Clinical trial NCT05134805: Outcomes of Hemiarthroplasty Versus Cephalo-medullary Fixation to Treat Unstable Intertrochanteric Femoral Fractures
Official title: Functional Outcomes of Hemiarthroplasty Versus Cephalo-medullary Fixation in the Treatment of Unstable Intertrochanteric Femoral Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture of Femur
Keywords: BHA , PFN , HHS
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing functional outcomes of hemiarthroplasty (prosthetic joint) versus cephalo-medullary fixation ( proximal femoral intramedullary nail) in the treatment of unstable intertrochanteric femoral fractures (proximal femur fractures) in elderly people above 60 years old.

Detailed description: The intertrochanteric femoral fractures incidence rate has increased through the last years because of increasing life expectancy, leading to more morbidity and mortality rates . Unstable fracture pattern occurs due to age increase and bone quality decrease. Unstable intertrochanteric femoral fractures (ITFF) are considered about 40-45% of hip fractures in elderly people . Of note, 55% of these fractures had unstable patterns . The main objective of treatment is to restore the patients to their preoperative daily activities and medical conditions .

Therefore, the surgical treatment aims to return the patient to his pre-fracture level of activity to ensure that the patient moves as soon as possible to prevent complications due to immobility which can lead to death.

In an unstable fracture pattern which is characterized by decreased bone quality, it is of great importance to providing efficient and proper treatment . A lot of treatment modalities had been used in the treatment of this fracture pattern such as PFN, unipolar hemiarthroplasty, BHA, and dynamic hip screw (DHS) . On the other hand, it is difficult to perform stable fixation owing to osteoporotic bone quality.

The treatment aims to restore the patient's ambulation and decrease medical complications and technical failure. By using either BHA or PFN methods, patients can return to pre-injury levels decreasing complications induced by prolonged immobilization or implant failure .

The primary objective of the current study is to compare functional outcomes of unstable ITFF managed by PFN or BHA among cases with ages more than 60 years old. The second main objective is to compare intraoperative and postoperative in both groups.

Eligibility criteria: Inclusion Criteria:

* Patient over 60 years old.
* Unstable intertrochanteric femoral fractures

Exclusion Criteria:

* patient with age less than 60 years old
* Hip osteoarthritis
* Pathological fractures
* Bilateral fractures
* Metabolic bone disease
* Multiple trauma

Primary outcomes:
measure: -Harris Hip Score(HHS)
timeFrame: First 3 months post-operative
measure: -Mobility Score (MS)
timeFrame: First 3 months post-operative
Secondary outcomes:
measure: -Harris Hip Score(HHS)
timeFrame: 1 year follow up
measure: Mobility Score (MS)
timeFrame: 1 year follow up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ain Shams university
state: Abbasia
Study officials:
affiliation: Ain shams university, Faculty of Medicine
name: Mohamed K Asal, MD
role: STUDY_DIRECTOR
References:
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