A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures

Boston Medical Center (BMC)

Status

Completed

Conditions

Tibial Fractures

Treatments

Device: locking periarticular plate

Device: reamed, interlocking intramedullary nail

Study type

Interventional

Funder types

Other

Identifiers

NCT00429585

H-25923

Details and patient eligibility

About

This study looks at two types of surgical treatments and hopes to answer the question: which is the best way to surgically treat a proximal tibia 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 multicenter randomized controlled trial in which individuals sustaining a fracture of the proximal metaphysis of the tibia 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

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Skeletally mature,
Extra-articular fracture of the proximal tibia extending into the metaphyseal with or without intra-articular extension not requiring open reduction with complete anteroposterior (AP) and lateral radiographs,
Major fracture line not closer than 4cm from the proximal tibial articular surface
Fracture requiring operative treatment amenable to either IM nail or plate
Surgeon agreed to randomize patient
Informed consent obtained
Patient is English speaking

Exclusion criteria

Tibial shaft fractures not amenable to intramedullary nailing (i.e.fracture is less than 4 cm from joint surface),
Fracture of the proximal tibia with intraarticular extension requiring open reduction,
Known metabolic bone disease
Separate displaced tibial tubercle fragment,
Soft tissue injuries compromising treatment method with nail,plate or both.
Fractures with vascular injury (Gustillo Type IIIC injury) requiring repair,
Compartment syndrome of the leg diagnosed preoperatively,
Pathological fractures,
Retained hardware or existing deformity in the affected limb that would complicate IM nailing,plating or both,
Symptomatic knee arthritis.
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.