Trial Outcomes & Findings for A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System (NCT NCT04015167)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

103 participants

Primary outcome timeframe

12 months

Results posted on

2025-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	103
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	48

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	40
Overall Study Adverse Event	5
Overall Study Withdrawal by Subject	2
Overall Study Subject went to jail	1

Baseline Characteristics

A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T2 Alpha Tibia n=103 Participants 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.
Age, Continuous	43.81 years STANDARD_DEVIATION 18.53 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian	5 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Black or African	26 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	72 Participants n=5 Participants
Region of Enrollment United States	103 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Of the 55 subjects that completed the study, 53 subjects were available for the SF-36 assessment

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.

Outcome measures

Outcome measures
Measure	T2 Alpha Tibia n=53 Participants 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.
SF-36 PCS (36-Item Short Form Health Survey Physical Component Summary)	49.21 score on a scale Standard Deviation 9.65

SECONDARY outcome

Timeframe: 12 months

Population: 11 out of 103 subjects had reportable Adverse Events.

Incidence of device-related adverse events will be monitored by 12 months through data collection and analyses.

Outcome measures

Outcome measures
Measure	T2 Alpha Tibia n=11 Participants 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.
Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events *Delayed union (no bone consolidation within 4 months)	2 Participants
Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events Implant loosening (screw)	1 Participants
Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events Infection (deep)	2 Participants
Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events Non-union (no bone consolidation within 6 months)	2 Participants
Safety Will be Measured by Capturing the Incidence Rate of Device-related Adverse Events Pain	4 Participants

SECONDARY outcome

Timeframe: 12 months

Population: of the 55 subjects that completed the study, 54 subjects were available for bone consolidation assessment.

Bone consolidation will be assessed by 12 months as measured by Investigator assessment.

Outcome measures

Outcome measures
Measure	T2 Alpha Tibia n=54 Participants 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.
Efficacy/Performance Will be Measured by Demonstration of Bone Consolidation Bone Consolidation - Yes	48 Participants
Efficacy/Performance Will be Measured by Demonstration of Bone Consolidation Bone Consolidation - No	6 Participants

Adverse Events

T2 Alpha Tibia

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	T2 Alpha Tibia n=103 participants at risk 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.
Musculoskeletal and connective tissue disorders Delayed union (no bone consolidation within 4 months)	1.9% 2/103 • 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Product Issues Implant loosening (screw)	0.97% 1/103 • 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Infections and infestations Infection (deep)	1.9% 2/103 • 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Non-union (no bone consolidation within 6 months)	1.9% 2/103 • 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Product Issues Pain	3.9% 4/103 • 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.

Additional Information

Monica Fleeman

Stryker

Phone: 251-465-5969

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place