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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859791
Recruitment Status : Active, not recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Lars Lykke Hermansen, 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.


Condition or disease Intervention/treatment
Hip Dislocation Other: THA

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

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Study Type : Observational
Actual Enrollment : 32500 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Hip dislocation [ Time Frame: 2 years. ]
    The true incidence of hip dislocation calculated as proportion presented with 95% confidence intervals (CI).


Secondary Outcome Measures :
  1. Age [ Time Frame: 2 years. ]
    Potential risk factor found by logistic regression analysis

  2. Sex [ Time Frame: 2 years. ]
    Potential risk factor found by logistic regression analysis

  3. Comorbidity [ Time Frame: 2 years. ]
    Potential risk factor found by logistic regression analysis

  4. Fixation of components [ Time Frame: 2 years. ]
    Potential risk factor found by logistic regression analysis

  5. Surgical approach [ Time Frame: 2 years. ]
    Potential risk factor found by logistic regression analysis

  6. Head diameter of prosthesis [ Time Frame: 2 years. ]
    Potential risk factor found by logistic regression analysis

  7. Time to dislocation [ Time Frame: 2 years. ]
    Time to first dislocation presented by Kaplan-Meier plot.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

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


Locations
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Denmark
Hospital of South West Jutland
Esbjerg, Region Of Southern Denmark, Denmark, 6700
Sponsors and Collaborators
University of Southern Denmark
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Responsible Party: Lars Lykke Hermansen, MD, Ph.d. Student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03859791    
Other Study ID Numbers: 3-3013-2128/1
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Dislocations
Hip Dislocation
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Hip Injuries