A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures

Boston Medical Center (BMC)

Status

Completed

Conditions

Femoral Fractures

Treatments

Device: locking periarticular plate

Device: reamed, interlocking intramedullary nail

Study type

Interventional

Funder types

Other

Identifiers

NCT00429663

H-25934

Details and patient eligibility

About

This study looks at two (2) types of surgical treatments and hopes to answer the question, "which is the best way to surgically treat a distal femur fracture?" Both procedures being studied are standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.

Full description

The study is a randomized controlled multicenter trial in which individuals sustaining a fracture of the supracondylar (metaphyseal) region of the distal femur will be operatively managed by one of two strategies. The first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (Nail Group). The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (Plate Group). The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. To the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.

Enrollment

160 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Skeletally mature
Fracture of the metaphyseal distal femur with or without intra-articular extension and with or without a TKA
Fracture requiring operative treatment amenable to either IM nail or plate
Informed consent obtained
Patient is English speaking

Exclusion criteria

Fracture of the metaphyseal distal femur with intra-articular communition,
Fracture with vascular injury (Gustillo Type IIIC injury) requiring repair,
Pathological fracture,
Known metabolic bone disease,
Contralateral distal femur fractures (bilateral injury) or ipsilateral lower extremity injury that would compromise function of the knee
Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating
Symptomatic knee arthritis
Soft tissue injuries compromising either treatment method with nail or plate
Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures
Immunocompromised
Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired)
Current or impending incarceration
Unlikely to follow-up in surgeon's estimation