An observational study in Tibial Fractures, sponsored by Stryker Trauma and Extremities. Completed at 4 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Stryker Trauma and Extremities · Observational
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 103 is close to the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Stryker Trauma and Extremities is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Approximately 80 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for treatment of tibial fractures will be evaluated for clinical investigation participation based on the eligibility criteria.
Indications for Use approved In United States and Canada include:
Exclusion Criteria:
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.
Device: 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.
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
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
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
| Milestone | T2 Alpha Tibia |
|---|---|
| Started | 103 |
| Completed | 55 |
| Not completed | 48 |
| Withdrew: Lost to follow-up | 40 |
| Withdrew: Adverse event | 5 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Subject went to jail | 1 |
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.
| score on a scale | T2 Alpha Tibia |
|---|---|
| SF-36 PCS (36-Item Short Form Health Survey Physical Component Summary) | 49.21 ± 9.65 |
Incidence of device-related adverse events will be monitored by 12 months through data collection and analyses.
| Participants | T2 Alpha Tibia |
|---|---|
| *Delayed union (no bone consolidation within 4 months) | 2 |
| Implant loosening (screw) | 1 |
| Infection (deep) | 2 |
| Non-union (no bone consolidation within 6 months) | 2 |
| Pain | 4 |
Bone consolidation will be assessed by 12 months as measured by Investigator assessment.
| Participants | T2 Alpha Tibia |
|---|---|
| Bone Consolidation - Yes | 48 |
| Bone Consolidation - No | 6 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| T2 Alpha Tibia | 0/103 (0%) | 0/103 (0%) | 11/103 (10.7%) |
| Event | T2 Alpha Tibia |
|---|---|
| PainProduct Issues | 4/103 |
| Delayed union (no bone consolidation within 4 months)Musculoskeletal and connective tissue disorders | 2/103 |
| Infection (deep)Infections and infestations | 2/103 |
| Non-union (no bone consolidation within 6 months)Musculoskeletal and connective tissue disorders | 2/103 |
| Implant loosening (screw)Product Issues | 1/103 |
| Age, Continuous(years) | T2 Alpha Tibia |
|---|---|
| Mean | 43.81 ± 18.53 |
| Sex: Female, Male(Participants) | T2 Alpha Tibia |
|---|---|
| Female | 41 |
| Male | 62 |
| Race/Ethnicity, Customized(Participants) | T2 Alpha Tibia |
|---|---|
| Ethnicity — Asian | 5 |
| Ethnicity — Black or African | 26 |
| Ethnicity — Caucasian | 72 |
| Region of Enrollment(participants) | T2 Alpha Tibia |
|---|---|
| United States | 103 |
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Stryker Trauma and Extremities