An Investigation on Function and Performance of a New Microprocessor Controlled Prosthetic Knee

NCT05523349 | Completed Results FDA Device

• 1 other identifier: CIP2022022514
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 4

Brief Summary

This investigation aims to compare the functional performance of a new passive microprocessor-controlled Prosthetic Knee to subjects usual microprocessor-controlled prosthetic knee.

Conditions

Prosthesis User; Amputation

Outcome Measures

Primary Outcomes (1)

• Satisfaction During Stair Descent

  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.

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

Secondary Outcomes (1)

• Six Minute Walk Test

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

Study Arms (1)

NAVii

EXPERIMENTAL

Users will be fitted with a new microprocessor-controlled prosthetic knee for 3 weeks to compare to their usual device.

Device: NAVii

Interventions

NAVii DEVICE

Passive Microprocessor-controlled prosthetic knee

NAVii

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kg\< body weight \< 136Kg
• Cognitive ability to understand all instructions and questionnaires in the study;
• Unilateral TF/KD amputees that are regular prosthesis users for at least 3 months
• Current MPK users (passive MPKs only)
• Age ≥ 18 years
• Willing and able to participate in the study and follow the protocol
• Moderate to high active users (PLUS M T-score\>4021)

You may not qualify if:

• Users with stump pain
• Users with socket problems
• Pregnant Users
• Users using Power Knee, Kenevo or mechanical knees as their prescribed prosthesis
• Alignment that cannot be matched with the Rheo Knee 4 setup, as described in Instructions for use.
• Osseointegration

Sponsors & Collaborators

• Össur Iceland ehf: lead

Study Sites (4)

Bionic P & O

Merrillville, Indiana, 46410, United States

Location

Oakland Orthopedic appliances

Bay City, Michigan, 48708, United States

Location

Perry Prosthetics

Perrysburg, Ohio, 43551, United States

Location

Ossur Motionlab

Reykjavik, 110, Iceland

Location

Limitations and Caveats

Prosthetic use time was not monitored or controlled for during the adaptation time period, the actual time each subject used the investigational device is therefore unknown. The sample of the trial represents only a small portion of the whole population with above knee amputation.

Results Point of Contact

• Title: Lisa Tronicke
• Organization: Össur ehf.

ltronicke@ossur.com

+4915155367970

Study Officials

• Kurt N Gruben, CPO

  Ossur Americas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Considering previous experience with clinical investigations in prosthetics it was concluded to conduct a non-randomized prospective repeated measures (ABA) design, comparing subjects' current MPK at baseline and 3-week follow-up vs. the investigational device at 3-week follow-up.

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: August 15, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: February 2, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1); US (3)