Trial Outcomes & Findings for An Investigation on Function and Performance of a New Microprocessor Controlled Prosthetic Knee (NCT NCT05523349)

Results Overview

A question from the Prosthesis Evaluation Questionnaire (PEQ) regarding the satisfaction of walking downstairs is answered; scale allows for values from 1 to 10 while 1 represents very low satisfaction and 10 high satisfaction. The analysis was done by using a Bayesian approach which presents the posterior distribution of effects between Visit 2 and visit 3. The parameter for analysis is the difference of the score between Visits 2 and 3. If scores in Visit 2 (subjects using the investigational device) were larger than in visit 3 (subjects using their prescribed device), the difference of Visit3 - Visit2 scores would be negative and would therefore support the corresponding hypotheses. The Median difference and range of the Confidence interval of the difference are reported in the outcome measure data table.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

for analysis data from visit 2 (3 weeks after visit 1) and visit 3 (3 weeks after visit 2) were used

Results posted on

2026-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Users will be fitted with a new microprocessor-controlled prosthetic knee for 3 weeks to compare to their usual device. NAVii: Passive Microprocessor-controlled prosthetic knee
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=14 Participants Users will be fitted with a new microprocessor-controlled prosthetic knee for 3 weeks to compare to their usual device. NAVii: Passive Microprocessor-controlled prosthetic knee
Age, Continuous	46.4 years STANDARD_DEVIATION 16.8 • n=14 Participants
Sex: Female, Male Female	3 Participants n=14 Participants
Sex: Female, Male Male	11 Participants n=14 Participants
Region of Enrollment United States	12 Participants n=14 Participants
Region of Enrollment Iceland	2 Participants n=14 Participants
PLUS-M T-Score	55.3 T-score STANDARD_DEVIATION 4.9 • n=14 Participants
Socket Comfort Score	9.1 scores on a scale STANDARD_DEVIATION 0.9 • n=14 Participants

PRIMARY outcome

Timeframe: for analysis data from visit 2 (3 weeks after visit 1) and visit 3 (3 weeks after visit 2) were used

A question from the Prosthesis Evaluation Questionnaire (PEQ) regarding the satisfaction of walking downstairs is answered; scale allows for values from 1 to 10 while 1 represents very low satisfaction and 10 high satisfaction. The analysis was done by using a Bayesian approach which presents the posterior distribution of effects between Visit 2 and visit 3. The parameter for analysis is the difference of the score between Visits 2 and 3. If scores in Visit 2 (subjects using the investigational device) were larger than in visit 3 (subjects using their prescribed device), the difference of Visit3 - Visit2 scores would be negative and would therefore support the corresponding hypotheses. The Median difference and range of the Confidence interval of the difference are reported in the outcome measure data table.

Outcome measures

Outcome measures
Measure	All Participants n=14 Participants Users will be fitted with a new microprocessor-controlled prosthetic knee for 3 weeks to compare to their usual device. NAVii: Passive Microprocessor-controlled prosthetic knee
Satisfaction During Stair Descent	0.80 score on a scale Interval -0.5 to 2.1

SECONDARY outcome

Timeframe: for the final analysis data from visit 2 (3 weeks after visit 1) and visit 3 (3 weeks after visit 2) were used

Population: One subject had only limited lung function. At the first visit, the subject wanted to give it a try to walk the full 6 minutes, but the measurement was aborted by the investigators as the test was considered too demanding. The 6 MWT was skipped for that subject in the consecutive visits. One subject did not complete the 6 MWT at the last visit with Rheo knee as the subject reported on functional issues of the knee. Their CPO has taken care of the issue.

The Six Minute Walk test (6MWT) is 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.

Outcome measures

Outcome measures
Measure	All Participants n=12 Participants Users will be fitted with a new microprocessor-controlled prosthetic knee for 3 weeks to compare to their usual device. NAVii: Passive Microprocessor-controlled prosthetic knee
Six Minute Walk Test Visit 2	326.8 meter Standard Deviation 90.7
Six Minute Walk Test Visit 3	326.7 meter Standard Deviation 82.6

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=14 participants at risk Users will be fitted with a new microprocessor-controlled prosthetic knee for 3 weeks to compare to their usual device. NAVii: Passive Microprocessor-controlled prosthetic knee
Social circumstances Fall	7.1% 1/14 • Number of events 1 • adverse event data were collected over the time of participation starting with the first visit until the third visit (6 weeks for each participant)

Additional Information

Lisa Tronicke

Össur ehf.

Phone: +4915155367970

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place