Tibial Fractures
Conditions
Brief summary
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 80 subjects will be enrolled. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the T2 Alpha Tibia Nailing System. Total duration of enrollment, 12 month follow-up and analysis is expected to take 31 months. The clinical investigation has been designed to follow the surgeon's standard of care for tibia fractured subjects, in addition to a 12 month follow-up visit. The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the SF-36 Physical Component Summary (PCS). Confirmation of efficacy/performance at 12 months will be based on an equal or higher (non-inferior) SF-36 Physical Component Summary (PCS) result of the T2 Alpha Tibia Nailing System compared to the benchmark literature.
Detailed description
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the T2 Alpha Tibia Nailing System. Efficacy/performance of the procedure will be measured by an equal or higher (non-inferior) SF-36 Physical Component Summary (PCS) score result of the T2 Alpha Tibia Nailing System compared to the T2 Tibia benchmark literature at 12 months. In addition, demonstration of bone consolidation in correct alignment will be measured by Investigator assessment by 12 months. Safety of the T2 Alpha Tibia Nailing System will be demonstrated through reporting of device related intra-operative and post-operative Adverse Events/incidents by 12 months.
Interventions
DEVICET2 Alpha Tibia Nailing System
The T2 Alpha Tibia Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Subject is a male or non-pregnant female age 18 years or older at the time of surgery; * Subject is willing and able to give written informed consent and comply with the requirements of this Clinical Investigation Plan; * Subject is intended to be, treated with the Tibial Nail of the T2 Alpha Tibia Nailing System in accordance with the following legally cleared/ approved Indications for Use: Indications for Use approved In United States and Canada include: * Open and closed tibial fractures * Pseudoarthrosis and correction osteotomy * Pathologic fractures, impending pathologic fractures and tumor resections * Fractures involving osteopenic and osteoporotic bone * Nonunions and malunions
Exclusion criteria
* Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device clinical investigation that, in the opinion of the Investigator, may confound results; * Per the Investigator, the subject is in poor general health or undergoing any concurrent disease that would place the subject in excessive risk to surgery (i.e. significant circulatory problems, cardiac disease).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 PCS (36-Item Short Form Health Survey Physical Component Summary) | 12 months | The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the SF-36 PCS (36-Item Short Form Health Survey Physical Component Summary). The SF-36 PCS is a self-report measure of health status. SF-36 Physical Component Summary scores range from 0 to 100; higher SF-36 score results are linked to better subject results. Confirmation of efficacy/performance at 12 months will be based on an equal or higher (non-inferior) SF-36 Physical Component Summary (PCS) result of the T2 Alpha Tibia Nailing System compared to the T2 Tibia benchmark literature. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events | 12 months | Incidence of device-related adverse events will be monitored by 12 months through data collection and analyses. |
| Efficacy/Performance Will be Measured by Demonstration of Bone Consolidation | 12 months | Bone consolidation will be assessed by 12 months as measured by Investigator assessment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T2 Alpha Tibia Subjects in the clinical investigation will undergo placement of the Tibial Nail of the T2 Alpha Tibia Nailing System, according to the approved Instructions for Use and Operative Technique Manual.
T2 Alpha Tibia Nailing System: The T2 Alpha Tibia Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved. | 103 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Lost to Follow-up | 40 |
| Overall Study | Subject went to jail | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | T2 Alpha Tibia |
|---|---|
| Age, Continuous | 43.81 years STANDARD_DEVIATION 18.53 |
| Race/Ethnicity, Customized Ethnicity Asian | 5 Participants |
| Race/Ethnicity, Customized Ethnicity Black or African | 26 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 72 Participants |
| Region of Enrollment United States | 103 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 103 |
| other Total, other adverse events | 11 / 103 |
| serious Total, serious adverse events | 0 / 103 |
Outcome results
Primary
SF-36 PCS (36-Item Short Form Health Survey Physical Component Summary)
The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the SF-36 PCS (36-Item Short Form Health Survey Physical Component Summary). The SF-36 PCS is a self-report measure of health status. SF-36 Physical Component Summary scores range from 0 to 100; higher SF-36 score results are linked to better subject results. Confirmation of efficacy/performance at 12 months will be based on an equal or higher (non-inferior) SF-36 Physical Component Summary (PCS) result of the T2 Alpha Tibia Nailing System compared to the T2 Tibia benchmark literature.
Time frame: 12 months
Population: Of the 55 subjects that completed the study, 53 subjects were available for the SF-36 assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T2 Alpha Tibia | SF-36 PCS (36-Item Short Form Health Survey Physical Component Summary) | 49.21 score on a scale | Standard Deviation 9.65 |
Secondary
Efficacy/Performance Will be Measured by Demonstration of Bone Consolidation
Bone consolidation will be assessed by 12 months as measured by Investigator assessment.
Time frame: 12 months
Population: of the 55 subjects that completed the study, 54 subjects were available for bone consolidation assessment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| T2 Alpha Tibia | Efficacy/Performance Will be Measured by Demonstration of Bone Consolidation | Bone Consolidation - Yes | 48 Participants |
| T2 Alpha Tibia | Efficacy/Performance Will be Measured by Demonstration of Bone Consolidation | Bone Consolidation - No | 6 Participants |
Secondary
Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events
Incidence of device-related adverse events will be monitored by 12 months through data collection and analyses.
Time frame: 12 months
Population: 11 out of 103 subjects had reportable Adverse Events.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| T2 Alpha Tibia | Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events | *Delayed union (no bone consolidation within 4 months) | 2 Participants |
| T2 Alpha Tibia | Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events | Implant loosening (screw) | 1 Participants |
| T2 Alpha Tibia | Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events | Infection (deep) | 2 Participants |
| T2 Alpha Tibia | Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events | Non-union (no bone consolidation within 6 months) | 2 Participants |
| T2 Alpha Tibia | Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events | Pain | 4 Participants |