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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Reoperation rate [Time frame: Up to 1 year after the intervention]

Secondary outcome measures (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 [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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 23104043

Identifiers

NCT: NCT05969470 · 202301173DINA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