Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture

N/AActive Not RecruitingNCT04870151

Sykehuset Innlandet HF100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Hip Fractures

Interventions

Anterolateral approachPROCEDURE

Cemented hemiarthroplasty using an anterolateral approach.

Direct lateral approachPROCEDURE

Cemented hemiarthroplasty using a direct lateral approach.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Innlandet Hospital Trust

Gjøvik, Innlandet, Norway

Outcomes

Primary Outcomes

Harris Hip Score (HHS)

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).

Time frame: 12 months

Secondary Outcomes

EuroQol questionnaire (EQ-5D)

Quality of life is measured by the EuroQol questionnaire (EQ-5D). EQ-5D is a validated generic health-related quality-of-life instrument. It consists of two parts: EQ-5D descriptive part and EQ-5D visual analogue scale. The descriptive part includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three possible answers ("no problems", "some problems", and "major problems"). EQ-5D VAS is a visual analogue scale of self-related overall health, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

Time frame: 12 months

Patient-reported limping

Patient-reported limping is a sub-score of the Harris Hip Score. The patients describe their limping as (1) "none", (2) "slight", (3) "moderate" or (4) "severe or unable to walk".

Time frame: 12 months

Patient-reported use of walking aid

Patient-reported use of walking aid is a sub-score of the Harris Hip Score. The patients describe their use of walking aid as (1) "none", (2) "cane/walking stick for long walks", (3) "cane/walking stick most of the time", (4) "one crutch", (5) "two canes/walking sticks" or (6) "two crutches or unable to walk".

Time frame: 12 months

Trendelenburg test

Trendelenburg test is a clinical test for the integrity of hip abductor muscle function. The test is positive when the patient is unable to maintain the pelvis horizontal to the floor when standing on one leg.

Data from ClinicalTrials.gov

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