Clinical Trials Directory

Trials / Unknown

UnknownNCT03859791

"True Incidence of Hip Dislocation After Primary THA - a Nationwide Population Study"

Status
Unknown
Phase
Study type
Observational
Enrollment
32,500 (actual)
Sponsor
University of Southern Denmark · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Accepted

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. 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

Conditions

Interventions

TypeNameDescription
OTHERTHAStudy participants have received a total hip arthroplasty due to arthritis. We do not make further intervention.

Timeline

Start date
2018-01-01
Primary completion
2019-06-01
Completion
2019-10-01
First posted
2019-03-01
Last updated
2019-03-01

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT03859791. Inclusion in this directory is not an endorsement.