Hip DislocationNCT03859791
"True Incidence of Hip Dislocation After Primary THA - a Nationwide Population Study"
An observational study of Hip Dislocation, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The primary objective is to report the true incidence of hip dislocations in primary THA patients within 2 years of index surgery. Secondary, patient and component characteristics (age, sex, comorbidity, cemented/uncemented, approach, head diameter) are analyzed as potential risk factors for dislocation. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Dislocation
- What is being tested?
- THA
- How many people
- 32,500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2018to 1 Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Retrospective, we include patients with the diagnosis "primary/idiopathic hip OA". Patients are identified by data extraction from the Danish Hip Arthroplasty Registry. From 2010-2014 an average of 9000 hips/year received a primary THA and about 80% of these patients were diagnosed with idiopathic/primary arthritis. Therefore, we tend to include approximately 36.000 hips. We also include the second hip, if a patient undergoes 2 primary operations in our inclusion period and this is adjusted for in the analysis.
Who may be able to join
- patients with the diagnosis "primary/idiopathic hip OA and inserted THA from 01.01.2010 - 31.12.2014.
Who cannot join
- patients receiving a resurfacing hip arthroplasty and hip revisions
- patients with incomplete registry data
- patients with previous hip surgery
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to report the true incidence of hip dislocations in primary THA patients within 2 years of index surgery.
Secondary, patient and component characteristics (age, sex, comorbidity, cemented/uncemented, approach, head diameter) are analyzed as potential risk factors for dislocation. Specific components may be analyzed based on number.
Read the detailed description
Based on published literature and personal experience, most hip surgeons have an assumption of the degree of hip dislocation. This will be the first study to reveal the actual extent of this specific complication in a large population. It will give surgeons knowledge of the current standards -both on a national and hospital level. Depending on the results and comparisons to relevant countries, the investigators will be able to either substantiate or forced to rethink current procedures. This applies to both surgical access and use of specific components.
Since the vast majority of dislocations appear within 1-2 years after primary surgery (29), the follow-up period will be 2 years. By applying the National Patient Registry the investigators are able to identify any type of patient contact with the hospital system throughout Denmark in these 2 years. Patients assigned with correct diagnostic and procedural codes for dislocation and reduction are identified. However, the investigators will also find the cases of dislocation that are incorrectly coded in the registry. Therefore, the investigators will manually look in all the patient files from orthopedic contacts regardless of assigned diagnostic and procedural codes. Additionally, emergency room and internal medicine contacts are scanned with a broad and comprehensive range of relevant hip- and dislocation-related codes to identify episodes of hip dislocation, which are incorrectly coded. These patient files will also be manually reviewed.
If a patient is revised within the first 2 years, the follow-up period ends on the revision date. Revisions are also registered in the Danish Hip Arthroplasty Registry. However, the completeness is 93-95% and therefore lower than for primary operations. In order to have the complete set of revisions, the investigators will enrich our data with an extraction from the National Patient Registry by applying all approved hip revision codes
- Conditions
- Hip Dislocation
- Being tested
- THA
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THAOther
Study participants have received a total hip arthroplasty due to arthritis. We do not make further intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip dislocation
The true incidence of hip dislocation calculated as proportion presented with 95% confidence intervals (CI).
Measured: 2 years.
Secondary outcomes (8)
Age
Potential risk factor found by logistic regression analysis
Measured: 2 years.
Sex
Potential risk factor found by logistic regression analysis
Measured: 2 years.
Comorbidity
Potential risk factor found by logistic regression analysis
Measured: 2 years.
Fixation of components
Potential risk factor found by logistic regression analysis
Measured: 2 years.
Surgical approach
Potential risk factor found by logistic regression analysis
Measured: 2 years.
Head diameter of prosthesis
Potential risk factor found by logistic regression analysis
Measured: 2 years.
Time to dislocation
Time to first dislocation presented by Kaplan-Meier plot.
Measured: 2 years.
