Trial Outcomes & Findings for An Investigation of Functional Improvements in the RHEO KNEE Compared to Hydraulic Microprocessor Controlled Knees (MPKs) (NCT NCT04023578)

Results Overview

The 6MWT is simply a record of the distance traveled by a given patient at his or her self-selected walking speed over a period of six minutes. All that is required is a stopwatch and a walking corridor or track of known distance. Those administering the test should avoid walking with or in front of test subjects to avoid pacing individuals outside of their self-selected walking speed. The outcome of the test is the distance walked in 6 minutes, in meters.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Measured at baseline and after 3 weeks follow up.

Results posted on

2020-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	Rheo Knee XC Amputee subjects currently using either magneto-rehologic or hydraulic MPKs are fitted with the Rheo Knee XC, a magneto-rheologic MPK. RHEO KNEE XC: Microprocessor controlled knee using Magneto-Rheologic techonology.
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Investigation of Functional Improvements in the RHEO KNEE Compared to Hydraulic Microprocessor Controlled Knees (MPKs)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rheo Knee XC n=13 Participants Amputee subjects currently using either magneto-rehologic or hydraulic MPKs are fitted with the Rheo Knee XC, a magneto-rheologic MPK. RHEO KNEE XC: Microprocessor controlled knee using Magneto-Rheologic techonology.
Age, Continuous	42.4 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Weight	82 Kg STANDARD_DEVIATION 17.3 • n=5 Participants

PRIMARY outcome

Timeframe: Measured at baseline and after 3 weeks follow up.

Population: The outcome reported was collected at 3 week follow up on the investigational device.

The 6MWT is simply a record of the distance traveled by a given patient at his or her self-selected walking speed over a period of six minutes. All that is required is a stopwatch and a walking corridor or track of known distance. Those administering the test should avoid walking with or in front of test subjects to avoid pacing individuals outside of their self-selected walking speed. The outcome of the test is the distance walked in 6 minutes, in meters.

Outcome measures

Outcome measures
Measure	Rheo Knee XC n=13 Participants Amputee subjects currently using either magneto-rehologic or hydraulic MPKs are fitted with the Rheo Knee XC, a magneto-rheologic MPK. RHEO KNEE XC: Microprocessor controlled knee using Magneto-Rheologic techonology.	Baseline n=13 Participants Measurements on subjects usual prosthesis
6 Minute Walk Test (6MWT)	506 Meters Interval 376.0 to 667.0	428.23 Meters Interval 340.0 to 590.0

Adverse Events

Rheo Knee XC

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

Kristleifur Kristleifsson

Ossur Iceland ehf

Phone: 6641112

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place