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

NCT05969470 | Not Yet Recruiting FDA Device

• 1 other identifier: 202301173DINA
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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. 1.What is the rate of developing new distant metastasis of the operated extremities?
2. 2.Does treating extremities (impending) pathological fractures with long intramedullary nails have lower or similar reoperation rate than the short nails?
3. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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%.

  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

  At 1,3,6,12 months after the intervention

• Cardiopulmonary complication rate within 30 days after the intervention

  Up to 30 days after the intervention

• Mortality rate at 1,3,6,12 months after the intervention

  At 1,3,6,12 months after the intervention

• Percentage of of participants with distant femoral metastasis

  Up to 1 year after the intervention

• Cost-effectiveness analysis

  Up to 2 year after the intervention

Study Arms (2)

Short intramedullary nails

EXPERIMENTAL

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

Device: Internal fixation with short intramedullary nails

Long intramedullary nails

ACTIVE COMPARATOR

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

Device: Internal fixation with long intramedullary nails

Interventions

Internal fixation with short intramedullary nails 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.

Short intramedullary nails

Internal fixation with long intramedullary nails 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.

Long intramedullary nails

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital, Yun-Lin Branch: collaborator
• National Taiwan University Hospital Hsin-Chu Branch: collaborator

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Fractures, Spontaneous

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Hsiang Chieh Hsieh, MD

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

  STUDY CHAIR

Central Study Contacts

Hsiang Chieh Hsieh, MD

CONTACT

+886 972654075; D08528020@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: August 1, 2023
• Study Start: August 31, 2023
• Primary Completion: June 1, 2024
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share