A Single Center Prospective Controlled Study of Direct Anterior Approach and Posterior Lateral Approach in the Treatment of Femoral Neck Fractures in Elderly Patients
Phase: NA
Conditions: Function, Pain
Sponsor: 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
Team leader unit: Fujian Provincial Hospital
Project leader: Xu Wei
Responsible department: emergency surgery department
Contact number: 13959116868
Participants: Fujian Provincial Hospital
Study years: February 2023 - August 2024

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scenario summary
project name
A single-center prospective controlled study of a direct anterior
versus posterolateral approach for femoral neck fractures in very
elderly patients
purpose of
research
To evaluate the clinical efficacy of a direct anterior approach (DAA)
versus posterolateral approach (PLA) hemiarthroplasty for femoral
neck fractures in advanced elderly patients.
research
design
A prospective controlled study including the patients treated for
femoral neck fracture between February 2023 and 20 August 2024
were randomly ized into DAA and PLA groups according to different
surgical methods for a 3-month follow-up to compare the outcomes of
the two groups. Main observations include Harris hip function score
(preoperative, 1 week, January, march), VAS pain score
(preoperative, 1 week, January, march), secondary observations
include operation time, intraoperative bleeding, blood transfusion
rate, HB difference before and after surgery, CK before and after
surgery, perioperative complications, postoperative lower limb length
difference, postoperative discharge, postoperative ICU occupancy
rate, ICU stay and total hospital stay.
Total number
of cases
43 Cases
Case
①Age over 80 years old; ②confirmed unilateral femoral neck
fracture by imaging examination; ③tolerated surgery and consent to

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selection
surgery; ④initial HA; independent walking and complete cognitive
function before ⑤injury.
①Bilateral femoral neck fracture; ②patients with pathological
fracture; ③with hip dysplasia and rheumatoid osteoarthritis; ④with
systemic or surgical site local infection or inflammatory reaction; ⑤
with other lower limb fractures or severe injuries to other parts of the
body; ⑥with previous history of hip surgery.
statistical
method
In this study, the statistical analysis was performed using the SPSS
27.0 statistical software.
The study
period
February 2023
August, 2024

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1. research background
Femoral neck fracture is a common fracture type in the elderly, and its
high disability and mortality make it a fatal killer to the life and health of the
elderly. Surgery is the main treatment of femoral neck fracture in the elderly
patients. Traditional femoral neck fracture in elderly patients mostly adopts
the posterolateral approach (PLA) hemihip arthroplasty under spinal
anesthesia, and the direct anterior approach (DAA) emerging in recent years
can also be used as an option for the treatment of femoral neck fracture in
elderly patients. However, due to the long learning curve of DAA, the
operation is difficult, and whether this operation can be used as an effective
way of femoral neck fracture in elderly patients still needs further study.
2. purpose of research
1. Primary objective: To evaluate the clinical efficacy of direct anterior
approach (DAA) and posterolateral approach (PLA) hemiarthroplasty in the
treatment of femoral neck fractures in elderly patients.
2. Secondary purpose: To provide some reference for the clinical
treatment of femoral neck fracture in the elderly.
3. Type and principle of the study design
1. Study design
In a prospective controlled study, patients who underwent femoral neck
replacement for femoral neck fracture between February 2023 and 20 August
2024 were randomly divided into DAA and PLA groups according to different
surgical methods for a 3-month follow-up to compare the outcomes of the two
groups.
4. Case selection
1. Inclusion criteria

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①Age over 80 years old; ②confirmed unilateral femoral neck fracture by
imaging examination; ③tolerated surgery and consent to surgery; ④initial
HA; independent walking and complete cognitive function before ⑤injury.
2. Exclusion criteria
①Bilateral femoral neck fracture; ②patients with pathological fracture;
③with hip dysplasia and rheumatoid osteoarthritis; ④with systemic or
surgical site local infection or inflammatory reaction; ⑤with other lower limb
fractures or severe injuries to other parts of the body; ⑥with previous history
of hip surgery.
5. observation item
General information: gender, age (age), height (cm), weight (kg),
comorbidity, American Association of Anesthesiologists (American Society of
Anesthesiologists, ASA) classification.
Fracture
related
data:
fracture
side
division,
fracture
Garden
classification and anatomical site classification, Pauwels angle (°).
Main indicators: Harris hip function score and VAS pain score before, 1
week, 1 month and 3 months after surgery.
Laboratory indicators: hemoglobin value (hemoglobin, HB) (g / L),
creatine kinase value (creatine kinase, CK) (U / L) before and after surgery,
and the difference was recorded and calculated.
Surgical index: operation time (min), intraoperative blood loss (ml), and
intraoperative blood transfusion rate (%).
Perioperative
complications:
Surgery-related
complications
include
periprosthetic fracture, dislocation, surgical site infection and LFCN injury,
while
systemic
complications
include
lower
limb
venous
thrombosis,
pulmonary infection, death, etc.
Other indicators: postoperative length difference of both lower limbs,

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postoperative discharge, postoperative transfer to ICU, ICU length of stay
(days), total length of stay (days), mortality rate (%).
Six, data security monitoring
The clinical study will develop a corresponding data safety monitoring
plan according to the risk size. All adverse events are detailed documented,
Properhandled and tracked until properly resolved or stable, Report serious
adverse events and unexpected events to the Ethics committee, competent
authorities, sponsor and drug regulatory department in time; A cumulative
review of all adverse events was performed periodically by the principal
investigator, Hold investigator meetings when necessary to assess the risks
and benefits of the study; Double-blind tests may be performed for
emergency unblinding when necessary, To ensure the subjects safety and
rights and interests; Studies greater than the minimum risk will schedule an
independent data monitor to monitor the study data, The high-risk study will
establish an independent data safety monitoring board to monitor the
accumulated safety data and efficacy data, To make recommendations on
whether the study continues.
VII. Statistical treatment
Statistical analysis of the data was performed using the IBM SPSS
Statistics 27 software. Measurement data are expressed as x ± s, compared
by t-test or Mann-Whitney U test according to whether the data conform to the
normal distribution; count data are compared by x² test or Fisher exact
probability method according to the conditions. A P <0.05 was considered as
a statistically significant difference.
VIII. Ethics of clinical research
Clinical research will follow the provisions of the Declaration of Helsinki.

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The clinical study was performed before EC approval of the study protocol.
Before each subject is included in the study, the investigator has the
responsibility to present the subject or his agent about the purpose and
procedures and possible risks to the study and sign a written informed
consent to inform the subject that they have the right to withdraw from the
study at any time, and the informed consent shall be retained as a clinical
study document for future reference. Personal privacy and data confidentiality
will be protected during the study.
Ix. Research progress
2023.02-2023.10 Preliminary data collection
2023.11-2024.08 Completed data collection, data collation and statistical
analysis
2024.09-2025.06 Papers writing and submission
X. Participants
surname
and
personal
name
Professional title /
major
assignment
Chen Jian
Graduate student in
emergency medicine
Data collection and
data analysis
Hong-ru
CAI
associate chief
physician
Data collection and
data analysis
Xu Wei
botanic physician
Arc
ata collection and
data analysis

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