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

NCT ID: NCT04660591

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-05-30

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 .

Conditions

Metastatic Bone Tumor; Pathological Fracture; Arthroplasty

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard femoral stem

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

Group Type: ACTIVE_COMPARATOR

femoral stem in hip arthroplasty

Intervention Type: DEVICE

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.

long femoral stem

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

Group Type: ACTIVE_COMPARATOR

femoral stem in hip arthroplasty

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

cemented hip arthroplasty , hip replacement

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Mahmoud Abdelmonem

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AinShams university

Cairo, Abbasid, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 17062708 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15292415 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26438441 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23361930 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27052019 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35152311 (View on PubMed)

Other Identifiers

FMASU MD 277/ 2019

Identifier Type: -

Identifier Source: org_study_id