Tibial Shaft FracturesNCT03382041
Carbon Fiber Implants
A study testing Carbon Fiber Implant and Titanium Implant in people with Tibial Shaft Fractures, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tibial Shaft Fractures
- What is being tested?
- Carbon Fiber Implant and Titanium Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2017to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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..
- Patient's informed consent or that of a legally acceptable representative
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35233
About this study
Official title: Intramedullary Nailing of Tibia Shaft Fractures With Carbon Fiber Implants Versus Titanium Nails: A Randomized Cohort Study
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.
Read the 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.
- Conditions
- Tibial Shaft Fractures
- Being tested
- Carbon Fiber Implant, Titanium Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Fiber ImplantDevice
A cannulated rod, made of long carbon fiber reinforced polymer, with interlocking holes at its proximal and distal ends. The Nail provides for a slight bend. A Tantalum radiopaque marker along the Nail longitudinal axis provides for its visualization under fluoroscopy. The Nail proximal end is marked by a tantalum marker.
Titanium ImplantDevice
An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail or Küntscher nail (without proximal or distal fixation), is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body
| Study group | Role | What they receive |
|---|---|---|
| Carbon Fiber Implant | Experimental | There is an alternative to the standard treatment, which is 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. Receives: Device: Carbon Fiber Implant |
| Titanium Implant | Active comparator | The standard of practice in the treatment of fractures of the tibial shaft and other long bones has been the intramedullary nailing using titanium or stainless steel implants. Receives: Device: Titanium Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Identified With Fracture Healing
Will assess radiographically the fracture healing for patients treated with Carbon Fiber and Titanium Implants.
Measured: From baseline through 6 weeks.
The Number of Participants Identified With Fracture Healing
Will assess radiographically the fracture healing for patients treated with Carbon Fiber and Titanium Implants.
Measured: From baseline through 3 months.
Secondary outcomes (20)
Short Musculoskeletal Function Assessment Questionnaire (SMFA).
The SMFA will be administered to patients at 6 months following injury. The scores of dysfunction are calculated by summing up the responses to the items and then transforming the scores according to the formula. This transformation formula gives the final scores which ranged from 0-100. The higher scores indicate poorer function.
Measured: 6 months
Short Musculoskeletal Function Assessment Questionnaire (SMFA) Score.
Patient reported levels of function and satisfaction with the fixation method and overall treatment. The SMFA will be administered to patients at 6 months following injury. The scores of bother are calculated by summing up the responses to the items and then transforming the scores according to the formula. This transformation formula gives the final scores which ranged from 0-100. The higher scores indicate poorer function.
Measured: 6 months
Short Musculoskeletal Function Assessment Questionnaire (SMFA).
Patient reported levels of function and satisfaction with the fixation method and overall treatment. The Short Form Musculoskeletal Assessment (SMFA) will be administered to patients at 12 months following injury. The scores of dysfunction are calculated by summing up the responses to the items and then transforming the scores according to the formula. This transformation formula gives the final scores which ranged from 0-100. The higher scores indicate poorer function.
Measured: 12 months.
Short Musculoskeletal Function Assessment Questionnaire (SMFA) Score.
Patient reported levels of function and satisfaction with the fixation method and overall treatment. The Short Form Musculoskeletal Assessment (SMFA) will be administered to patients at 12 months following injury. The scores of bother are calculated by summing up the responses to the items and then transforming the scores according to the formula. This transformation formula gives the final scores which ranged from 0-100. The higher scores indicate poorer function.
Measured: 12 months.
Short Musculoskeletal Function Assessment Questionnaire (SMFA) Score.
Patient reported levels of function and satisfaction with the fixation method and overall treatment. The Short Form Musculoskeletal Assessment (SMFA) will be administered to patients at 18 months following injury. The scores of the dysfunction and bother indices are calculated by summing up the responses to the items and then transforming the scores according to the formula. This transformation formula gives the final scores which ranged from 0-100. The higher scores indicate poorer function.
Measured: 18 months.
