Comparison of Direct Anterior Approach vs. Lateral Hemiarthroplasty for Femoral Neck Fracture Repair

NCT05173155 | Unknown DMC

• 1 other identifier: 20210516-01H
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Recent research has demonstrated that a hemiarthroplasty (replacement of half the joint) has lower rates of post-surgical complications than a total hip arthroplasty does. However, surgeons tend to vary in their approach to hemiarthroplasties. The lateral approach, which involves making an incision at the side of the patient's hip, requires surgeons to cut through the muscle to access the hip, which has been associated with greater muscle damage and slower rates of recovery. On the other hand, the direct anterior approach does not require the cutting of the patient's muscle and is therefore associated with minimal muscle damage and faster rates of recovery. This study will aim to assess the impact of the surgical approach (Direct Anterior Approach vs. Lateral approach) during hemiarthroplasty on patients' short-term mobility, quality of life, function, pain, and safety parameters.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Short-term mobility

  The primary outcome measure will be mobility, assessed using the Short Physical Performance Battery (SPPB) test at post-operative day six or at discharge (4). This outcome assessed at this timeframe has been shown to be predictive of long-term function.

  six days post-op

Secondary Outcomes (4)

• EuroQol 5

  2-weeks post-op

• Visual Analogue Scale

  2-weeks post-op

• Opioid Use

  2-weeks post-op

• Barthel 20 Index

  ost-operative day six or at discharge, day 14, and week 6

Study Arms (2)

Direct anterior approach for hemiarthroplasty

EXPERIMENTAL

Patients in this arm will receive a hemiarthroplasty using the direct anterior approach (DAA)

Procedure: surgical approach

Lateral approach for hemiarthroplasty

EXPERIMENTAL

Patients in this arm will receive a hemiarthroplasty using the lateral approach

Procedure: surgical approach

Interventions

surgical approach PROCEDURE

Comparison of short-term outcomes (patient mobility, quality of life, function, pain, and safety parameters) for the direct anterior approach and Lateral approach for hemiarthroplasty for patients who have experienced a femoral-neck hip fracture.

Direct anterior approach for hemiarthroplasty; Lateral approach for hemiarthroplasty

Eligibility Criteria

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

You may qualify if:

• Any patient undergoing a hemiarthroplasty for a femoral neck fracture;
• Patients capable of reading, writing and signing an informed consent form

You may not qualify if:

• Patients under the age of 18

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, k1h 8l6, Canada

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will either receive a hemiarthroplasty in the direct anterior approach or the lateral approach.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 29, 2021
• Study Start: May 30, 2022
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

CA (1)