Avascular Necrosis of the Femoral HeadAVNNCT03753282
Outcome After Avascular Necrosis of the Femoral Head in Young Patients
An observational study of Avascular Necrosis of the Femoral Head, run by University Hospital, Basel, Switzerland.
Trial summary
1. The course of AVN between Initial diagnosis and total hip replacement (THA) is analysed. The impact of early interventions versus conservative therapy in AVN before THA will be evaluated. 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Avascular Necrosis of the Femoral Head
- What is being tested?
- questionnaires for patient reported outcome and questionnaire for course of the disease
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2019to 5 Mar 2019
- 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: Population 1: Patients with a first AVN-related contact (initial or confirmed diagnosis) at the USB or KSBL Liestal in the years between 1999-2006. Population 2: Patients with a THA because of AVN at the USB or KSBL Liestal in the years 2000-2007.
Who may be able to join
- MRI of the hip available from diagnosis at the USB or KSBL Liestal
- Informed Consent
Who cannot join
- Insufficient knowledge of project languages (English, German, French)
About this study
Official title: Outcome After Avascular Necrosis of the Femoral Head in Young Patients - Retrospective Analysis With a Min. 10-year Follow-up
- The course of AVN between Initial diagnosis and total hip replacement (THA) is analysed. The impact of early interventions versus conservative therapy in AVN before THA will be evaluated.
- The short and long term outcomes of AVN patients undergoing THA with respect to complications, reoperations and quality of life are investigated. Potential risk factors for adverse outcomes will be investigated.
Read the detailed description
The study is to describe the course of avascular necrosis (AVN) of the femoral head from initial diagnosis and to collect data on treatment options and the further course in these cases. The duration from initial diagnosis of AVN to joint replacement as total hip arthroplasty (THA) will be analysed and the course after joint replacement with potential short- and long-term complications will be evaluated.
The impact of THA after AVN on activities of daily living will be assessed by Euroquol 5 Dimensions (EQ-5D-5L) and Hip disability and Osteoarthritis Outcome Score (HOOS) questionnaires.
- Conditions
- Avascular Necrosis of the Femoral Head
- Being tested
- questionnaires for patient reported outcome, questionnaire for course of the disease
- Keywords
- Total hip arthroplasty, Total hip replacement
- Medical subject headings
- Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires for patient reported outcomeOther
questionnaires with respect to outcomes:
- Reoperations
- Short term complications
- Long term complications
- EQ-5D (current)
- HOOS (current)
- disease related change of occupation
- use of walking aids
- comorbidities
- medication
questionnaire for course of the diseaseOther
questionnaires to assess course of the disease:
- from initial diagnosis of AVN to joint replacement as total hip arthroplasty (THA)
- therapeutic interventions
| Study group | Role | What they receive |
|---|---|---|
| Population 1 | Patients with a first AVN-related contact (initial or confirmed diagnosis) at the Universitätsspital Basel (USB) or Kantonsspital Basel-Liestal (KSBL) in the years between 1999-2006 (being assessed by questionnaires for patient reported outcome and questionnaire for course of the disease) Receives: Other: questionnaires for patient reported outcome; Other: questionnaire for course of the disease | |
| Population 2 | Patients with a THA because of AVN in the years 2000-2007 (being assessed by questionnaires for patient reported outcome and questionnaire for course of the disease) Receives: Other: questionnaires for patient reported outcome; Other: questionnaire for course of the disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
arthroplasty-free interval (time until THA)
time from first diagnosis of AVN to joint replacement = time to event data (in the years between 1999-2006)
Measured: single time point assessment at baseline
rate of reoperations after THA
reoperation after THA = time to event data (in the years between 2000-2007)
Measured: single time point assessment at baseline
Secondary outcomes (2)
Hip disability and Osteoarthritis Outcome Score (HOOS)
40 item questionnaire to assess patient-relevant outcomes in five separate subscales (pain, symptoms, activity of daily living, sport and recreation function and hip related quality of life). Scores are: None, Mild, Moderate, Severe, Extreme
Measured: single time point assessment at baseline
Euroquol 5 Dimensions (EQ-5D-5L)
Five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: single time point assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start30 Jan 2019
- Primary completion5 Mar 2019
- Study completion5 Mar 2019
Why it stopped: difficulty enrolling patients, no patient recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avascular Necrosis of the Femoral HeadStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franziska Saxer, Dr. med, Principal investigator, Dep. of Orthopedic and Trauma Surgery; University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753282
- Sponsor's protocol ID
- 2018-01264; ch18Saxer3
- Other IDs
- 2018
- Acronym
- AVN
- Status last verified
- Mar 2019
- First submitted
- 23 Nov 2018
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome After Avascular Necrosis of the Femoral Head in Young Patients - Retrospective Analysis With a Min. 10-year Follow-up
- ClinicalTrials.gov ID
- NCT03753282
- Acronym / sponsor ID
- AVN / 2018-01264; ch18Saxer3
- Conditions
- Avascular Necrosis of the Femoral Head
- Keywords
- Total hip arthroplasty, Total hip replacement
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: difficulty enrolling patients, no patient recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 26 Nov 2018 (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 course of AVN between Initial diagnosis and total hip replacement (THA) is analysed. The impact of early interventions versus conservative therapy in AVN before THA will be evaluated.
