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

• Conditions: Hip Dislocation

• Registration Number: NCT03859791
• Lead Sponsor: University of Southern Denmark

Brief 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

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-27
• Last Update Submitted: 2019-02-27
• Study First Posted: 2019-03-01
• Last Update Posted: 2019-03-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32500

Inclusion Criteria

• patients with the diagnosis "primary/idiopathic hip OA and inserted THA from 01.01.2010 - 31.12.2014.

Exclusion Criteria

• patients receiving a resurfacing hip arthroplasty and hip revisions
• patients with incomplete registry data
• patients with previous hip surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hip dislocation	2 years.	The true incidence of hip dislocation calculated as proportion presented with 95% confidence intervals (CI).

Secondary Outcome Measures

Name	Time	Method
Sex	2 years.	Potential risk factor found by logistic regression analysis
Development in complication (dislocation) over time.	5 years.	Incidence each year (2010-2014) calculated as proportion presented with 95% confidence intervals (CI) and compared statistically depending on distribution.
Head diameter of prosthesis	2 years.	Potential risk factor found by logistic regression analysis
Age	2 years.	Potential risk factor found by logistic regression analysis
Comorbidity	2 years.	Potential risk factor found by logistic regression analysis
Fixation of components	2 years.	Potential risk factor found by logistic regression analysis
Surgical approach	2 years.	Potential risk factor found by logistic regression analysis
Time to dislocation	2 years.	Time to first dislocation presented by Kaplan-Meier plot.

Trial Locations

Locations (1)

Hospital of South West Jutland; 🇩🇰 Esbjerg, Region Of Southern Denmark, Denmark