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Carbon Fiber Implants
NA trial testing Carbon Fiber Implant in Tibial Shaft Fractures in 20 participants. Terminated before completion.
| Lead sponsor | University of Alabama at Birmingham |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 23 May 2017 |
| Primary completion | 31 March 2020 |
| Estimated completion | 31 March 2021 |
| Sites | 1 location across United States |
University of Alabama at Birmingham
18 and older, any sex, with Tibial Shaft Fractures. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Will assess radiographically the fracture healing for patients treated with Carbon Fiber and Titanium Implants.
| Group | Value | 95% CI |
|---|---|---|
| Carbon Fiber Implant | 1 | |
| Titanium Implant | 1 |
Will assess radiographically the fracture healing for patients treated with Carbon Fiber and Titanium Implants.
| Group | Value | 95% CI |
|---|---|---|
| Carbon Fiber Implant | 1 | |
| Titanium Implant | 2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Carbon Fiber Implant | 31.53 | ± 20.55 |
| Titanium Implant | 38.56 | ± 32.46 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Carbon Fiber Implant | 32.39 | ± 22.60 |
| Titanium Implant | 49.24 | ± 46.71 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Carbon Fiber Implant | 29.85 | ± 28.35 |
| Titanium Implant | 31.09 | ± 27.85 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Carbon Fiber Implant | 34.09 | ± 32.06 |
| Titanium Implant | 37.88 | ± 36.46 |
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 t
| Group | Value | 95% CI |
|---|---|---|
| Carbon Fiber Implant | 31.63 | ± 3.72 |
| Titanium Implant | 25.53 | ± 8.42 |
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
| Group | Value | 95% CI |
|---|---|---|
| Carbon Fiber Implant | 48.03 | ± 15.46 |
| Titanium Implant | 44.90 | ± 1.95 |
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 cho
| Group | Value | 95% CI |
|---|---|---|
| Carbon Fiber Implant | 36.03 | ± 15.24 |
| Titanium Implant | 38.20 | ± 20.92 |
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 cho
| Group | Value | 95% CI |
|---|---|---|
| Carbon Fiber Implant | 41.63 | ± 16.87 |
| Titanium Implant | 47.83 | ± 19.12 |
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 cho
| Group | Value | 95% CI |
|---|---|---|
| Carbon Fiber Implant | 39.93 | ± 10.75 |
| Titanium Implant | 40.63 | ± 24.31 |
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 cho
| Group | Value | 95% CI |
|---|---|---|
| Carbon Fiber Implant | 41.08 | ± 6.61 |
| Titanium Implant | 43.07 | ± 5.12 |
Time frame: Baseline through 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Carbon Fiber Implant | Titanium Implant |
|---|---|---|---|
| Right tibia malunion | Surgical and medical procedures | — | — |
| Fracture-left proximal tibial plateau | Surgical and medical procedures | — | — |
| Sepsis secondary to hardware infection | Infections and infestations | — | — |
Most-reported serious reactions: Right tibia malunion, Fracture-left proximal tibial plateau, Sepsis secondary to hardware infection.
Data from ClinicalTrials.gov NCT03382041 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial.
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