- The short and long term outcomes of AVN patients undergoing THA with respect to complications, reoperations and quality of life are investigated. Potential risk factors for adverse outcomes will be investigated.
Detailed description
The study is to describe the course of avascular necrosis (AVN) of the femoral head from initial diagnosis and to collect data on treatment options and the further course in these cases. The duration from initial diagnosis of AVN to joint replacement as total hip arthroplasty (THA) will be analysed and the course after joint replacement with potential short- and long-term complications will be evaluated.
The impact of THA after AVN on activities of daily living will be assessed by Euroquol 5 Dimensions (EQ-5D-5L) and Hip disability and Osteoarthritis Outcome Score (HOOS) questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population 1 | – | Other: questionnaires for patient reported outcome, Other: questionnaire for course of the diseasePatients with a first AVN-related contact (initial or confirmed diagnosis) at the Universitätsspital Basel (USB) or Kantonsspital Basel-Liestal (KSBL) in the years between 1999-2006 (being assessed by questionnaires for patient reported outcome and questionnaire for course of the disease) |
| Population 2 | – | Other: questionnaires for patient reported outcome, Other: questionnaire for course of the diseasePatients with a THA because of AVN in the years 2000-2007 (being assessed by questionnaires for patient reported outcome and questionnaire for course of the disease) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population 1: Patients with a first AVN-related contact (initial or confirmed diagnosis) at the USB or KSBL Liestal in the years between 1999-2006. Population 2: Patients with a THA because of AVN at the USB or KSBL Liestal in the years 2000-2007.
Key inclusion criteria (2 listed)
- MRI of the hip available from diagnosis at the USB or KSBL Liestal
- Informed Consent
Key exclusion criteria (1 listed)
- Insufficient knowledge of project languages (English, German, French)
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 |
|---|---|---|
| questionnaires for patient reported outcomequestionnaires with respect to outcomes: * Reoperations * Short term complications * Long term complications * EQ-5D (current) * HOOS (current) * disease related change of occupation * use of walking aids * comorbidities * medication | Other | Population 1, Population 2 |
| questionnaire for course of the diseasequestionnaires to assess course of the disease: * from initial diagnosis of AVN to joint replacement as total hip arthroplasty (THA) * therapeutic interventions | Other | Population 1, Population 2 |
Primary outcome
arthroplasty-free interval (time until THA)
Time frame: single time point assessment at baseline
time from first diagnosis of AVN to joint replacement = time to event data (in the years between 1999-2006)
rate of reoperations after THA
Time frame: single time point assessment at baseline
reoperation after THA = time to event data (in the years between 2000-2007)
2 secondary outcomes
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: single time point assessment at baseline
Euroquol 5 Dimensions (EQ-5D-5L)
Time frame: single time point assessment at baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
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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.
Franziska Saxer, Dr. med principal investigator
Dep. of Orthopedic and Trauma Surgery; University Hospital Basel
Questions about this trial
What is this clinical trial studying?
An observational study of Avascular Necrosis of the Femoral Head, run by University Hospital, Basel, Switzerland.
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 2 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: withdrawn, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
arthroplasty-free interval (time until THA) (time frame: single time point assessment at baseline). 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 29 Mar 2019.