Clinical trial NCT06760949: Comparative Study on Surgical Approaches for Elderly Femoral Neck Fractures
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Function
Pain
Keywords: femoral neck fractures
direct anterior approach
hemiarthroplasty
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
Collaborators: name: Fujian Provincial Hospital Emergency Center
First posted: 2025-01-07
Enrollment: 102
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Harris hip joint function score
timeFrame: 1 week, 1 month, and 3 months after surgery
measure: VAS pain score
timeFrame: 1 week, 1 month, and 3 months after surgery
Secondary outcomes:
measure: Operative time
timeFrame: Intraoperative
measure: Intraoperative bleeding volume
timeFrame: Intraoperative
measure: Intraoperative blood transfusion rate
timeFrame: Intraoperative
measure: Hemoglobin value
timeFrame: Preoperative and postoperative 1 day
measure: Blood creatine kinase value
timeFrame: Preoperative and postoperative 1 day
measure: Incidence of complications
timeFrame: Perioperative period
measure: Difference in length of both lower limbs
timeFrame: 3 days after surgery
measure: Postoperative drainage volume
timeFrame: 24 hours after surgery
measure: Hospital stay
timeFrame: The duration (in days) from admission to discharge, estimated to be no more than 21 days at most.
measure: Mortality
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital Trauma Center
state: Fujian
Study officials:
References:
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