Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04870151
• Other study ID #: 224045
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Sykehuset Innlandet HF
• Contact: Håvard Furunes, PhD
• Phone: 99041763
• Email: havardfurunes[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Procedure:
• Anterolateral approach
Cemented hemiarthroplasty using an anterolateral approach.
• Direct lateral approach
Cemented hemiarthroplasty using a direct lateral approach.

Locations

Country	Name	City	State
Norway	Innlandet Hospital Trust	Gjøvik	Innlandet

Sponsors (1)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 months
Secondary	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).	12 months
Secondary	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".	12 months
Secondary	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".	12 months
Secondary	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.	12 months
Secondary	Timed Up and Go (TUG)	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.	12 months
Secondary	Blood loss	The peroperative amount of blood loss (milliliters) is registered	During surgery
Secondary	Duration of surgery	The duration of the surgical procedure (minutes) is registered	During surgery
Secondary	Length of hospital stay	The length of hospital stay (days) is registered	12 months
Secondary	Adverse events	Adverse events such as perioperative complications, infections, dislocations and reoperations are registered	12 months
Secondary	Mortality	In patients who die within 12 months follow-up, the time of death is registered	12 months
Secondary	Cause of death	In patients who die within 12 months follow-up, the cause of death is registered	12 months