Development in complication (dislocation) over time.
Incidence each year (2010-2014) calculated as proportion presented with 95% confidence intervals (CI) and compared statistically depending on distribution.
Measured: 5 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 2018
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DislocationStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Lykke Hermansen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859791
- Sponsor's protocol ID
- 3-3013-2128/1
- Status last verified
- Feb 2019
- First submitted
- 21 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 will not 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
- "True Incidence of Hip Dislocation After Primary THA - a Nationwide Population Study"
- ClinicalTrials.gov ID
- NCT03859791
- Acronym / sponsor ID
- 3-3013-2128/1
- Conditions
- Hip Dislocation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32,500 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Oct 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 primary objective is to report the true incidence of hip dislocations in primary THA patients within 2 years of index surgery.
Secondary, patient and component characteristics (age, sex, comorbidity, cemented/uncemented, approach, head diameter) are analyzed as potential risk factors for dislocation. Specific components may be analyzed based on number.
Detailed description
Based on published literature and personal experience, most hip surgeons have an assumption of the degree of hip dislocation. This will be the first study to reveal the actual extent of this specific complication in a large population. It will give surgeons knowledge of the current standards -both on a national and hospital level. Depending on the results and comparisons to relevant countries, the investigators will be able to either substantiate or forced to rethink current procedures. This applies to both surgical access and use of specific components.
Since the vast majority of dislocations appear within 1-2 years after primary surgery (29), the follow-up period will be 2 years. By applying the National Patient Registry the investigators are able to identify any type of patient contact with the hospital system throughout Denmark in these 2 years. Patients assigned with correct diagnostic and procedural codes for dislocation and reduction are identified. However, the investigators will also find the cases of dislocation that are incorrectly coded in the registry. Therefore, the investigators will manually look in all the patient files from orthopedic contacts regardless of assigned diagnostic and procedural codes. Additionally, emergency room and internal medicine contacts are scanned with a broad and comprehensive range of relevant hip- and dislocation-related codes to identify episodes of hip dislocation, which are incorrectly coded. These patient files will also be manually reviewed.
If a patient is revised within the first 2 years, the follow-up period ends on the revision date. Revisions are also registered in the Danish Hip Arthroplasty Registry. However, the completeness is 93-95% and therefore lower than for primary operations. In order to have the complete set of revisions, the investigators will enrich our data with an extraction from the National Patient Registry by applying all approved hip revision codes
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective, we include patients with the diagnosis "primary/idiopathic hip OA". Patients are identified by data extraction from the Danish Hip Arthroplasty Registry. From 2010-2014 an average of 9000 hips/year received a primary THA and about 80% of these patients were diagnosed with idiopathic/primary arthritis. Therefore, we tend to include approximately 36.000 hips. We also include the second hip, if a patient undergoes 2 primary operations in our inclusion period and this is adjusted for in the analysis.
Key inclusion criteria (1 listed)
- patients with the diagnosis "primary/idiopathic hip OA and inserted THA from 01.01.2010 - 31.12.2014.
Key exclusion criteria (3 listed)
- patients receiving a resurfacing hip arthroplasty and hip revisions
- patients with incomplete registry data
- patients with previous hip 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 |
|---|---|---|
| THAStudy participants have received a total hip arthroplasty due to arthritis. We do not make further intervention. | Other | – |
Primary outcome
Hip dislocation
Time frame: 2 years.
The true incidence of hip dislocation calculated as proportion presented with 95% confidence intervals (CI).
8 secondary outcomes
Age
Time frame: 2 years.
Sex
Time frame: 2 years.
Comorbidity
Time frame: 2 years.
Fixation of components
Time frame: 2 years.
Surgical approach
Time frame: 2 years.
Head diameter of prosthesis
Time frame: 2 years.
Time to dislocation
Time frame: 2 years.
Development in complication (dislocation) over time.
Time frame: 5 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 will not 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 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: 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?
Hip dislocation (time frame: 2 years.). 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.