Veterans Rand Health Survey (VR-12)
The Veterans Rand 12 Item Health Survey is a multipurpose, self-administered generic measure health status. It was developed to measure health-related quality of life, estimate disease burden and compare disease-specific benchmarks across populations. The VR-12 items measure eight health domains: general health perceptions, physical functioning and role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. The instrument produces a physical health and mental health. Assesses how much physical health has changed over a period of time. The VR instruments use a nine-point ordinal response choices for four items in the VR-12. These answers then contribute to the scales for role limitations due to physical and emotional problems and the physical and mental summary scores.
Measured: 6 weeks.
Veterans Rand Health Survey (VR-12)
The Veterans Rand 12 Item Health Survey is a multipurpose, self-administered generic measure health status. It was developed to measure health-related quality of life, estimate disease burden and compare disease-specific benchmarks across populations. The VR-12 items measure 8 health domains: general health perceptions, physical functioning and role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. Assesses how much physical health has changed over a period of time. The VR instruments use a nine-point ordinal response choices for four items in the VR-12. These answers then contribute to the scales for role limitations due to physical and emotional problems and the physical and mental summary scores. The score is based on the US average, which is 50. The score is a T-score which has a mean and standard deviation (mean of 50 has standard deviation of 10). The higher the score the healthier the individual.
Measured: 3 months
Veterans Rand Health Survey (VR-12)
The Veterans Rand 12 Item Health Survey is a multipurpose, self-administered generic measure health status. It was developed to measure health-related quality of life, estimate disease burden and compare disease-specific benchmarks across populations. The VR-12 items measure eight health domains: general health perceptions, physical functioning and role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. Assesses how much physical health has changed over a period of time. The VR instruments use a nine-point ordinal response choices for four items in the VR-12. These answers then contribute to the scales for role limitations due to physical and emotional problems and the physical and mental summary scores. The score is based on the US average, which is 50. The score is a T-score which has a mean and standard deviation (mean of 50 has standard deviation of 10). The higher the score the healthier the individual.
Measured: 6 months
Veterans Rand Health Survey (VR-12)
The Veterans Rand 12 Item Health Survey is a multipurpose, self-administered generic measure health status. It was developed to measure health-related quality of life, estimate disease burden and compare disease-specific benchmarks across populations. The VR-12 items measure eight health domains: general health perceptions, physical functioning and role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. Assesses how much physical health has changed over a period of time. The VR instruments use a nine-point ordinal response choices for four items in the VR-12. These answers then contribute to the scales for role limitations due to physical and emotional problems and the physical and mental summary scores. The score is based on the US average, which is 50. The score is a T-score which has a mean and standard deviation (mean of 50 has standard deviation of 10). The higher the score the healthier the individual.
Measured: 12 months
Veterans Rand Health Survey (VR-12)
The Veterans Rand 12 Item Health Survey is a multipurpose, self-administered generic measure health status. It was developed to measure health-related quality of life, estimate disease burden and compare disease-specific benchmarks across populations. The VR-12 items measure eight health domains: general health perceptions, physical functioning and role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. Assesses how much physical health has changed over a period of time. The VR instruments use a nine-point ordinal response choices for four items in the VR-12. These answers then contribute to the scales for role limitations due to physical and emotional problems and the physical and mental summary scores. The score is based on the US average, which is 50. The score is a T-score which has a mean and standard deviation (mean of 50 has standard deviation of 10). The higher the score the healthier the individual.
Measured: 18 months
Veterans Rand Health Survey (VR-12)
The Veterans Rand 12 Item Health Survey is a multipurpose, self-administered generic measure health status. It was developed to measure health-related quality of life, estimate disease burden and compare disease-specific benchmarks across populations. The VR-12 items measure eight health domains: general health perceptions, physical functioning and role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. Assesses how much physical health has changed over a period of time. The VR instruments use a nine-point ordinal response choices for four items in the VR-12. These answers then contribute to the scales for role limitations due to physical and emotional problems and the physical and mental summary scores. The score is based on the US average, which is 50. The score is a T-score which has a mean and standard deviation (mean of 50 has standard deviation of 10). The higher the score the healthier the individual.
Measured: 6 weeks
Veterans Rand Health Survey (VR-12)
The Veterans Rand 12 Item Health Survey is a multipurpose, self-administered generic measure health status. It was developed to measure health-related quality of life, estimate disease burden and compare disease-specific benchmarks across populations. The VR-12 items measure eight health domains: general health perceptions, physical functioning and role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. Assesses how much physical health has changed over a period of time. The VR instruments use a nine-point ordinal response choices for four items in the VR-12. These answers then contribute to the scales for role limitations due to physical and emotional problems and the physical and mental summary scores. The score is based on the US average, which is 50. The score is a T-score which has a mean and standard deviation (mean of 50 has standard deviation of 10). The higher the score the healthier the individual.
