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

NCT04660591 | Completed FDA Device

• 1 other identifier: FMASU MD 277/ 2019
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 .

Conditions

Metastatic Bone Tumor; Pathological Fracture; Arthroplasty

Keywords

pathological, metastasis ,; cement reaction; long stem

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• visual analogue score

  improvement of pain compared to preoperative status

• the Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status

  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

  will be reported during one year follow up

Study Arms (2)

standard femoral stem

ACTIVE COMPARATOR

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

Device: femoral stem in hip arthroplasty

long femoral stem

ACTIVE COMPARATOR

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

Device: femoral stem in hip arthroplasty

Interventions

femoral stem in hip arthroplasty 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.

Also known as: cemented hip arthroplasty , hip replacement

long femoral stem; standard femoral stem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShams university

Cairo, Abbasid, Egypt

Location

Related Publications (6)

• 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.

  PMID: 17062708 BACKGROUND

• 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.

  PMID: 15292415 BACKGROUND

• 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.

  PMID: 26438441 BACKGROUND

• 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.

  PMID: 23361930 BACKGROUND

• 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.

  PMID: 27052019 RESULT

• 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.

  PMID: 35152311 DERIVED

MeSH Terms

Conditions

Bone Neoplasms; Fractures, Spontaneous; Neoplasm Metastasis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Fractures, Bone; Wounds and Injuries; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: only participants were blinded from treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: two comparative groups, standard and long femoral stem arthroplasty

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 9, 2020
• Study Start: November 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 30, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: after publishing the study no limit regarding how long data will be shared

Locations

EG (1)