Carbon Fiber Implants

The tibia (long bone in the leg) bears most of the body weight and is the most commonly
fractured long bone in the body. According to the National Center for Health Statistics;
tibia, fibula and ankle fractures account for an annual sum of 581,000 fractures. Of all long
bone fractures, the tibia is the most common site for non -union(failure to heal).

For many years, the standard practice in the treatment of fractures of the tibia shaft and
other long bones has been intramedullary nailing (placing rod in the bone)using titanium or
stainless steel implants( tibial nails).

More recently however, orthopaedic surgeons have found an alternative to the standard carbon
fiber implants (tibial nails), especially in the prophylactic reinforcement of bones
susceptible to pathological fractures following metastatic tumors. The new carbon fiber has
also been used in the treatment of tibial non-union (non- healing bone); which has shown
satisfactory outcomes. A clear advantage over titanium implants (tibial nails) is the carbon
fiber's radiolucent (ability to see through the implant on x-ray) property. This allows for
improved visualization of early healing and the reduction of fracture segments (i.e. fracture
alignment) without the typical radiopaque (inability to see through the implant on x-ray)
density and artifact found with metals on x-ray, MRI or CT Scans. The early visualization of
callus formation8(healing) may therefore serve as a good prognostic predictor of successful
union.

Thus orthopaedic trauma patients, especially in cases of polytrauma may heal faster; attain
earlier weight bearing status, and independence, decrease rehabilitation center stays and
advance recovery with possible quicker return to work. These benefits have economic
significance in reducing direct costs to patients and their families as well as to the
healthcare system. Use of carbon fiber implants (tibial nails) seems to hold the promise of a
shorter recovery time with better functional outcome than with more rigid titanium implants
(tibial nails). This is due to the carbon fiber implants(tibial nails) elasticity
(flexibility) which is close to that of bone, preventing excessive rigidity and possible non-
union (non -healing bone).

Intramedullary nails have continued to evolve, beginning with stainless steel implants and
progressing to titanium. The titanium nail has been used over several years and the carbon
fiber is a newer material and is now used by several institutions for treatment of tibial
shaft fractures. There are no studies that directly compare the two nails in a prospective
manner.

The standard of care for treatment of tibial shaft fractures is the use of an intramedullary
(rod inside the bone) implant. Both implants perform the same function but are made of
different materials. Current treatment of tibia fractures at The University of Alabama at
Birmingham (UAB) utilizes both titanium and carbon fiber implants.

Inclusion Criteria:

- i. Skeletal maturity (patients included will be 18 - 64 years, i.e. whose
epiphyseal/growth plates are closed) ii. Arbeitsgemeinschaft ur
Osteosynthesefragen/Orthpaedica Trauma Association (AO/OTA) Fracture class 42; open
and closed tibia shaft fracture (Gustilo-Anderson Types I II, and III; Tscherne closed
types 0, I, 2 and 3), Tscherne open types I and II.

iii. Fractures amenable to intramedullary nailing (placing a rod within the bone) iv.
Fracture gaps less than 2 cm due to bone loss v. In cases of bilateral tibial fractures the
investigators would include both if they meet inclusion criteria..

vi. Patient's informed consent or that of a legally acceptable representative

Exclusion Criteria:

i. Subjects currently enrolled in one or more clinical studies ii. Skeletal immaturity
(i.e. 17 years and younger) iii. Fractures planned for non-operative management iv. Complex
intra-articular involvement of tibia plateau or distal tibia v. Pathologic fractures
(fractures secondary to disease) vi. Concomitant ipsilateral tibia shaft fractures with
complex pilon and/or plateau fractures requiring fixation vii. Patients already treated or
in re-treatment viii. Tibia already infected as diagnosed by the attending physician ix.
Patients likely to be lost before completing adequate follow-up, such as prisoners or
planned out-of-state (and other likely problems in the investigator's judgment, with
maintaining follow-up visit schedule) x. Patient is intellectually challenged or has a
severe psychiatric condition xi. Patient is incompetent in the English Language xii.
Patient is non-ambulatory before injury or as a consequence of polytrauma xiii. Inability
to obtain patient's informed consent and/or that of a legally acceptable representative