Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.

Compare the Efficacy of Long-nailed and Short-nailed Fixation for Proximal Femur Metastasis - a Non-inferior Randomized Controlled Trial

The goal of this interventional randomized controlled trial is to compare the clinical outcomes in treating extremities pathological fractures (fractures of limbs caused by metastatic tumors) or impending pathological fractures with short or long intramedullary nails. The main questions it aims to answer are:

1. What is the rate of developing new distant metastasis of the operated extremities?
2. Does treating extremities (impending) pathological fractures with long intramedullary nails have lower or similar reoperation rate than the short nails?
3. Are there any differences when comparing the surgical-related complication, functional outcomes and life quality assessment between treating extremities (impending) pathological fractures with long or short intramedullary nails.

Participants who meet surgical indication will be randomized into either the long or short intramedullary nail group after informed consent. The patient will receive bone fixation with the corresponding prosthesis.

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Metastases; Pathological Fracture; Pathological Fracture, Left Femur; Pathological Fracture, Right Femur
• Intervention / Treatment: Device: Internal fixation with short intramedullary nails; Device: Internal fixation with long intramedullary nails

Detailed Description

Participants will be randomized into either long or short intramedullary nail groups. Participants in the long intramedullary nail group will be fixed with a longer intramedullary nail (defined as greater than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures, while patients in the short intramedullary nail group will be fixed with a shorter intramedullary nail (defined as less than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures. Follow-up will be performed at 1, 3, 6, and 12 months after surgery to analyze the patient's function, blood sampling values, and imaging follow-up. The functional capacity will be evaluated by PROMIS questionnaire.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsiang Chieh Hsieh, MD; Phone Number: +886 972654075; Email: D08528020@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Femur (impending) pathological fracture that is suitable for intramedullary nail fixation as determined by the physician
• Patient is willing to participate in this clinical trial and cooperate with follow-up

Exclusion Criteria:

• The patient has a more appropriate treatment alternative to single intramedullary nail fixation as determined by the multidisciplinary decision, such as,

  • The metastatic lesions involved the femur head
  • The metastatic lesions involved the pelvis
  • The metastatic lesions compromised the greater or lesser trochanter to a certain extent that arthroplasty was indicated
  • The metastatic lesions involved/occurred more distal than the intertrochanteric line
• There are justified, clinically significant rationales that either long or short intramedullary nails be a more appropriate treatment during pre-operative assessment
• The patient has imaging-confirmed distant femoral metastases before treatment
• Patient has renal cell carcinoma or sarcoma
• Patient is unable to cooperate with follow-up or to understand the trial protocol
• Patient is unable to communicate in Chinese

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short intramedullary nails; The patients receives bone fixation with short intramedullary nails for extremity metastases.	Device: Internal fixation with short intramedullary nails; Intramedullary nailing is a method of internal fixation used to treat fractures. An intramedullary nail is a metal rod forced into the marrow canal of a bone to stabilize and align fractures. Participants in this group will be fixed with a shorter intramedullary nail (defined as defined as less than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures.
Active Comparator: Long intramedullary nails; The patients receives bone fixation with long intramedullary nails for extremity metastases.	Device: Internal fixation with long intramedullary nails; Intramedullary nailing is a method of internal fixation used to treat fractures. An intramedullary nail is a metal rod forced into the marrow canal of a bone to stabilize and align fractures. Participants in this group will be fixed with a longer intramedullary nail (defined as greater than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation rate	Percentage of patients receiving revision surgery within 1 year after the intervention. The primary outcome should be compared using non-inferior tests. The non-inferior margin was pre-specified at 25.4%.	Up to 1 year after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiopulmonary complication rate within 30 days after the intervention	Cardiopulmonary complication includes the following events developing within 30 days after the intervention: O2 desaturation, shock, embolic event, or coma and death.	Up to 30 days after the intervention
Mortality rate at 1,3,6,12 months after the intervention	Percentage of demise at 1,3,6,12 months after the intervention	At 1,3,6,12 months after the intervention
Percentage of of participants with distant femoral metastasis	Newly formed metastatic lesions on the same limb distant to the operation site within 1 year after the intervention	Up to 1 year after the intervention
Change from baseline in functional outcome on the Patient-Reported Outcomes Measurement Information System-29 scoring at 1,3,6,12 months after the intervention	The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluates physical, mental, and social health in adults and children. It's used to measure symptoms and other aspects of health status in a wide variety of chronic diseases. PROMIS-29 is a particular version of this system that covers multiple domains of health and function. It consists of 29 items in total, spanning seven domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference. Each domain has four questions, with the exception of the pain interference domain, which has five. Each question is scored from 1-5, the higher score indicates better function or quality of life. The sum of the PROMIS results in the raw score, which lies between 4 and 20. There's also a single question evaluating pain intensity, as assessed by pain intensity numeric rating scale.	At 1,3,6,12 months after the intervention
Cost-effectiveness analysis	Utility comparison using Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) questionnaire	Up to 2 year after the intervention

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Taiwan University Hospital Hsin-Chu Branch; National Taiwan University Hospital, Yun-Lin Branch
• Investigators: Study Chair: Hsiang Chieh Hsieh, MD, Department of Orthopaedic Surgery, National Taiwan University Hospital, Hsin-Chu branch

Publications and helpful links

General Publications

• Alvi HM, Damron TA. Prophylactic stabilization for bone metastases, myeloma, or lymphoma: do we need to protect the entire bone? Clin Orthop Relat Res. 2013 Mar;471(3):706-14. doi: 10.1007/s11999-012-2656-1. Epub 2012 Oct 27.

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Bone Metastases; Long Intramedullary Nails; Short Intramedullary Nails; Pathological Fracture of Femur
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Wounds and Injuries; Neoplastic Processes; Neoplasm Metastasis; Fractures, Bone; Fractures, Spontaneous
• Other Study ID Numbers: 202301173DINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes