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NCT Number: NCT04870151

Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hip Fractures Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Innlandet Hospital Trust

Gjøvik, Innlandet, 2819, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anterolateral approach

Procedure

Cemented hemiarthroplasty using an anterolateral approach.

direct lateral approach

Procedure

Cemented hemiarthroplasty using a direct lateral approach.

Primary outcomes

  1. 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

  1. EuroQol questionnaire (EQ-5D)

    Time frame: 12 months

    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).

  2. Patient-reported limping

    Time frame: 12 months

    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".

  3. Patient-reported use of walking aid

    Time frame: 12 months

    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".

  4. Trendelenburg test

    Time frame: 12 months

    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.

  5. Timed Up and Go (TUG)

    Time frame: 12 months

    The Timed Up and Go (TUG) test is a performance-based measure of functional mobility that was initially developed to identify mobility and balance impairments in older adults.

    The patients start in a seated position, walk 3 meters, turn around, walk back to the chair and sit down. The time starts when the patient is commanded to start and stops when the patient is seated.

  6. Blood loss

    Time frame: During surgery

    The peroperative amount of blood loss (milliliters) is registered

  7. Duration of surgery

    Time frame: During surgery

    The duration of the surgical procedure (minutes) is registered

  8. Length of hospital stay

    Time frame: 12 months

    The length of hospital stay (days) is registered

  9. Adverse events

    Time frame: 12 months

    Adverse events such as perioperative complications, infections, dislocations and reoperations are registered

  10. Mortality

    Time frame: 12 months

    In patients who die within 12 months follow-up, the time of death is registered

  11. Cause of death

    Time frame: 12 months

    In patients who die within 12 months follow-up, the cause of death is registered

Sponsors and collaborators

Lead sponsor

Sykehuset Innlandet HF

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
May 3, 2021
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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