Length of the Femoral Stem in Arthroplasty Done for Patients With Proximal Femoral Metastatic Lesion

Study Overview
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Brief Summary
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Proximal femoral metastatic disease is a common cause of morbidity and mortality in cancer patients.protecting the entire femur using long nail or long femoral stem was hypothesized to prevent future fracture.However we believe that long stem isn't always necessary and won't decrease the complication rate.noting it's increased complication rate in this high risk patient category .

Detailed Description
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Skeletal metastasis is the third most common site of cancer metastasis after the lungs and liver, almost all patients with metastatic prostate cancer will have bone metastasis. And about 90% of patients dying from breast cancer has skeletal metastasis. The most common site to which cancer metastasize to long bones is the proximal femur, especially to the intertrochanteric region and femoral neck, contributing to increasing incidence of impending and pathologic fractures of this site.(8) Recent advances in cancer treatment increased the longevity of patients, with subsequent increase in morbidity of metastatic disease and increased number of patients living longer with this condition . To date, long femoral stem is most frequently used in cases of pathological and impending proximal femoral fractures. Its use is believed to add more stability and prophylactically protect the entire femur from newly developed distal lesions. However, long stems has more operative time, more cardiopulmonary complications and are more technically demanding compared to standard femoral stems arthroplasty.(5) Recent retrospective study by Xing et al reported comparable outcomes between standard, medium and long stems and concluded that the routine use of long stems is unjustified.Another recent report by Joel et al investigated the use of long femoral stem in 22 limbs, they reported no hardware failure with no cases of intraoperative cardiopulmonary complications, however they recommended larger comparative trials with rigorous methods to investigate the functional outcomes and complications of long femoral stems in proximal femoral metastatic lesions. In face of the potential advantages in this patient population, the goal of this study is to investigate the use of standard length femoral stems and its results compared to long femoral stems in proximal femoral metastasis .

Official Title
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Cemented Long Versus Standard Femoral Stem Arthroplasty for Proximal Femoral Metastasis

Conditions
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Metastatic Bone Tumor, Pathological Fracture, Arthroplasty

Intervention / Treatment
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* Device: femoral stem in hip arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pathological or impending pathological pertrochanteric or neck femur fracture, regardless of the presence of distal femoral metastasis. Exclusion Criteria: Previous arthroplasty in the same side. fractures or lesions involving the subtrochanteric region Pathological fracture due to metabolic disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two comparative groups, standard and long femoral stem arthroplasty
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard femoral stem<br>standard length femoral stem arthroplasty applied for patients with proximal femoral metastasis either impending or pathological fracture | Device: femoral stem in hip arthroplasty<br>* using lateral approach to the hip we will compare the effect of femoral stem length on the oncological and functional outcomes in patients with proximal femoral metastasis.hip arthroplasty is a surgical procedure that involves changing the head of the femur (the ball) with or without replacing the articular surface of the acetabulum (the socket ).and replacing it with metal head based on a stem covered with cement to fix it to the bone of the femur.<br>* Other names: cemented hip arthroplasty , hip replacement;|
| Active Comparator: long femoral stem<br>long femoral stem arthroplasty applied for patients with proximal femoral metastasis either impending or pathological fracture | Device: femoral stem in hip arthroplasty<br>* using lateral approach to the hip we will compare the effect of femoral stem length on the oncological and functional outcomes in patients with proximal femoral metastasis.hip arthroplasty is a surgical procedure that involves changing the head of the femur (the ball) with or without replacing the articular surface of the acetabulum (the socket ).and replacing it with metal head based on a stem covered with cement to fix it to the bone of the femur.<br>* Other names: cemented hip arthroplasty , hip replacement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSTS score | The Musculoskeletal Tumor Society (MSTS) scoring system is a disease-specific instrument to determine the physical and mental health for patients with extremity sarcoma | Implant-specific differences in postoperative functional outcomes will be determined and compared throughout the study period at different time points(preoperative, postoperative at one month, six months and one year) | 
| survival | median and mean patient survival | Implant-specific differences in survival will be determined and compared throughout the study period at different time points(preoperative, postoperative at one month, six months and one year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue score | VAS as a measure for pain relief | improvement of pain compared to preoperative status | 
| the Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status | is a simple measure of functional status. It has scores ranging from 0 to 5 | implant specific ECOG as a measure of patient functional level compared at different time points(preoperative ,one month ,six months and one year postoperative) | 
| complications | postoperative infection (superficial or deep),dislocation | will be reported during one year follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pathological, metastasis ,, cement reaction, long stem