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

National Taiwan University

Status: Not yet enrolling

Conditions: Pathological Fracture; Pathological Fracture, Left Femur; Pathological Fracture, Right Femur; Bone Metastases

Treatments: Device: Internal fixation with long intramedullary nails; Device: Internal fixation with short intramedullary nails

Study type: Interventional

Funder types: Other

Identifiers

NCT05969470

202301173DINA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Short intramedullary nails

Experimental group

Description:

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

Treatment:

Device: Internal fixation with short intramedullary nails

Long intramedullary nails

Active Comparator group

Description:

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

Treatment:

Device: Internal fixation with long intramedullary nails