Outcomes of Hemiarthroplasty Versus Cephalo-medullary Fixation to Treat Unstable Intertrochanteric Femoral Fractures

Not Applicable

• Conditions: Fracture of Femur
• Interventions: Procedure: Bipolar hemiarthroplasty , proximal femoral nail

• Registration Number: NCT05134805
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2018-10-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-13
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Study First Submitted QC: 2021-11-24
• Last Update Submitted: 2021-11-24
• Study First Posted: 2021-11-26
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BHA group	Bipolar hemiarthroplasty , proximal femoral nail	Patients will undergo Bipolar hemiarthroplasty operation
PFN group	Bipolar hemiarthroplasty , proximal femoral nail	Patients will undergo cehphalo-medullary fixation (Proximal femoral nail)

Primary Outcome Measures

Name	Time	Method
-Harris Hip Score(HHS)	First 3 months post-operative	- Harris Hip Score(HHS) : scale from 70 to 100 (70-90) . The higher the HHS, the less dysfunction. A total score of \<70 is considered a poor result; 70-80 is considered fair, 80-90 is good, and 90-100 is an excellent result (1). No normative values are available.
-Mobility Score (MS)	First 3 months post-operative	- Mobility score(MS) : scale from 0 to 3 (0-3) 0 being good mobility and 3 being severely impaired mobility. The higher mobility score, the higher mobility impairment.

Secondary Outcome Measures

Name	Time	Method
-Harris Hip Score(HHS)	1 year follow up	- Harris hip score (HHS): scale from 70 to 100 (70-100). The higher the HHS, the less dysfunction. A total score of \<70 is considered a poor result; 70-80 is considered fair, 80-90 is good, and 90-100 is an excellent result (1). No normative values are available.
Mobility Score (MS)	1 year follow up	- Mobility score(MS) : scale from 0 to 3 (0-3) 0 being good mobility and 3 being severely impaired mobility. The higher mobility score, the higher mobility impairment.

Trial Locations

Locations (1)

Faculty of Medicine, Ain Shams university; 🇪🇬 Cairo, Abbasia, Egypt