AzTrials
AzTrials

Metastatic Bone TumorNCT04660591

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

A study testing femoral stem in hip arthroplasty in people with Metastatic Bone Tumor and Pathological Fracture, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
femoral stem in hip arthroplasty
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteEgypt
Study dates
1 Nov 2019to 30 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • AinShams university

    Cairo, Abbasid

Other trials in Egypt

About this study

Official title: 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 .

Read the 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 .

Being tested
femoral stem in hip arthroplasty
Keywords
pathological, metastasis ,, cement reaction, long stem
Medical subject headings
Bone Neoplasms, Fractures, Spontaneous, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • femoral stem in hip arthroplastyDevice

    Also called cemented hip arthroplasty , hip replacement

    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.

Study groups in NCT04660591
Study groupRoleWhat they receive
standard femoral stemActive comparatorstandard length femoral stem arthroplasty applied for patients with proximal femoral metastasis either impending or pathological fracture
Receives: Device: femoral stem in hip arthroplasty
long femoral stemActive comparatorlong femoral stem arthroplasty applied for patients with proximal femoral metastasis either impending or pathological fracture
Receives: Device: femoral stem in hip arthroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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)

  2. survival

    median and mean patient survival

    Measured: 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 outcomes (3)

  1. visual analogue score

    VAS as a measure for pain relief

    Measured: improvement of pain compared to preoperative status

  2. 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

    Measured: implant specific ECOG as a measure of patient functional level compared at different time points(preoperative ,one month ,six months and one year postoperative)

  3. complications

    postoperative infection (superficial or deep),dislocation

    Measured: will be reported during one year follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start1 Nov 2019
  3. Primary completion1 May 2021
  4. Study completion30 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
two comparative groups, standard and long femoral stem arthroplasty
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04660591
Sponsor's protocol ID
FMASU MD 277/ 2019
Status last verified
Jul 2021
First submitted
27 Nov 2020
Last updated
20 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 17062708

  • 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.

    PubMed 15292415

  • 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.

    PubMed 26438441

  • 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.

    PubMed 23361930

  • 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.

    PubMed 27052019

  • 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.

    PubMed 35152311

Questions about this trial

What is this clinical trial studying?

A study testing femoral stem in hip arthroplasty in people with Metastatic Bone Tumor and Pathological Fracture, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04660591, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in