Comparative Study on Surgical Approaches for Elderly Femoral Neck Fractures

June 10, 2025 updated by: CHEN JIAN, Fujian Provincial Hospital

A Single Center Prospective Controlled Study of Direct Anterior Approach and Posterior Lateral Approach in the Treatment of Femoral Neck Fractures in Elderly Patients

A prospective controlled study was conducted to include patients who received hip replacement surgery for femoral neck fractures at the National Regional Trauma Center in Fujian Province from February 2023 to August 2024. Patients were randomly divided into the DAA group and the PLA group based on different surgical methods for a 3-month follow-up to compare the outcomes of the two groups. The main observation results include Harris hip joint function score (preoperative, postoperative 1 week, 1 month, 3 months), VAS pain score (preoperative, postoperative 1 week, 1 month, 3 months), and secondary observation results include surgical time, intraoperative blood loss, blood transfusion rate, difference in HB before and after surgery, difference in CK before and after surgery, perioperative complications, difference in length of both lower limbs after surgery, postoperative drainage volume, postoperative ICU occupancy rate, ICU length of stay, and total length of stay.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Provincial Hospital Trauma Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 80 years old;
  2. Diagnosed with unilateral femoral neck fracture through imaging examination;
  3. Patients who can tolerate surgery and agree to undergo surgery;
  4. Undergoing hemiarthroplasty (HA) for the first time;
  5. Able to walk independently and have intact cognitive function before the injury.

Exclusion Criteria:

  1. Bilateral femoral neck fractures;
  2. Patients with pathological fractures;
  3. Hip dysplasia, rheumatoid osteoarthritis, or other hip disorders;
  4. Patients with systemic or localized infections or inflammatory reactions at the surgical site;
  5. Patients with other lower limb fractures or severe injuries to other parts of the body; Patients with a history of previous hip surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DAA group
Patients with femoral neck fractures undergoing DAA-HA.
Procedure: Direct anterior approach hemiarthroplasty
Direct anterior approach hemiarthroplasty
Active Comparator: PLA group
Patients with femoral neck fractures undergoing PLA-HA.
Procedure: Posterior lateral approach hemiarthroplasty
Posterior lateral approach hemiarthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris hip joint function score
Time Frame: 1 week, 1 month, and 3 months after surgery
Scores range from 100 to 0, with 90-100 being excellent, 80-89 being good, 70-79 being acceptable, and ≤69 being poor.
1 week, 1 month, and 3 months after surgery
VAS pain score
Time Frame: 1 week, 1 month, and 3 months after surgery
The highest score is 10 and the lowest score is 0, with the following interpretations: 0 points indicating no pain; 1-3 points indicating mild pain with little impact on daily life; 4-6 points indicating moderate pain affecting daily life and sleep; 7-9 points indicating severe pain significantly affecting quality of life; and 10 points indicating unbearable, extreme pain.
1 week, 1 month, and 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 3 months after surgery
3 months after surgery
Operative time
Time Frame: Intraoperative
Intraoperative
Intraoperative bleeding volume
Time Frame: Intraoperative
Intraoperative
Intraoperative blood transfusion rate
Time Frame: Intraoperative
Intraoperative
Hemoglobin value
Time Frame: Preoperative and postoperative 1 day
Preoperative and postoperative 1 day
Blood creatine kinase value
Time Frame: Preoperative and postoperative 1 day
Preoperative and postoperative 1 day
Incidence of complications
Time Frame: Perioperative period
Perioperative period
Difference in length of both lower limbs
Time Frame: 3 days after surgery
3 days after surgery
Postoperative drainage volume
Time Frame: 24 hours after surgery
24 hours after surgery
Hospital stay
Time Frame: The duration (in days) from admission to discharge, estimated to be no more than 21 days at most.
The duration (in days) from admission to discharge, estimated to be no more than 21 days at most.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Provincial Hospital

Collaborators

Fujian Provincial Hospital Emergency Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

May 31, 2025

Study Completion (Actual)

May 31, 2025

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

January 7, 2025

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fujian Trauma Center

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Because of unit regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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