search
Back to results

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

Primary Purpose

Metastatic Bone Tumor, Pathological Fracture, Arthroplasty

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
femoral stem in hip arthroplasty
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Bone Tumor focused on measuring pathological, metastasis ,, cement reaction, long stem

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AinShams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

standard femoral stem

long femoral stem

Arm Description

standard length femoral stem arthroplasty applied for patients with proximal femoral metastasis either impending or pathological fracture

long femoral stem arthroplasty applied for patients with proximal femoral metastasis either impending or pathological fracture

Outcomes

Primary Outcome Measures

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
survival
median and mean patient survival

Secondary Outcome Measures

visual analogue score
VAS as a measure for pain relief
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
complications
postoperative infection (superficial or deep),dislocation

Full Information

First Posted
November 27, 2020
Last Updated
July 19, 2021
Sponsor
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT04660591
Brief Title
Length of the Femoral Stem in Arthroplasty Done for Patients With Proximal Femoral Metastatic Lesion
Official Title
Cemented Long Versus Standard Femoral Stem Arthroplasty for Proximal Femoral Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Bone Tumor, Pathological Fracture, Arthroplasty
Keywords
pathological, metastasis ,, cement reaction, long stem

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two comparative groups, standard and long femoral stem arthroplasty
Masking
Participant
Masking Description
only participants were blinded from treatment group.
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard femoral stem
Arm Type
Active Comparator
Arm Description
standard length femoral stem arthroplasty applied for patients with proximal femoral metastasis either impending or pathological fracture
Arm Title
long femoral stem
Arm Type
Active Comparator
Arm Description
long femoral stem arthroplasty applied for patients with proximal femoral metastasis either impending or pathological fracture
Intervention Type
Device
Intervention Name(s)
femoral stem in hip arthroplasty
Other Intervention Name(s)
cemented hip arthroplasty , hip replacement
Intervention Description
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.
Primary Outcome Measure Information:
Title
MSTS score
Description
The Musculoskeletal Tumor Society (MSTS) scoring system is a disease-specific instrument to determine the physical and mental health for patients with extremity sarcoma
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)
Title
survival
Description
median and mean patient 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)
Secondary Outcome Measure Information:
Title
visual analogue score
Description
VAS as a measure for pain relief
Time Frame
improvement of pain compared to preoperative status
Title
the Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status
Description
is a simple measure of functional status. It has scores ranging from 0 to 5
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)
Title
complications
Description
postoperative infection (superficial or deep),dislocation
Time Frame
will be reported during one year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
AinShams university
City
Cairo
State/Province
Abbasid
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
after publishing the study no limit regarding how long data will be shared
Citations:
PubMed Identifier
17062708
Citation
Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006 Oct 15;12(20 Pt 2):6243s-6249s. doi: 10.1158/1078-0432.CCR-06-0931.
Results Reference
background
PubMed Identifier
15292415
Citation
Schneiderbauer MM, von Knoch M, Schleck CD, Harmsen WS, Sim FH, Scully SP. Patient survival after hip arthroplasty for metastatic disease of the hip. J Bone Joint Surg Am. 2004 Aug;86(8):1684-9. doi: 10.2106/00004623-200408000-00011.
Results Reference
background
PubMed Identifier
26438441
Citation
Tsuda Y, Yasunaga H, Horiguchi H, Fushimi K, Kawano H, Tanaka S. Complications and Postoperative Mortality Rate After Surgery for Pathological Femur Fracture Related to Bone Metastasis: Analysis of a Nationwide Database. Ann Surg Oncol. 2016 Mar;23(3):801-10. doi: 10.1245/s10434-015-4881-9. Epub 2015 Oct 5.
Results Reference
background
PubMed Identifier
23361930
Citation
Xing Z, Moon BS, Satcher RL, Lin PP, Lewis VO. A long femoral stem is not always required in hip arthroplasty for patients with proximal femur metastases. Clin Orthop Relat Res. 2013 May;471(5):1622-7. doi: 10.1007/s11999-013-2790-4. Epub 2013 Jan 30.
Results Reference
background
PubMed Identifier
27052019
Citation
Peterson JR, Decilveo AP, O'Connor IT, Golub I, Wittig JC. What Are the Functional Results and Complications With Long Stem Hemiarthroplasty in Patients With Metastases to the Proximal Femur? Clin Orthop Relat Res. 2017 Mar;475(3):745-756. doi: 10.1007/s11999-016-4810-7.
Results Reference
result
PubMed Identifier
35152311
Citation
Abdelmonem IM, Azmy SI, El Masry AM, El Ghazawy AK, Kotb AS, Bassiony AA. Cemented long versus standard femoral stem in proximal femoral metastasis: a noninferiority single-blinded quasi-randomized clinical trial. Eur J Trauma Emerg Surg. 2022 Aug;48(4):2977-2985. doi: 10.1007/s00068-021-01875-x. Epub 2022 Feb 13.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs