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

NCT ID: NCT05969470

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2027-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short intramedullary nails

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

Group Type: EXPERIMENTAL

Internal fixation with short intramedullary nails

Intervention Type: 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.

Long intramedullary nails

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

Group Type: ACTIVE_COMPARATOR

Internal fixation with long intramedullary nails

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital, Yun-Lin Branch

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsiang Chieh Hsieh, MD

Role: STUDY_CHAIR

Department of Orthopaedic Surgery, National Taiwan University Hospital, Hsin-Chu branch

Central Contacts

Hsiang Chieh Hsieh, MD

Role: CONTACT

D08528020@ntu.edu.tw

+886 972654075

References

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.

Reference Type: RESULT

PMID: 23104043 (View on PubMed)

Other Identifiers

202301173DINA

Identifier Type: -

Identifier Source: org_study_id