Measured: 3 months.
Veterans Rand Health Survey (VR-12)
The Veterans Rand 12 Item Health Survey is a multipurpose, self-administered generic measure health status. It was developed to measure health-related quality of life, estimate disease burden and compare disease-specific benchmarks across populations. The VR-12 items measure eight health domains: general health perceptions, physical functioning and role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. Assesses how much physical health has changed over a period of time. The VR instruments use a nine-point ordinal response choices for four items in the VR-12. These answers then contribute to the scales for role limitations due to physical and emotional problems and the physical and mental summary scores. The score is based on the US average, which is 50. The score is a T-score which has a mean and standard deviation (mean of 50 has standard deviation of 10). The higher the score the healthier the individual.
Measured: 12 months.
Brief Pain Inventory (BPI)
The BPI is a widely used, 15-item measure of pain intensity and interference with daily life. The questionnaire assesses three key pain domains: pain intensity, pain interference, and efficacy of pain treatments or medications. The BPI rapidly assesses the functional severity of pain and its impact on function. The scale range is 0 to 10. A lower score means pain does not interfere with normal activities of daily living.
Measured: 6 months.
Veterans Rand Health Survey (VR-12) (Optional)
The Veterans Rand 12 Item Health Survey is a multipurpose, self-administered generic measure health status. It was developed to measure health-related quality of life, estimate disease burden and compare disease-specific benchmarks across populations. The VR-12 items measure eight health domains: general health perceptions, physical functioning and role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. The instrument produces a physical health and mental health. Assesses how much physical health has changed over a period of time. The VR instruments use a nine-point ordinal response choices for four items in the VR-12. These answers then contribute to the scales for role limitations due to physical and emotional problems and the physical and mental summary scores.
Measured: 18 months.
Brief Pain Inventory (BPI)
The BPI is a widely used, 15-item measure of pain intensity and interference with daily life. The questionnaire assesses three key pain domains: pain intensity, pain interference, and efficacy of pain treatments or medications. The BPI rapidly assesses the functional severity of pain and its impact on function.The BPI rapidly assesses the functional severity of pain and its impact on function. The scale range is 0 to 10. A lower score means pain does not interfere with normal activities of daily living.
Measured: 6 months.
Brief Pain Inventory (BPI)
The BPI is a widely used, 15-item measure of pain intensity and interference with daily life. The questionnaire assesses three key pain domains: pain intensity, pain interference, and efficacy of pain treatments or medications. The BPI rapidly assesses the functional severity of pain and its impact on function. The BPI rapidly assesses the interference of pain and its impact on function. The scale range is 0 to 10. A lower score means pain does not interfere with normal activities of daily living.
Measured: 6 months.
Brief Pain Inventory (BPI)
The BPI is a widely used, 15-item measure of pain intensity and interference with daily life. The questionnaire assesses three key pain domains: pain intensity, pain interference, and efficacy of pain treatments or medications. The BPI rapidly assesses the functional severity of pain and its impact on function. The BPI rapidly assesses the interference of pain and its impact on function. The scale range is 0 to 10. A lower score means pain does not interfere with normal activities of daily living.
Measured: 12 months.
Brief Pain Inventory (BPI)
The BPI is a widely used, 15-item measure of pain intensity and interference with daily life. The questionnaire assesses three key pain domains: pain intensity, pain interference, and efficacy of pain treatments or medications. The BPI rapidly assesses the functional severity of pain and its impact on function. The BPI rapidly assesses the functional severity of pain and its impact on function. The scale range is 0 to 10. A lower score means pain does not interfere with normal activities of daily living.
Measured: 12 months.
Treatment Cost
Compare 2 year treatment cost per patient, associated with fixation of tibial shaft fractures using novel carbon fiber implants in comparison with titanium implants. A Carbon Fiber Implant had a cost of $2,848.35 per device, as the number value below in the Outcome Measure Data Table. We were unable to obtain the cost of the Titanium Nail.
