Trial Outcomes & Findings for Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures (NCT NCT00610701)

Results Overview

measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

(admission, 6 weeks, 3 months, 6 months) 1 year

Results posted on

2017-07-24

Participant milestones
Measure	1 Anterior Anterior Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins	2 Lateral Lateral Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind
Overall Study STARTED	15	20
Overall Study COMPLETED	5	9
Overall Study NOT COMPLETED	10	11

Withdrawal data not reported

Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

Baseline characteristics by cohort
Measure	1-anterior Pin Placement n=5 Participants Anterior Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins	2-lateral Pin Placement n=9 Participants Lateral Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	9 participants n=7 Participants	14 participants n=5 Participants

Timeframe: (admission, 6 weeks, 3 months, 6 months) 1 year

measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose

Outcome measures
Measure	1-anterior Pin Placement n=5 Participants Anterior Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins	2-lateral Pin Placement n=9 Participants Lateral Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind
Quadriceps Strength	35.9 Nm Standard Deviation 10.7	39.6 Nm Standard Deviation 17.7

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	1 Anterior n=5 participants at risk Anterior Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins	2 Lateral n=9 participants at risk Lateral Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind
Injury, poisoning and procedural complications death	20.0% 1/5 • Number of events 1 • 1 year 14 patients completed the study	22.2% 2/9 • Number of events 2 • 1 year 14 patients completed the study
Infections and infestations infection	0.00% 0/5 • 1 year 14 patients completed the study	11.1% 1/9 • Number of events 1 • 1 year 14 patients completed the study
Musculoskeletal and connective tissue disorders arthrofibrosis	20.0% 1/5 • Number of events 1 • 1 year 14 patients completed the study	0.00% 0/9 • 1 year 14 patients completed the study

Adverse event data not reported

University of Missouri

Phone: 5738826562