf acetabuloplasty by harris hip score and WOMAC score | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Background: PubMed 25150324Chaudhry S, Phillips D, Feldman D. Legg-Calve-Perthes disease: an overview with recent literature. Bull Hosp Jt Dis (2013). 2014;72(1):18-27.
- Background: PubMed 27828848Li WC, Xu RJ. Lateral shelf acetabuloplasty for severe Legg-Calve-Perthes disease in patients older than 8 years: A mean eleven-year follow-up. Medicine (Baltimore). 2016 Nov;95(45):e5272. doi: 10.1097/MD.0000000000005272.
- Background: PubMed 15091254Jacobs R, Moens P, Fabry G. Lateral shelf acetabuloplasty in the early stage of Legg-Calve-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. doi: 10.1097/00009957-200401000-00004.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nariman Abol Oyoun, MD (01222302343, Aboloyoun@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris hip score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03321422, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.