Comparative Study on Surgical Approaches for Elderly Femoral Neck Fractures

Not Applicable

Completed

• Conditions: Function; Pain

• Registration Number: NCT06760949
• Lead Sponsor: Fujian Provincial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Harris hip joint function score	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.
VAS pain score	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 Outcome Measures

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

Trial Locations

Locations (1)

Fujian Provincial Hospital Trauma Center; 🇨🇳 Fuzhou, Fujian, China