"True Incidence of Hip Dislocation After Primary THA - a Nationwide Population Study"
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|ClinicalTrials.gov Identifier: NCT03859791|
Recruitment Status : Active, not recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
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.
|Condition or disease||Intervention/treatment|
|Hip Dislocation||Other: THA|
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 Type :||Observational|
|Actual Enrollment :||32500 participants|
|Official Title:||"True Incidence of Hip Dislocation After Primary THA - a Nationwide Population Study"|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||October 1, 2019|
- Other: THA
Study participants have received a total hip arthroplasty due to arthritis. We do not make further intervention.
- Hip dislocation [ Time Frame: 2 years. ]The true incidence of hip dislocation calculated as proportion presented with 95% confidence intervals (CI).
- Age [ Time Frame: 2 years. ]Potential risk factor found by logistic regression analysis
- Sex [ Time Frame: 2 years. ]Potential risk factor found by logistic regression analysis
- Comorbidity [ Time Frame: 2 years. ]Potential risk factor found by logistic regression analysis
- Fixation of components [ Time Frame: 2 years. ]Potential risk factor found by logistic regression analysis
- Surgical approach [ Time Frame: 2 years. ]Potential risk factor found by logistic regression analysis
- Head diameter of prosthesis [ Time Frame: 2 years. ]Potential risk factor found by logistic regression analysis
- Time to dislocation [ Time Frame: 2 years. ]Time to first dislocation presented by Kaplan-Meier plot.
- Development in complication (dislocation) over time. [ Time Frame: 5 years. ]Incidence each year (2010-2014) calculated as proportion presented with 95% confidence intervals (CI) and compared statistically depending on distribution.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859791
|Hospital of South West Jutland|
|Esbjerg, Region Of Southern Denmark, Denmark, 6700|