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

Hip Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03859791
• Other study ID #: 3-3013-2128/1
• Status: Active, not recruiting
• Start date: January 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: February 2019
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Specific components may be analyzed based on number.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32500
• Est. completion date: October 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Dislocation

Intervention

Other:
• THA
Study participants have received a total hip arthroplasty due to arthritis. We do not make further intervention.

Locations

Country	Name	City	State
Denmark	Hospital of South West Jutland	Esbjerg	Region Of Southern Denmark

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip dislocation	The true incidence of hip dislocation calculated as proportion presented with 95% confidence intervals (CI).	2 years.
Secondary	Age	Potential risk factor found by logistic regression analysis	2 years.
Secondary	Sex	Potential risk factor found by logistic regression analysis	2 years.
Secondary	Comorbidity	Potential risk factor found by logistic regression analysis	2 years.
Secondary	Fixation of components	Potential risk factor found by logistic regression analysis	2 years.
Secondary	Surgical approach	Potential risk factor found by logistic regression analysis	2 years.
Secondary	Head diameter of prosthesis	Potential risk factor found by logistic regression analysis	2 years.
Secondary	Time to dislocation	Time to first dislocation presented by Kaplan-Meier plot.	2 years.
Secondary	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.	5 years.