Clinical trial NCT03382041: Carbon Fiber Implants
Official title: Intramedullary Nailing of Tibia Shaft Fractures With Carbon Fiber Implants Versus Titanium Nails: A Randomized Cohort Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tibial Shaft Fractures
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: CarboFix Orthopedics
First posted: 2017-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will compare intramedullary nailing( placing a rod in the tibia) of open and closed tibia shaft fractures with carbon fiber implant (tibial nail) versus titanium implant (tibial nail) in a Level I trauma setting.
Primary purpose: TREATMENT

Brief summary: The investigators will compare intramedullary nailing of open and closed tibia shaft fractures with carbon fiber implant versus titanium implant in a Level I trauma setting.

Detailed description: 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.

Eligibility criteria: 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

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Primary outcomes:
measure: The Number of Participants Identified With Fracture Healing
timeFrame: From baseline through 6 weeks.
measure: The Number of Participants Identified With Fracture Healing
timeFrame: From baseline through 3 months.
Secondary outcomes:
measure: Short Musculoskeletal Function Assessment Questionnaire (SMFA).
timeFrame: 6 months
measure: Short Musculoskeletal Function Assessment Questionnaire (SMFA) Score.
timeFrame: 6 months
measure: Short Musculoskeletal Function Assessment Questionnaire (SMFA).
timeFrame: 12 months.
measure: Short Musculoskeletal Function Assessment Questionnaire (SMFA) Score.
timeFrame: 12 months.
measure: Short Musculoskeletal Function Assessment Questionnaire (SMFA) Score.
timeFrame: 18 months.
measure: Veterans Rand Health Survey (VR-12)
timeFrame: 6 weeks.
measure: Veterans Rand Health Survey (VR-12)
timeFrame: 3 months
measure: Veterans Rand Health Survey (VR-12)
timeFrame: 6 months
measure: Veterans Rand Health Survey (VR-12)
timeFrame: 12 months
measure: Veterans Rand Health Survey (VR-12)
timeFrame: 18 months
measure: Veterans Rand Health Survey (VR-12)
timeFrame: 6 weeks
measure: Veterans Rand Health Survey (VR-12)
timeFrame: 3 months.
measure: Veterans Rand Health Survey (VR-12)
timeFrame: 12 months.
measure: Brief Pain Inventory (BPI)
timeFrame: 6 months.
measure: Veterans Rand Health Survey (VR-12) (Optional)
timeFrame: 18 months.
measure: Brief Pain Inventory (BPI)
timeFrame: 6 months.
measure: Brief Pain Inventory (BPI)
timeFrame: 6 months.
measure: Brief Pain Inventory (BPI)
timeFrame: 12 months.
measure: Brief Pain Inventory (BPI)
timeFrame: 12 months.
measure: Treatment Cost
timeFrame: Baseline to 18 months.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham (UAB)
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Clay A Spitler, MD
role: PRINCIPAL_INVESTIGATOR
References: