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

Not Applicable

Completed

• Conditions: Metastatic Bone Tumor; Arthroplasty; Pathological Fracture
• Interventions: Device: femoral stem in hip arthroplasty

• Registration Number: NCT04660591
• Lead Sponsor: Ain Shams University

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 .

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-09
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• pathological or impending pathological pertrochanteric or neck femur fracture, regardless of the presence of distal femoral metastasis.

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Exclusion Criteria

• Previous arthroplasty in the same side. fractures or lesions involving the subtrochanteric region Pathological fracture due to metabolic disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
long femoral stem	femoral stem in hip arthroplasty	long femoral stem arthroplasty applied for patients with proximal femoral metastasis either impending or pathological fracture
standard femoral stem	femoral stem in hip arthroplasty	standard length femoral stem arthroplasty applied for patients with proximal femoral metastasis either impending or pathological fracture

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
complications	will be reported during one year follow up	postoperative infection (superficial or deep),dislocation
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

Trial Locations

Locations (1)

AinShams university; 🇪🇬 Cairo, Abbasid, Egypt