An interventional study of Bipolar hemiarthroplasty , proximal femoral nail in Fracture of Femur, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-26.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 30 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients will undergo Bipolar hemiarthroplasty operation
Procedure: Bipolar hemiarthroplasty , proximal femoral nail
Patients will undergo cehphalo-medullary fixation (Proximal femoral nail)
Procedure: Bipolar 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).
Also known as: prosthetic joint , fracture fixation
-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.
Time frame: First 3 months post-operative
-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.
Time frame: First 3 months post-operative
-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.
Time frame: 1 year follow up
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.
Time frame: 1 year follow up
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Ain Shams University