Trial Outcomes & Findings for Computed Tomography for Evaluating Supination-external Rotation Type Ankle Fractures (NCT NCT02599441)

NCT ID: NCT02599441

Last Updated: 2019-10-25

Results Overview

measured on weight bearing CBCT

• Recruitment status: COMPLETED
• Target enrollment: 9 participants
• Primary outcome timeframe: Baseline- single-day study
• Results posted on: 2019-10-25

Participant Flow

Participant milestones

Measure	Ankle Fracture Cases 9 patients with SER ankle fractures
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Computed Tomography for Evaluating Supination-external Rotation Type Ankle Fractures

Baseline characteristics by cohort

Measure	Ankle Fracture Cases n=9 Participants 9 ankle fractures included in the study
Age, Continuous	50.3 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline- single-day study

measured on weight bearing CBCT

Outcome measures

Measure	Ankle Fracture Cases n=9 Participants 9 ankle fractures included in the study
Medial Clear Space Distance in the Ankle Joint	1.41 mm Standard Deviation 0.41

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Ankle Fracture Cases n=9 Participants 9 ankle fractures included in the study
Medial Clear Space on Gravity Stress Xray	5.82 mm Standard Deviation 1.93

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Ankle Fracture Cases n=9 Participants 9 ankle fractures included in the study
Medial Clear Space on Standard Xray	3.28 mm Standard Deviation 1.63

Adverse Events

Ankle Fracture Cases

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research coordinator

University at Buffalo

Phone: 7162043209

Email: mk67@buffalo.edu

Results disclosure agreements

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