Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture

NCT04870151 | Active Not Recruiting

• 1 other identifier: 224045
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Fractures

Keywords

Surgical approach; Hemiarthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• EuroQol questionnaire (EQ-5D)

  12 months

• Patient-reported limping

  12 months

• Patient-reported use of walking aid

  12 months

• Trendelenburg test

  12 months

• Timed Up and Go (TUG)

  12 months

Study Arms (2)

Anterolateral approach

EXPERIMENTAL

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

Direct lateral approach

ACTIVE COMPARATOR

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

Interventions

Anterolateral approach PROCEDURE

Cemented hemiarthroplasty using an anterolateral approach.

Anterolateral approach

Direct lateral approach PROCEDURE

Cemented hemiarthroplasty using a direct lateral approach.

Direct lateral approach

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead

Study Sites (1)

Innlandet Hospital Trust

Gjøvik, Innlandet, 2819, Norway

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Håvard Furunes, PhD

  Sykehuset Innlandet HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors are instructed to assess the outcomes before they log in to the patients' journal. Thereby, they will not have information of the treatment allocation at the time of outcomes assessment. Also, they will not ask the patients to undress or in any other way examine the surgical site, as the location of the scar tissue may disclose the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: May 3, 2021
• Study Start: June 1, 2021
• Primary Completion: May 19, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)