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Completed

NCT Number: NCT06760949

Comparative Study on Surgical Approaches for Elderly Femoral Neck Fractures

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.

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Key information

Conditions

Function Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Provincial Hospital Trauma Center

Fuzhou, Fujian, 350001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Direct anterior approach hemiarthroplasty

Procedure

Direct anterior approach hemiarthroplasty

Posterior lateral approach hemiarthroplasty

Procedure

Posterior lateral approach hemiarthroplasty

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Operative time

    Time frame: Intraoperative

  2. Intraoperative bleeding volume

    Time frame: Intraoperative

  3. Intraoperative blood transfusion rate

    Time frame: Intraoperative

  4. Hemoglobin value

    Time frame: Preoperative and postoperative 1 day

  5. Blood creatine kinase value

    Time frame: Preoperative and postoperative 1 day

  6. Incidence of complications

    Time frame: Perioperative period

  7. Difference in length of both lower limbs

    Time frame: 3 days after surgery

  8. Postoperative drainage volume

    Time frame: 24 hours after surgery

  9. Hospital stay

    Time frame: The duration (in days) from admission to discharge, estimated to be no more than 21 days at most.

  10. Mortality

    Time frame: 3 months after surgery

Sponsors and collaborators

Lead sponsor

Fujian Provincial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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