Quality of LifeNCT03860025
"Patient Reported Outcome After Dislocation of a Primary THA"
An observational study of Quality of Life and Hip Dislocation, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The aim is to compare QOL and hip specific outcome measures in patients with a single or recurrent episode(s) of THA dislocation and patients with a THA without any dislocation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Quality of Life, Hip Dislocation
- How many people
- 4,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2019to 1 Aug 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 40 years and older
- All sexes
- Adult, Older adult
Study population: The patients had undergone primary surgery in the 5-year period from 01.01.2010 - 31.12.2014 and subsequent dislocation was evaluated in a 2-year follow-up period. Cases are found in a previously described study (Protocol-ID 3-3013-2128/1). 1100-1800 cases will be identified, anticipated. A matched control group of patients with primary THA without any event of dislocation are located from the original 5-year period of primary surgery. They will be matched with the group of patients with dislocation, regarding to: 1. Age (+/- 5 years) 2. Gender 3. Date of surgery and hospital
Who may be able to join
- patients with one or more events of hip dislocation after a primary THA
- controls with a primary THA without events of hip dislocation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to compare QOL and hip specific outcome measures in patients with a single or recurrent episode(s) of THA dislocation and patients with a THA without any dislocation.
Read the detailed description
Knowledge about the patient's own perception of both general health and more hip-related issues after experiencing a hip dislocation is lacking (19). Hip surgeons need this information in order to incorporate it with other objective aspects, when advising patients with their first hip dislocation. Due to the large study population, this study will provide solid information of what to expect after a hip dislocation and be the largest study ever conducted within this topic. Depending on the results, this study may change the path we choose to advise for our patients after single or recurrent dislocations.
A matched case-control study involving the share of THA patients with at least 1 episode of hip dislocation.
The patients had undergone primary surgery in the 5-year period from 01.01.2010 - 31.12.2014 and subsequent dislocation was evaluated in a 2-year follow-up period. Given a 3-5% approximated incidence of dislocation, 1100-1800 cases will have been identified.
Patients are subdivided in groups depending on the number of dislocations and one group containing THA revisions. In order to be included, a time frame of at least 0,5 year since the last episode of dislocation or surgery must have passed.
A matched control group of patients with primary THA without any event of dislocation are located from the original 5-year period of primary surgery. They will be matched with the group of patients with dislocation, regarding to:
- Age (+/- 5 years)
- Gender
- Date of surgery and hospital
The study will be conducted in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
After 01.01.2019, all patients included will be receiving 3 questionnaires (a generic - EQ-5D, a hip-specific - HOOS, and an activity scale - UCLA) by e-boks (a mandatory secure email system couplet to the patient's CPR number). Some elderly are exempt and will instead receive the questionnaires by regular mail and a pre-labeled return envelope is attached. Reminders are sent after 2 months.
- Conditions
- Quality of Life, Hip Dislocation
- Being tested
- No intervention.
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Single dislocation. | Patients with a single postoperative hip dislocation without subsequent revision surgery. Receives: Other: No intervention. | |
| Recurrent dislocation. | Patients with two or more postoperative hip dislocations without subsequent revision surgery. Receives: Other: No intervention. | |
| Revision due to dislocation. | Patients with one or more postoperative hip dislocations with subsequent revision surgery due to recurrent instability. Receives: Other: No intervention. | |
| Controls. | Matched patients without postoperative hip dislocation or revision of any reason. Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
QOL (Quality of life)
Measured by the EQ-5D questionnaire.
Measured: 9 years
Hip function
Measured by the HOOS questionnaire.
Measured: 9 years
Secondary outcomes (1)
Activity
Measured by the UCLA activity questionnaire.
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Jan 2019
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars L. Hermansen, MD, Principal investigator, Department of Clinical Research, Odense University Hospital, Odense, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860025
- Sponsor's protocol ID
- 3-3013-2128/2
- Status last verified
- Feb 2019
- First submitted
- 28 Feb 2019
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data not to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Patient Reported Outcome After Dislocation of a Primary THA"
- ClinicalTrials.gov ID
- NCT03860025
- Acronym / sponsor ID
- 3-3013-2128/2
- Conditions
- Quality of Life, Hip Dislocation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 1 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.
