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

July 19, 2021 updated by: Ibrahim Mahmoud Abdelmonem, Ain Shams University

Cemented Long Versus Standard Femoral Stem Arthroplasty for Proximal Femoral Metastasis

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbasid
      • Cairo, Abbasid, Egypt
        • Ainshams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard femoral stem
standard length femoral stem arthroplasty applied for patients with proximal femoral metastasis either impending or pathological fracture
Device: femoral 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.
Other Names:
  • cemented hip arthroplasty , hip replacement
Active Comparator: long femoral stem
long femoral stem arthroplasty applied for patients with proximal femoral metastasis either impending or pathological fracture
Device: femoral 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.
Other Names:
  • cemented hip arthroplasty , hip replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MSTS score
Time Frame: 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
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
Time Frame: 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
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
Time Frame: improvement of pain compared to preoperative status
VAS as a measure for pain relief
improvement of pain compared to preoperative status
the Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status
Time Frame: 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
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
Time Frame: will be reported during one year follow up
postoperative infection (superficial or deep),dislocation
will be reported during one year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

November 27, 2020

First Submitted That Met QC Criteria

December 8, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD 277/ 2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

after publishing the study no limit regarding how long data will be shared

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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