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

NCT03859791 | Unknown DMC

• 1 other identifier: 3-3013-2128/1
• Study Type: observational
• Target: 32,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Dislocation

Outcome Measures

Primary Outcomes (1)

• Hip dislocation

  The true incidence of hip dislocation calculated as proportion presented with 95% confidence intervals (CI).

  2 years.

Secondary Outcomes (8)

• Age

  2 years.

• Sex

  2 years.

• Comorbidity

  2 years.

• Fixation of components

  2 years.

• Surgical approach

  2 years.

Interventions

THA OTHER

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Hospital of South West Jutland

Esbjerg, Region Syddanmark, 6700, Denmark

Location

MeSH Terms

Conditions

Hip Dislocation

Interventions

Tacrine

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.d. Student

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 1, 2019
• Study Start: January 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: October 1, 2019
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)