Trial Outcomes & Findings for Carbon Fiber Implants (NCT NCT03382041)

NCT ID: NCT03382041

Last Updated: 2023-07-25

Results Overview

Will assess radiographically the fracture healing for patients treated with Carbon Fiber and Titanium Implants.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: From baseline through 6 weeks.
• Results posted on: 2023-07-25

Participant Flow

Participant milestones

Measure	Carbon Fiber Implant 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. Carbon Fiber Implant: 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 Implant 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. Titanium Implant: 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
Overall Study STARTED	7	13
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	4	9

Reasons for withdrawal

Measure	Carbon Fiber Implant 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. Carbon Fiber Implant: 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 Implant 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. Titanium Implant: 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
Overall Study Consent Form Lost	2	1
Overall Study Withdrawal by Subject	1	4
Overall Study Lost to Follow-up	1	4

Baseline Characteristics

Carbon Fiber Implants

Baseline characteristics by cohort

Measure	Carbon Fiber Implant n=7 Participants 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. Carbon Fiber Implant: 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 Implant n=13 Participants 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. Titanium Implant: 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	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	13 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline through 6 weeks.

Population: 7 subjects were withdrawn due to the discretion of the PI, 2 subjects withdrew consent, 6 subjects were lost to follow-up.

Will assess radiographically the fracture healing for patients treated with Carbon Fiber and Titanium Implants.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
The Number of Participants Identified With Fracture Healing	1 Participants	1 Participants

PRIMARY outcome

Timeframe: From baseline through 3 months.

Population: 7 subjects were withdrawn due to the discretion of the PI, 2 subjects withdrew consent, 6 subjects were lost to follow-up, 1 subject did not have x-rays done.

Will assess radiographically the fracture healing for patients treated with Carbon Fiber and Titanium Implants.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=3 Participants 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. Titanium Implant: 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
The Number of Participants Identified With Fracture Healing	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Short Musculoskeletal Function Assessment Questionnaire (SMFA).	31.53 units on a scale Standard Deviation 20.55	38.56 units on a scale Standard Deviation 32.46

SECONDARY outcome

Timeframe: 6 months

Population: One patient wasn't available to evaluate from the Titanium group.

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=3 Participants 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. Titanium Implant: 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
Short Musculoskeletal Function Assessment Questionnaire (SMFA) Score.	32.39 units on a scale Standard Deviation 22.60	49.24 units on a scale Standard Deviation 46.71

SECONDARY outcome

Timeframe: 12 months.

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Short Musculoskeletal Function Assessment Questionnaire (SMFA).	29.85 units on a scale Standard Deviation 28.35	31.09 units on a scale Standard Deviation 27.85

SECONDARY outcome

Timeframe: 12 months.

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Short Musculoskeletal Function Assessment Questionnaire (SMFA) Score.	34.09 units on a scale Standard Deviation 32.06	37.88 units on a scale Standard Deviation 36.46

SECONDARY outcome

Timeframe: 18 months.

Population: Data was not collected.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks.

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Veterans Rand Health Survey (VR-12)	31.63 units on a scale Standard Deviation 3.72	25.53 units on a scale Standard Deviation 8.42

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Veterans Rand Health Survey (VR-12)	48.03 T-score Standard Deviation 15.46	44.90 T-score Standard Deviation 1.95

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Veterans Rand Health Survey (VR-12)	36.03 units on a scale Standard Deviation 15.24	38.20 units on a scale Standard Deviation 20.92

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Veterans Rand Health Survey (VR-12)	41.63 units on a scale Standard Deviation 16.87	47.83 units on a scale Standard Deviation 19.12

SECONDARY outcome

Timeframe: 18 months

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Veterans Rand Health Survey (VR-12)	39.93 units on a scale Standard Deviation 10.75	40.63 units on a scale Standard Deviation 24.31

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Veterans Rand Health Survey (VR-12)	41.08 units on a scale Standard Deviation 6.61	43.07 units on a scale Standard Deviation 5.12

SECONDARY outcome

Timeframe: 3 months.

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Veterans Rand Health Survey (VR-12)	40.20 units on a scale Standard Deviation 18.67	36.10 units on a scale Standard Deviation 42.47

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Veterans Rand Health Survey (VR-12)	39.57 units on a scale Standard Deviation 8.75	38.40 units on a scale Standard Deviation 10.15

SECONDARY outcome

Timeframe: 12 months.

Population: The participants were not analyzed at the 18 month time point.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months.

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Brief Pain Inventory (BPI)	1.38 units on a scale Standard Deviation 1.49	2.75 units on a scale Standard Deviation 3.54

SECONDARY outcome

Timeframe: 18 months.

Population: The Carbon Fiber implants (3 participants) and the Titanium implants (4 participants) were healed and did not participate in this evaluation.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months.

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Brief Pain Inventory (BPI)	1.38 units on a scale Standard Deviation 1.49	2.75 units on a scale Standard Deviation 3.54

SECONDARY outcome

Timeframe: 6 months.

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Brief Pain Inventory (BPI)	2.21 units on a scale Standard Deviation 0.69	3.10 units on a scale Standard Deviation 5.36

SECONDARY outcome

Timeframe: 12 months.

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Brief Pain Inventory (BPI)	3.10 units on a scale Standard Deviation 2.40	2.33 units on a scale Standard Deviation 4.04

SECONDARY outcome

Timeframe: 12 months.

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.

Outcome measures

Measure	Carbon Fiber Implant n=3 Participants 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. Carbon Fiber Implant: 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 Implant n=4 Participants 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. Titanium Implant: 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
Brief Pain Inventory (BPI)	1.17 units on a scale Standard Deviation 1.26	0.58 units on a scale Standard Deviation 0.80

SECONDARY outcome

Timeframe: Baseline to 18 months.

Population: Costs were determined for 1 carbon fiber implant. Costs were not available for 2 carbon fiber implant participants and 4 Titanium implant participants.

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.

Outcome measures

Measure	Carbon Fiber Implant n=1 Participants 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. Carbon Fiber Implant: 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 Implant 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. Titanium Implant: 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
Treatment Cost	2,848.35 Dollars	—

Adverse Events

Carbon Fiber Implant

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Titanium Implant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Carbon Fiber Implant n=3 participants at risk 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. Carbon Fiber Implant: 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 Implant n=4 participants at risk 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. Titanium Implant: 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
Surgical and medical procedures Right tibia malunion	33.3% 1/3 • Number of events 1 • Baseline through 12 months	0.00% 0/4 • Baseline through 12 months
Surgical and medical procedures Fracture-left proximal tibial plateau	33.3% 1/3 • Number of events 1 • Baseline through 12 months	0.00% 0/4 • Baseline through 12 months
Infections and infestations Sepsis secondary to hardware infection	33.3% 1/3 • Number of events 1 • Baseline through 12 months	0.00% 0/4 • Baseline through 12 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Clay Spitler

The University of Alabama at Birmingham (UAB)

Phone: 205-934-6413

Email: caspitler@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place