Measured: Baseline to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start23 May 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2021
Why it stopped: Original PI no longer works at UAB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tibial Shaft FracturesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- CarboFix Orthopedics
- Responsible party
- Principal investigator, Clay Spitler, University of Alabama at Birmingham
- Investigators
- Clay A Spitler, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382041
- Sponsor's protocol ID
- F160824002
- Status last verified
- Jul 2023
- First submitted
- 13 Nov 2017
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramedullary Nailing of Tibia Shaft Fractures With Carbon Fiber Implants Versus Titanium Nails: A Randomized Cohort Study
- ClinicalTrials.gov ID
- NCT03382041
- Acronym / sponsor ID
- F160824002
- Conditions
- Tibial Shaft Fractures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Original PI no longer works at UAB
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- CarboFix Orthopedics
- Study start
- 23 May 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Posted 2 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Carbon Fiber Implant | Experimental | Device: Carbon Fiber ImplantThere is an alternative to the standard treatment, which is 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. |
| Titanium Implant | Active comparator | Device: Titanium ImplantThe standard of practice in the treatment of fractures of the tibial shaft and other long bones has been the intramedullary nailing using titanium or stainless steel implants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- 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..
- Patient's informed consent or that of a legally acceptable representative
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon Fiber ImplantA cannulated rod, made of long carbon fiber reinforced polymer, with interlocking holes at its proximal and distal ends. The Nail provides for a slight bend. A Tantalum radiopaque marker along the Nail longitudinal axis provides for its visualization under fluoroscopy. The Nail proximal end is marked by a tantalum marker. | Device | Carbon Fiber Implant |
| Titanium ImplantAn intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail or Küntscher nail (without proximal or distal fixation), is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body | Device | Titanium Implant |
Primary outcome
The Number of Participants Identified With Fracture Healing
Time frame: From baseline through 6 weeks.
Will assess radiographically the fracture healing for patients treated with Carbon Fiber and Titanium Implants.
The Number of Participants Identified With Fracture Healing
Time frame: From baseline through 3 months.
Will assess radiographically the fracture healing for patients treated with Carbon Fiber and Titanium Implants.
20 secondary outcomes
Short Musculoskeletal Function Assessment Questionnaire (SMFA).
Time frame: 6 months
Short Musculoskeletal Function Assessment Questionnaire (SMFA) Score.
Time frame: 6 months
Short Musculoskeletal Function Assessment Questionnaire (SMFA).
Time frame: 12 months.
Short Musculoskeletal Function Assessment Questionnaire (SMFA) Score.
Time frame: 12 months.
Short Musculoskeletal Function Assessment Questionnaire (SMFA) Score.
Time frame: 18 months.
Veterans Rand Health Survey (VR-12)
Time frame: 6 weeks.
Veterans Rand Health Survey (VR-12)
Time frame: 3 months
Veterans Rand Health Survey (VR-12)
Time frame: 6 months
Veterans Rand Health Survey (VR-12)
Time frame: 12 months
Veterans Rand Health Survey (VR-12)
Time frame: 18 months
Veterans Rand Health Survey (VR-12)
Time frame: 6 weeks
Veterans Rand Health Survey (VR-12)
Time frame: 3 months.
Veterans Rand Health Survey (VR-12)
Time frame: 12 months.
Brief Pain Inventory (BPI)
Time frame: 6 months.
Veterans Rand Health Survey (VR-12) (Optional)
Time frame: 18 months.
Brief Pain Inventory (BPI)
Time frame: 6 months.
Brief Pain Inventory (BPI)
Time frame: 6 months.
Brief Pain Inventory (BPI)
Time frame: 12 months.
Brief Pain Inventory (BPI)
Time frame: 12 months.
Treatment Cost
Time frame: Baseline to 18 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Rehabilitation After Lower Extremity Nailing Trial
Femoral Shaft Fracture, Tibial Shaft Fractures
Recruiting
Comparison of Functional Recovery Following Medial Parapatellar and Transpatellar Approaches for Intramedullary Nailing of Tibial Shaft Fractures
Tibial Shaft Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clay A Spitler, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon Fiber Implant and Titanium Implant in people with Tibial Shaft Fractures, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants Identified With Fracture Healing (time frame: From baseline through 6 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.