Legg Calve Perthes DiseaseNCT03885960
Perthes Disease in Norway
An observational study of Legg Calve Perthes Disease, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Calvé-Legg-Perthes disease (CLP) is a hip disease in children whose femoral head becomes completely or partially necrotic. The disease is most common in five-six years of age. The femoral head is gradually deformed during the active stages of the disease (5-7 years). Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Legg Calve Perthes Disease
- How many people
- 216 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2018to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: All patients which have been diagnosed with Perthes disease in between 1996 and 2000 in Norway were registered and follow at least 5 years after diagnosis. All hospitals throughout Norway with orthopaedic service were included in the registration. Our study is a 20 years follow-up of the original study.
Who may be able to join
- Subject was diagnosed with Perthes disease between 1996 and 2000 in Norway
Who cannot join
- Death upon follow up
- Other skeletal dysplasia
- Patient not able to give consent,
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital - Rikshospitalet
Oslo, Sognsvannsveien 20, 0372
About this study
Official title: A Prospective Nationwide Study of Perthes' Disease in Norway: Functional and Radiographic Outcomes at a Mean Follow-up of Twenty Years
Calvé-Legg-Perthes disease (CLP) is a hip disease in children whose femoral head becomes completely or partially necrotic. The disease is most common in five-six years of age. The femoral head is gradually deformed during the active stages of the disease (5-7 years). By healing, the hip joint shape will vary from an approximately normal joint to pronounced changes, the hip joint will be irregular. Such a hip joint is available for osteoarthritis. The purpose of this study is to map the function of the hip, the patient's quality of life and especially the risk factors that affect the outcome of the previous CLP. A nationwide prospective study of CLP was conducted between 1996 and 2000. All children with newly diagnosed Perthes disease (425) were registered. The current study will follow up all these patients with an average follow-up of 20 years. Radiological endpoints are evidence of hip osteoarthritis. Patient-reported outcomes (PROMS) should illuminate the function of the hip and quality of life.
- Conditions
- Legg Calve Perthes Disease
- Keywords
- Hip, function, quality of life, osteoarthritis, Perthes, LCPD
- Medical subject headings
- Legg-Calve-Perthes Disease, Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip osteoarthritis
radiographic measurement of weight bearing zone
Measured: an average of 20 years follow-up
Hip function
PROMS HOOS
Measured: an average of 20 years follow-up
Secondary outcomes (3)
Hip ROM
functional test of range of motion of the hip
Measured: an average of 20 years follow-up
Gluteal muscle strength
Trendelenburg test
Measured: an average of 20 years follow-up
Hip strength
single leg hop test - 6 meters
Measured: an average of 20 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start1 Nov 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Legg Calve Perthes DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sophies Minde Ortopedi
- Responsible party
- Principal investigator, Stefan Huhnstock, Oslo University Hospital
- Investigators
- Stefan Huhnstock, Phd, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885960
- Sponsor's protocol ID
- 2018/1924
- Status last verified
- Mar 2025
- First submitted
- 9 Jan 2019
- Last updated
- 18 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Nationwide Study of Perthes' Disease in Norway: Functional and Radiographic Outcomes at a Mean Follow-up of Twenty Years
- ClinicalTrials.gov ID
- NCT03885960
- Acronym / sponsor ID
- 2018/1924
- Conditions
- Legg Calve Perthes Disease
- Keywords
- Hip, function, quality of life, osteoarthritis, Perthes, LCPD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sophies Minde Ortopedi
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Mar 2019 (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.
Calvé-Legg-Perthes disease (CLP) is a hip disease in children whose femoral head becomes completely or partially necrotic. The disease is most common in five-six years of age. The femoral head is gradually deformed during the active stages of the disease (5-7 years). By healing, the hip joint shape will vary from an approximately normal joint to pronounced changes, the hip joint will be irregular. Such a hip joint is available for osteoarthritis. The purpose of this study is to map the function of the hip, the patient's quality of life and especially the risk factors that affect the outcome of the previous CLP. A nationwide prospective study of CLP was conducted between 1996 and 2000. All children with newly diagnosed Perthes disease (425) were registered. The current study will follow up all these patients with an average follow-up of 20 years. Radiological endpoints are evidence of hip osteoarthritis. Patient-reported outcomes (PROMS) should illuminate the function of the hip and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients which have been diagnosed with Perthes disease in between 1996 and 2000 in Norway were registered and follow at least 5 years after diagnosis. All hospitals throughout Norway with orthopaedic service were included in the registration. Our study is a 20 years follow-up of the original study.
Key inclusion criteria (1 listed)
- Subject was diagnosed with Perthes disease between 1996 and 2000 in Norway
Key exclusion criteria (3 listed)
- Death upon follow up
- Other skeletal dysplasia
- Patient not able to give consent,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hip osteoarthritis
Time frame: an average of 20 years follow-up
radiographic measurement of weight bearing zone
Hip function
Time frame: an average of 20 years follow-up
PROMS HOOS
3 secondary outcomes
Hip ROM
Time frame: an average of 20 years follow-up
Gluteal muscle strength
Time frame: an average of 20 years follow-up
Hip strength
Time frame: an average of 20 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
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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.
Stefan Huhnstock, Phd principal investigator
Oslo University Hospital
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 Calve Perthes Disease, run by Oslo University Hospital at 1 site in Norway.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2025. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hip osteoarthritis (time frame: an average of 20 years follow-up). The study lists 2 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 18 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.