Arthroplasty, Metastatic Bone Tumor, Pathological Fracture
Conditions
Keywords
pathological, metastasis ,, cement reaction, long stem
Brief summary
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
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 .
Interventions
DEVICEfemoral stem in hip arthroplasty
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.
Sponsors
Ain Shams University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
only participants were blinded from treatment group.
Intervention model description
two comparative groups, standard and long femoral stem arthroplasty
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MSTS score | 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) | The Musculoskeletal Tumor Society (MSTS) scoring system is a disease-specific instrument to determine the physical and mental health for patients with extremity sarcoma |
| 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) | median and mean patient survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| visual analogue score | improvement of pain compared to preoperative status | VAS as a measure for pain relief |
| the Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status | implant specific ECOG as a measure of patient functional level compared at different time points(preoperative ,one month ,six months and one year postoperative) | is a simple measure of functional status. It has scores ranging from 0 to 5 |
| complications | will be reported during one year follow up | postoperative infection (superficial or deep),dislocation |
Countries
Egypt
Outcome results
None listed