Trial Outcomes & Findings for Compass Hinge Stabilization of Knee Dislocations: A Randomized Trial (NCT NCT00582517)

Results Overview

The hypothesis of this study was that there would be equivalent final knee range of motion with fewer failures for ligament reconstructions following knee dislocations that were supplemented with the Compass Knee Hinge as compared to a control group.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

12 months

Results posted on

2017-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Group A External Brace Group A will have a non-invasive range of motion external brace placed following surgery	Group B Compass Knee Hinge Group B will have a Compass Knee Hinge placed
Overall Study STARTED	45	55
Overall Study COMPLETED	45	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Compass Hinge Stabilization of Knee Dislocations: A Randomized Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A External Brace n=45 Participants Group A will have a non-invasive range of motion external brace placed following surgery	Group B Compass Knee Hinge n=55 Participants Group B will have a Compass Knee Hinge placed	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=93 Participants	52 Participants n=4 Participants	97 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	16 Participants n=4 Participants	24 Participants n=27 Participants
Sex: Female, Male Male	37 Participants n=93 Participants	39 Participants n=4 Participants	76 Participants n=27 Participants
Region of Enrollment United States	45 participants n=93 Participants	55 participants n=4 Participants	100 participants n=27 Participants

PRIMARY outcome

Timeframe: 12 months

The hypothesis of this study was that there would be equivalent final knee range of motion with fewer failures for ligament reconstructions following knee dislocations that were supplemented with the Compass Knee Hinge as compared to a control group.

Outcome measures

Outcome measures
Measure	Group A External Brace n=45 Participants Group A will have a non-invasive range of motion external brace placed following surgery. Stability of the knee determined by Continuous Passive Motion (CPM) machines and range of motion reached.	Group B Compass Knee Hinge n=55 Participants Group B will have a Compass Knee Hinge placed. Stability of the knee determined by Continuous Passive Motion (CPM) machines and range of motion reached.
Knee Stability Stable at 30 degree plane	29 participants	26 participants
Knee Stability Unstable at 30 degree plane	12 participants	17 participants
Knee Stability Stable at 70 degree plane	27 participants	30 participants
Knee Stability Unstable at 70 degree plane	14 participants	13 participants
Knee Stability Stable at 90 degree plane	4 participants	12 participants

Adverse Events

Group A External Brace

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B Compass Knee Hinge

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

Taylor Vlack, RN

University of Alabama at Birmingham

Phone: 205-996-6781

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place