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

Primary Purpose

Fracture of Femur

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bipolar hemiarthroplasty , proximal femoral nail
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture of Femur focused on measuring BHA , PFN , HHS

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Medicine, Ain Shams universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

BHA group

PFN group

Arm Description

Patients will undergo Bipolar hemiarthroplasty operation

Patients will undergo cehphalo-medullary fixation (Proximal femoral nail)

Outcomes

Primary Outcome Measures

-Harris Hip Score(HHS)
- 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)
- 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

-Harris Hip Score(HHS)
- 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)
- 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.

Full Information

First Posted
November 13, 2021
Last Updated
November 24, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05134805
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
November 15, 2021 (Anticipated)
Study Completion Date
November 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Femur
Keywords
BHA , PFN , HHS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BHA group
Arm Type
Other
Arm Description
Patients will undergo Bipolar hemiarthroplasty operation
Arm Title
PFN group
Arm Type
Other
Arm Description
Patients will undergo cehphalo-medullary fixation (Proximal femoral nail)
Intervention Type
Procedure
Intervention Name(s)
Bipolar hemiarthroplasty , proximal femoral nail
Other Intervention Name(s)
prosthetic joint , fracture fixation
Intervention Description
Removal of head of femur , greater trochanter , and lesser trochanter and use bioplar hemiarthroplasty (BHA). Intra-medullary fixation of intertrchanteric femoral fracture by proximal femoral nail (PFN) Fixation of the fracture by using intramedullary nail(proximal femoral nail).
Primary Outcome Measure Information:
Title
-Harris Hip Score(HHS)
Description
- 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.
Time Frame
First 3 months post-operative
Title
-Mobility Score (MS)
Description
- 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.
Time Frame
First 3 months post-operative
Secondary Outcome Measure Information:
Title
-Harris Hip Score(HHS)
Description
- 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.
Time Frame
1 year follow up
Title
Mobility Score (MS)
Description
- 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.
Time Frame
1 year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Islam M Soliman, Master
Phone
2001007980973
Email
islam.soliman.0089@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Mohasseb, MD
Phone
2001223533433
Email
Mohasseb80@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed K Asal, MD
Organizational Affiliation
Ain shams university, Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine, Ain Shams university
City
Cairo
State/Province
Abbasia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Islam M Soliman, Master
Phone
2001007980973
Email
islam.soliman.0089@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed M Mohasseb, MD
Phone
2001223533433
Email
Mohasseb80@gmail.com

12. IPD Sharing Statement

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

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