Bone MetastasesNCT05969470
Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.
A study testing Internal fixation with short intramedullary nails and Internal fixation with long intramedullary nails in people with Bone Metastases and Pathological Fracture, run by National Taiwan University Hospital.
Trial 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: 1. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bone Metastases, Pathological Fracture, Pathological Fracture, Left Femur
- What is being tested?
- Internal fixation with short intramedullary nails and Internal fixation with long intramedullary nails
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
- 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.
Read the 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.
- Conditions
- Bone Metastases, Pathological Fracture, Pathological Fracture, Left Femur, Pathological Fracture, Right Femur
- Being tested
- Internal fixation with short intramedullary nails, Internal fixation with long intramedullary nails
- Keywords
- Long Intramedullary Nails, Short Intramedullary Nails, Bone Metastases, Pathological Fracture of Femur
- Medical subject headings
- Fractures, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal fixation with short intramedullary nailsDevice
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 nailsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Short intramedullary nails | Experimental | The patients receives bone fixation with short intramedullary nails for extremity metastases. Receives: Device: Internal fixation with short intramedullary nails |
| Long intramedullary nails | Active comparator | The patients receives bone fixation with long intramedullary nails for extremity metastases. Receives: Device: Internal fixation with long intramedullary nails |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Up to 1 year after the intervention
Secondary outcomes (5)
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.
Measured: At 1,3,6,12 months after the intervention
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.
Measured: 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
Measured: 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
Measured: Up to 1 year after the intervention
Cost-effectiveness analysis
Utility comparison using Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) questionnaire
Measured: Up to 2 year after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start31 Aug 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University Hospital Hsin-Chu Branch
- Responsible party
- Sponsor
- Investigators
- Hsiang Chieh Hsieh, MD, Study chair, Department of Orthopaedic Surgery, National Taiwan University Hospital, Hsin-Chu branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969470
- Sponsor's protocol ID
- 202301173DINA
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 23104043
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Efficacy of Long-nailed and Short-nailed Fixation for Proximal Femur Metastasis - a Non-inferior Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05969470
- Acronym / sponsor ID
- 202301173DINA
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University Hospital Hsin-Chu Branch
- Study start
- 31 Aug 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short intramedullary nails | Experimental | Device: Internal fixation with short intramedullary nailsThe patients receives bone fixation with short intramedullary nails for extremity metastases. |
| Long intramedullary nails | Active comparator | Device: Internal fixation with long intramedullary nailsThe patients receives bone fixation with long intramedullary nails for extremity metastases. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- The patient has a more appropriate treatment alternative to single intramedullary nail fixation as determined by the multidisciplinary decision, such as,
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal fixation with short intramedullary nailsIntramedullary 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. | Device | Short intramedullary nails |
| Internal fixation with long intramedullary nailsIntramedullary 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. | Device | Long intramedullary nails |
Primary outcome
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%.
5 secondary outcomes
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
Cardiopulmonary complication rate within 30 days after the intervention
Time frame: Up to 30 days after the intervention
Mortality rate at 1,3,6,12 months after the intervention
Time frame: At 1,3,6,12 months after the intervention
Percentage of of participants with distant femoral metastasis
Time frame: Up to 1 year after the intervention
Cost-effectiveness analysis
Time frame: Up to 2 year after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Results publication: PubMed 23104043Alvi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hsiang Chieh Hsieh, MD study chair
Department of Orthopaedic Surgery, National Taiwan University Hospital, Hsin-Chu branch
Questions about this trial
What is this clinical trial studying?
A study testing Internal fixation with short intramedullary nails and Internal fixation with long intramedullary nails in people with Bone Metastases and Pathological Fracture, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsiang Chieh Hsieh, MD (+886 972654075, D08528020@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation rate (time frame: Up to 1 year after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05969470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.