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

Arthroplasty Clinical Trial

Official title:

Cemented Long Versus Standard Femoral Stem Arthroplasty for Proximal Femoral Metastasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04660591
• Other study ID #: FMASU MD 277/ 2019
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: July 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 increased complication rate in this high risk patient category .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 30, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty
• Metastatic Bone Tumor
• Pathological Fracture

Intervention

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.

Locations

Country	Name	City	State
Egypt	AinShams university	Cairo	Abbasid

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. Review. — View 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/s1 — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Primary	survival	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	visual analogue score	VAS as a measure for pain relief	improvement of pain compared to preoperative status
Secondary	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	implant specific ECOG as a measure of patient functional level compared at different time points(preoperative ,one month ,six months and one year postoperative)
Secondary	complications	postoperative infection (superficial or deep),dislocation	will be reported during one year follow up