Recruiting

Resection & Reconstruction vs. Internal Fixation

Sponsor:

Michelle Ghert, MD

Code:

NCT06863129

Conditions

Metastatic Bone Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Internal Fixation

Resection and reconstruction

Study Details

Brief summary:

The goal of this clinical trial is to find out if removing and replacing part of the hip bone works better than using metal hardware to stabilize the bone in patients whose cancer has spread to the hip. The main questions are:

1. Does removing and replacing part of the bone work better than just stabilizing it with metal hardware?
2. Does removing and replacing the bone help reduce problems like cancer coming back or the metal hardware breaking?

Researchers will compare two treatments: using metal rods and plates to stabilize the bone (internal fixation) versus removing part of the bone and possibly replacing the hip joint (resection and reconstruction) to see if the second option causes fewer problems.

Participants will:

  • Be randomly assigned to one of two groups (internal fixation or resection and reconstruction).
  • Have one of the two surgeries based on which group they're in.
  • Go to follow-up appointments with the study doctor at 2 weeks, 6 weeks, 4 months, 6 months, 9 months, and 12 months after surgery.

Conditions

Metastatic Bone Disease

Study ID

NCT06863129

Start date

Feb 1, 2025

Status verified date

Jul, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Life expectancy of at least 6 months
  • Lesions in the proximal femur (femoral neck, intertrochanteric region, subtrochanteric region, and combinations thereof)
  • Low or intermediate risk for perioperative morbidity and/or mortality
  • No more than 75% and no less than 25% bone loss
  • Mutual (patient and physician) decision to perform surgical management of an impending or realized pathologic fracture due to MBD of the proximal has been made.

Exclusion Criteria:

  • Lesions isolated to the femoral neck
  • Lesion with any femoral head involvement
  • High risk for perioperative morbidity and/or mortality
  • Multidisciplinary decision that resection of the entire lesion would be indicated

Study Design

Enrollment

334 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Resection and Reconstruction

If a participant is randomized to the Resection and Reconstruction treatment arm, a proximal femoral resection or hip arthroplasty will be carried out as per standard surgical practice. The type of endoprosthesis used for reconstruction will be at the treating surgeon's discretion. Acetabular reconstruction (if any), the surgical approach, and the intra-operative use of cement and other adjuvants for disease control will also be at the discretion of the treating surgeon.

active comparator: Internal Fixation

If the participant is randomized to the Internal Fixation treatment arm, the surgery will involve the stabilization of the remaining bone with either an intramedullary nail, plate or screw fixation. All standard surgical principles of stable internal fixation will be followed. The type of fixation, the surgical approach, and the intra-operative use of cement and other adjuvants for disease control will be at the treating surgeon's discretion.

Interventions

Internal Fixation

Internal Fixation

Resection and reconstruction

Resection and reconstruction

Primary outcome measure

  • Mortality at 12 months [ Time Frame: From enrollment to one year follow-up post surgery. ]
  • Physical function [ Time Frame: From enrollment to one year follow-up post surgery. ]
  • Number of days at home [ Time Frame: From enrollment to one year follow-up post surgery. ]

Central Contacts and Locations

Central contacts

Olivia Virag, MA

905- 521-2100viragoe@mcmaster.ca

Hadia Farrukh

905- 521-2100farrukhh@mcmaster.ca

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Steven Thorpe

303-724-5375steven.thorpe@cuanschutz.edu

Veronica Butler

VERONICA.BUTLER@CUANSCHUTZ.EDU

Principal Investigator:

Steven Thorpe

Parkview Packnett Family Cancer Institute

Recruiting

Fort Wayne, Indiana, United States, 46845

Contacts

Ashley Romine

260-266-9156ashley.romine@parkview.com

Principal Investigator:

Chris Johnson

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Samir Sabharwal, MD

513-584-1000sabharsr@ucmail.uc.edu

Principal Investigator:

Samir Sabharwal

Oregon Health and Science University Hospital

Recruiting

Portland, Oregon, United States, 97239

Contacts

Rebecca Smith

503-494-2963smithreb@ohsu.edu

Principal Investigator:

Kenneth Gundle

More Information

Sponsor

Michelle Ghert, MD

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michelle Ghert, MD on 2026-07-08.