Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture

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

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

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures
• Intervention / Treatment: Procedure: Anterolateral approach; Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Håvard Furunes, PhD; Phone Number: 0047 99041763; Email: havardfurunes@gmail.com
• Study Contact Backup: Name: Audun D Bøhn, MD; Phone Number: 0047 90952322; Email: audun.bohn@gmail.com

Study Locations

• Norway
  • Innlandet
    • Gjøvik, Innlandet, Norway, 2819
      • Recruiting
      • Innlandet Hospital Trust
      • Contact: Håvard Furunes, PhD; Phone Number: 0047 99041763; Email: havardfurunes@gmail.com
      • Contact: Audun D Bøhn, MD; Phone Number: 0047 90952322; Email: audun.bohn@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anterolateral approach; The minimally invasive anterolateral approach (Watson-Jones approach) is performed with the patient in supine position. An oblique incision is made from just dorsal to the anterior superior iliac spine, and extended distally to the greater trochanter. After the fascia is incised, deep dissection continues in the plane between the tensor fasciae latae and the gluteus medius muscles. The joint capsule is exposed and opened. The femoral head and neck are resected and the femoral canal is reamed according to the preoperative plan. A femoral stem (Link Lubinus SPII) is fixed using bone cement (Heraeus Medical Palacos R+G pro) and connected to a bipolar femoral head (Zimmer Multipolar). After implantation of the prosthesis, the fascia, subcutis and skin is closed in separate layers with sutures.	Procedure: Anterolateral approach; Cemented hemiarthroplasty using an anterolateral approach.
Active Comparator: Direct lateral approach; The direct lateral approach (Hardinge approach) is performed with the patient in a lateral decubitus position. A straight or curved longitudinal incision is made over the greater trochanter, and the fascia is incised longitudinally. The anterior aspect of the gluteus medius and minimus muscles are separated from the greater trochanter. The joint capsule is exposed and opened. The femoral head and neck are resected and the femoral canal is reamed according to the preoperative plan. A femoral stem (Link Lubinus SPII) is fixed using bone cement (Heraeus Medical Palacos R+G pro) and connected to a bipolar femoral head (Zimmer Multipolar). After implantation of the prosthesis, the gluteus medius and minimus muscles are reinserted using osteosutures. The fascia, subcutis and skin is closed in separate layers with sutures.	Procedure: Direct lateral approach; Cemented hemiarthroplasty using a direct lateral approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Blood loss	The peroperative amount of blood loss (milliliters) is registered	During surgery
Duration of surgery	The duration of the surgical procedure (minutes) is registered	During surgery
Length of hospital stay	The length of hospital stay (days) is registered	12 months
Adverse events	Adverse events such as perioperative complications, infections, dislocations and reoperations are registered	12 months
Mortality	In patients who die within 12 months follow-up, the time of death is registered	12 months
Cause of death	In patients who die within 12 months follow-up, the cause of death is registered	12 months

Collaborators and Investigators

• Sponsor: Sykehuset Innlandet HF
• Investigators: Principal Investigator: Håvard Furunes, PhD, Sykehuset Innlandet HF

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Hemiarthroplasty; Surgical approach
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 224045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We have planned to use all the IPD only within the present study group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No