Legg-Calvé-Perthes DiseaseNCT02676271
The Long Term Outcome of Varus Derotational Osteotomy for Legg-Calvé-Perthes' Disease
An observational study of Legg-Calvé-Perthes Disease, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Legg-Calvé-Perthes Disease
- What is being tested?
- Proximal varus derotational osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2015to Oct 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All patients were treated in our institution during 1959 to 1983 with proximal VDRO and were examined a decade ago
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Legg-Calvé-Perthes Disease
- Being tested
- Proximal varus derotational osteotomy
- Medical subject headings
- Legg-Calve-Perthes Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal varus derotational osteotomyProcedure or surgery
Also called Femoral plate
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes
The hip status was assessed by the Harris Hip Score (HHS)
Measured: a follow-up 42.5 years from surgery
Clinical outcomes
The Short Form-36 (SF-36) was used to asses the general well being
Measured: a follow-up 42.5 years from surgery
Radiographic outcomes
The degenerative changes were assessed by The Tonnis grade.
Measured: a follow-up 42.5 years from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Legg-Calvé-Perthes DiseaseStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
- Investigators
- Noam Shohat, MD, Principal investigator, Tel Aviv University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676271
- Sponsor's protocol ID
- 0063-15
- Status last verified
- Feb 2016
- First submitted
- 24 Nov 2015
- Last updated
- 8 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long Term Outcome of Varus Derotational Osteotomy for Legg-Calvé-Perthes' Disease
- ClinicalTrials.gov ID
- NCT02676271
- Acronym / sponsor ID
- 0063-15
- Conditions
- Legg-Calvé-Perthes Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Feb 2016 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients were treated in our institution during 1959 to 1983 with proximal VDRO and were examined a decade ago
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Proximal varus derotational osteotomyAlso: Femoral plateThe 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. | Procedure or surgery | – |
Primary outcome
Clinical outcomes
Time frame: a follow-up 42.5 years from surgery
The hip status was assessed by the Harris Hip Score (HHS)
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
Radiographic outcomes
Time frame: a follow-up 42.5 years from surgery
The degenerative changes were assessed by The Tonnis grade.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
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Early Feasibility Study of Cartilage Defect Repair
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Alendronate for Osteonecrosis in Adults With Sickle Cell Disease
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Mixed-Methods Evaluation of Short-, Medium-, and Long-Term Outcomes Following Hip Treatment
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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.
Noam Shohat, MD principal investigator
Tel Aviv University, Israel
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 Legg-Calvé-Perthes Disease, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Feb 2016. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes (time frame: a follow-up 42.5 years from surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2016.