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

Functional Outcomes of Hemiarthroplasty Versus Cephalo-medullary Fixation in the Treatment of Unstable Intertrochanteric Femoral Fractures

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05134805
Enrollment
30
Registered
2021-11-26
Start date
2018-10-01
Completion date
2021-11-15
Last updated
2021-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture of Femur

Keywords

BHA , PFN , HHS

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.

Interventions

PROCEDUREBipolar hemiarthroplasty , proximal femoral nail

* 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).

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
-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

MeasureTime frameDescription
-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.

Countries

Egypt

Contacts

Primary ContactIslam M Soliman, Master
islam.soliman.0089@gmail.com2001007980973
Backup ContactAhmed M Mohasseb, MD
Mohasseb80@gmail.com2001223533433

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026