Trial Outcomes & Findings for Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures (NCT NCT03061279)

NCT ID: NCT03061279

Last Updated: 2020-10-22

Results Overview

Pain on a visual analogue scale (range: 0 to 1; 0 = no pain; 10 = worst pain imaginable).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

Baseline, year 1

Results posted on

2020-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Acutrak Fixation Fixation by Acutrak headless screw: The fixation provided by the Acutrak headless compression screws provide sufficient fixation to achieve union and a favorable clinical outcome in both horizontal and vertical medial malleolus fractures when compared to bicortical and unicortical screw fixation, tension band wiring, and mini-fragment or buttress plating	Standard of Care Fixation Fixation by headed screws, plates, and or wires: DePuy-Synthes Cannulated Cancellous Screws, DePuy-Synthes Cancellous Screws, DePuy-Synthes Cortical Screws, DePuy-Synthes 1/3 Tubular Plate, DePuy-Synthes Locking contrast dynamic compression (LC-DCP) Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire are the alternative methods of treatment of medial malleolus fracture.
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acutrak Fixation Fixation by Acutrak headless screw: The fixation provided by the Acutrak headless compression screws provide sufficient fixation to achieve union and a favorable clinical outcome in both horizontal and vertical medial malleolus fractures when compared to bicortical and unicortical screw fixation, tension band wiring, and mini-fragment or buttress plating	Standard of Care Fixation n=1 Participants Fixation by headed screws, plates, and or wires: DePuy-Synthes Cannulated Cancellous Screws, DePuy-Synthes Cancellous Screws, DePuy-Synthes Cortical Screws, DePuy-Synthes 1/3 Tubular Plate, DePuy-Synthes Locking contrast dynamic compression (LC-DCP) Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire are the alternative methods of treatment of medial malleolus fracture.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, year 1

Population: No analysis was conducted due to small sample size and confidentiality concerns.

Pain on a visual analogue scale (range: 0 to 1; 0 = no pain; 10 = worst pain imaginable).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 3

Population: No analysis was conducted due to small sample size and confidentiality concerns.

Fracture union rate assessed by radiographic imaging.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, year 2

Population: No analysis was conducted due to small sample size and confidentiality concerns.

The PROMIS LEFS scale consists of 20 questions, each on a 5-point Likert scale (0 = extreme difficulty, 4 = no difficulty). Questions are summed for a total score.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, year 2

Population: No analysis was conducted due to small sample size and confidentiality concerns.

The PROMIS depression score is based on an adaptive test, and reported as a cumulative T-score with standard error.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, year 2

Population: No analysis was conducted due to small sample size and confidentiality concerns.

The PROMIS pain interference score is based on an adaptive test, and reported as a cumulative T-score with standard error.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, year 2

Population: No analysis was conducted due to small sample size and confidentiality concerns.

The PROMIS physical function score is based on an adaptive test, and reported as a cumulative T-score with standard error.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: No analysis was conducted due to small sample size and confidentiality concerns.

Pain medication measured in morphine equivalents.

Outcome measures

Outcome data not reported

Adverse Events

Acutrak Fixation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Fixation

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

Derek Amanatullah, MD, PhD

Stanford University

Phone: 650-723-2257

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place