The aim is to compare QOL and hip specific outcome measures in patients with a single or recurrent episode(s) of THA dislocation and patients with a THA without any dislocation.
Detailed description
Knowledge about the patient's own perception of both general health and more hip-related issues after experiencing a hip dislocation is lacking (19). Hip surgeons need this information in order to incorporate it with other objective aspects, when advising patients with their first hip dislocation. Due to the large study population, this study will provide solid information of what to expect after a hip dislocation and be the largest study ever conducted within this topic. Depending on the results, this study may change the path we choose to advise for our patients after single or recurrent dislocations.
A matched case-control study involving the share of THA patients with at least 1 episode of hip dislocation.
The patients had undergone primary surgery in the 5-year period from 01.01.2010 - 31.12.2014 and subsequent dislocation was evaluated in a 2-year follow-up period. Given a 3-5% approximated incidence of dislocation, 1100-1800 cases will have been identified.
Patients are subdivided in groups depending on the number of dislocations and one group containing THA revisions. In order to be included, a time frame of at least 0,5 year since the last episode of dislocation or surgery must have passed.
A matched control group of patients with primary THA without any event of dislocation are located from the original 5-year period of primary surgery. They will be matched with the group of patients with dislocation, regarding to:
- Age (+/- 5 years)
- Gender
- Date of surgery and hospital
The study will be conducted in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
After 01.01.2019, all patients included will be receiving 3 questionnaires (a generic - EQ-5D, a hip-specific - HOOS, and an activity scale - UCLA) by e-boks (a mandatory secure email system couplet to the patient's CPR number). Some elderly are exempt and will instead receive the questionnaires by regular mail and a pre-labeled return envelope is attached. Reminders are sent after 2 months.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single dislocation. | – | Other: No intervention.Patients with a single postoperative hip dislocation without subsequent revision surgery. |
| Recurrent dislocation. | – | Other: No intervention.Patients with two or more postoperative hip dislocations without subsequent revision surgery. |
| Revision due to dislocation. | – | Other: No intervention.Patients with one or more postoperative hip dislocations with subsequent revision surgery due to recurrent instability. |
| Controls. | – | Other: No intervention.Matched patients without postoperative hip dislocation or revision of any reason. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients had undergone primary surgery in the 5-year period from 01.01.2010 - 31.12.2014 and subsequent dislocation was evaluated in a 2-year follow-up period. Cases are found in a previously described study (Protocol-ID 3-3013-2128/1). 1100-1800 cases will be identified, anticipated. A matched control group of patients with primary THA without any event of dislocation are located from the original 5-year period of primary surgery. They will be matched with the group of patients with dislocation, regarding to: 1. Age (+/- 5 years) 2. Gender 3. Date of surgery and hospital
Key inclusion criteria (2 listed)
- patients with one or more events of hip dislocation after a primary THA
- controls with a primary THA without events of hip dislocation
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 |
|---|---|---|
| No intervention.No intervention. | Other | Controls., Recurrent dislocation., Revision due to dislocation., Single dislocation. |
Primary outcome
QOL (Quality of life)
Time frame: 9 years
Measured by the EQ-5D questionnaire.
Hip function
Time frame: 9 years
Measured by the HOOS questionnaire.
1 secondary outcome
Activity
Time frame: 9 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Individual participant dataSharing planned: No. Data not to be shared.
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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.
Lars L. Hermansen, MD principal investigator
Department of Clinical Research, Odense University Hospital, Odense, Denmark.
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 Quality of Life and Hip Dislocation, run by University of Southern Denmark at 1 site in Denmark.
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: status not confirmed, as of the sponsor's last update on 1 Mar 2019. 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 Denmark. 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?
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?
QOL (Quality of life) (time frame: 9 years). 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 1 Mar 2019.