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Clinical Trials/NCT04870151
NCT04870151
Active, Not Recruiting
N/A

Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture: A Randomised Study

Sykehuset Innlandet HF1 site in 1 country100 target enrollmentJune 1, 2021
ConditionsHip Fractures

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hip Fractures
Sponsor
Sykehuset Innlandet HF
Enrollment
100
Locations
1
Primary Endpoint
Harris Hip Score (HHS)
Status
Active, Not Recruiting
Last Updated
11 months ago

Overview

Brief Summary

Patients with dislocated hip fractures are randomised to cemented hemiarthroplasty with an anterolateral approach or a direct lateral approach.

Detailed Description

Dislocated intracapsular hip fractures are usually treated with cemented hemiarthroplasty. In Norway, a direct lateral approach is most often used, as recommended in national guidelines. In total hip arthroplasty, however, minimally invasive approaches are also commonly used, and may improve the clinical results, as compared to posterior or direct lateral approaches. The aims of the present study are to evaluate the effect of the minimally invasive anterolateral approach (Watson-Jones approach) compared to the direct lateral approach (Hardinge approach) to the hip joint in hemiarthroplasty after dislocated hip fractures. Patients with dislocated hip fractures who are fit for cemented hemiarthroplasty are randomised to surgery with an anterolateral approach or a direct lateral approach.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
December 31, 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • dislocated hip fracture.
  • planned cemented hemiarthroplasty.
  • able to walk, with or without walking aids, prior to the injury.

Exclusion Criteria

  • young and healthy patients with displaced hip fractures who are recommended total hip arthroplasty or open reduction / internal fixation of the fracture.
  • patients with severe comorbidity and high risk of cement-related complications who are recommended uncemented hemiarthroplasty (some, but not all, patients with ASA (American Society of Anesthesiologists) grade 4).
  • not able to give informed consent.

Outcomes

Primary Outcomes

Harris Hip Score (HHS)

Time Frame: 12 months

Harris Hip Score (HHS) is an outcome measure for hip-related symptoms. The score is based on both patient-reported information and clinical examination, and is administered by a qualified health care professional. It covers four domains: Pain, function, absence of deformity and range of motion. The score ranges from 0 (worst) to 100 (best).

Secondary Outcomes

  • EuroQol questionnaire (EQ-5D)(12 months)
  • Patient-reported limping(12 months)
  • Timed Up and Go (TUG)(12 months)
  • Adverse events(12 months)
  • Cause of death(12 months)
  • Blood loss(During surgery)
  • Duration of surgery(During surgery)
  • Patient-reported use of walking aid(12 months)
  • Trendelenburg test(12 months)
  • Length of hospital stay(12 months)
  • Mortality(12 months)

Study Sites (1)

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