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NCT Number: NCT05969470

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

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.

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Key information

Conditions

Bone Metastases Fractures, Bone Fractures, Spontaneous Pathological Fracture Pathological Fracture, Left Femur Pathological Fracture, Right Femur Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internal fixation with short intramedullary nails

Device

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.

Internal fixation with long intramedullary nails

Device

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 outcomes

  1. Reoperation rate

    Time frame: Up to 1 year after the intervention

    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 outcomes

  1. 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

    Time frame: 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.

  2. Cardiopulmonary complication rate within 30 days after the intervention

    Time frame: Up to 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.

  3. Mortality rate at 1,3,6,12 months after the intervention

    Time frame: At 1,3,6,12 months after the intervention

    Percentage of demise at 1,3,6,12 months after the intervention

  4. Percentage of of participants with distant femoral metastasis

    Time frame: Up to 1 year after the intervention

    Newly formed metastatic lesions on the same limb distant to the operation site within 1 year after the intervention

  5. Cost-effectiveness analysis

    Time frame: Up to 2 year after the intervention

    Utility comparison using Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Hsiang Chieh Hsieh, MD

CONTACT

[email protected]

+886 972654075

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Taiwan University Hospital Hsin-Chu Branch
  • National Taiwan University Hospital, Yun-Lin Branch

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Aug 1, 2023
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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