Clinical trial NCT05969470: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital, Yun-Lin Branch
name: National Taiwan University Hospital Hsin-Chu Branch
First posted: 2023-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

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

Primary outcomes:
measure: Reoperation rate
timeFrame: Up to 1 year after the intervention
Secondary outcomes:
measure: 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
timeFrame: At 1,3,6,12 months after the intervention
measure: Cardiopulmonary complication rate within 30 days after the intervention
timeFrame: Up to 30 days after the intervention
measure: Mortality rate at 1,3,6,12 months after the intervention
timeFrame: At 1,3,6,12 months after the intervention
measure: Percentage of of participants with distant femoral metastasis
timeFrame: Up to 1 year after the intervention
measure: Cost-effectiveness analysis
timeFrame: Up to 2 year after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Department of Orthopaedic Surgery, National Taiwan University Hospital, Hsin-Chu branch
name: Hsiang Chieh Hsieh, MD
role: STUDY_CHAIR
References:
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.