search
Back to results

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

Primary Purpose

Bone Metastases, Pathological Fracture, Pathological Fracture, Left Femur

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internal fixation with short intramedullary nails
Internal fixation with long intramedullary nails
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Metastases focused on measuring Long Intramedullary Nails, Short Intramedullary Nails, Bone Metastases, Pathological Fracture of Femur

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Short intramedullary nails

    Long intramedullary nails

    Arm Description

    The patients receives bone fixation with short intramedullary nails for extremity metastases.

    The patients receives bone fixation with long intramedullary nails for extremity metastases.

    Outcomes

    Primary Outcome Measures

    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%.

    Secondary Outcome Measures

    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.
    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.
    Mortality rate at 1,3,6,12 months after the intervention
    Percentage of demise 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
    Cost-effectiveness analysis
    Utility comparison using Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) questionnaire

    Full Information

    First Posted
    May 9, 2023
    Last Updated
    August 15, 2023
    Sponsor
    National Taiwan University Hospital
    Collaborators
    National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University Hospital Hsin-Chu Branch
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05969470
    Brief Title
    Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.
    Official Title
    Compare the Efficacy of Long-nailed and Short-nailed Fixation for Proximal Femur Metastasis - a Non-inferior Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 31, 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    June 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital
    Collaborators
    National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University Hospital Hsin-Chu Branch

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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: What is the rate of developing new distant metastasis of the operated extremities? Does treating extremities (impending) pathological fractures with long intramedullary nails have lower or similar reoperation rate than the short nails? 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Metastases, Pathological Fracture, Pathological Fracture, Left Femur, Pathological Fracture, Right Femur
    Keywords
    Long Intramedullary Nails, Short Intramedullary Nails, Bone Metastases, Pathological Fracture of Femur

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Short intramedullary nails
    Arm Type
    Experimental
    Arm Description
    The patients receives bone fixation with short intramedullary nails for extremity metastases.
    Arm Title
    Long intramedullary nails
    Arm Type
    Active Comparator
    Arm Description
    The patients receives bone fixation with long intramedullary nails for extremity metastases.
    Intervention Type
    Device
    Intervention Name(s)
    Internal fixation with short intramedullary nails
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Internal fixation with long intramedullary nails
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Reoperation rate
    Description
    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%.
    Time Frame
    Up to 1 year after the intervention
    Secondary Outcome Measure Information:
    Title
    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
    Description
    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.
    Time Frame
    At 1,3,6,12 months after the intervention
    Title
    Cardiopulmonary complication rate within 30 days after the intervention
    Description
    Cardiopulmonary complication includes the following events developing within 30 days after the intervention: O2 desaturation, shock, embolic event, or coma and death.
    Time Frame
    Up to 30 days after the intervention
    Title
    Mortality rate at 1,3,6,12 months after the intervention
    Description
    Percentage of demise at 1,3,6,12 months after the intervention
    Time Frame
    At 1,3,6,12 months after the intervention
    Title
    Percentage of of participants with distant femoral metastasis
    Description
    Newly formed metastatic lesions on the same limb distant to the operation site within 1 year after the intervention
    Time Frame
    Up to 1 year after the intervention
    Title
    Cost-effectiveness analysis
    Description
    Utility comparison using Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) questionnaire
    Time Frame
    Up to 2 year after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hsiang Chieh Hsieh, MD
    Phone
    +886 972654075
    Email
    D08528020@ntu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hsiang Chieh Hsieh, MD
    Organizational Affiliation
    Department of Orthopaedic Surgery, National Taiwan University Hospital, Hsin-Chu branch
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23104043
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs