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Comparative Study on Surgical Approaches for Elderly Femoral Neck Fractures

F

Fujian Provincial Hospital

Status

Completed

Conditions

Function
Pain

Treatments

Procedure: Posterior lateral approach hemiarthroplasty
Procedure: Direct anterior approach hemiarthroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT06760949
Fujian Trauma Center

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

All

Ages

80+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 2 patient groups

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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