Clinical Investigation (Beta) of a New Developed Prosthetic Knee

Primary outcomes

1. Satisfaction on Ramp Descent With the New Microprocessor-controlled Prosthetic Knee (MPK)

   Time frame: After 4 weeks of use

   Satisfaction on ramp descent with the new MPK compared to prescribed device In-house questionnaire and Scale used: worse, same, better.

2. Satisfaction on Stair Descent With the New Microprocessor-controlled Prosthetic Knee (MPK)

   Time frame: After 4 weeks of use

   Satisfaction on stair descent with the new MPK compared to prescribed device In-house questionnaire and Scale used: worse, same, better

3. Satisfaction on Level Ground Walking Activity

   Time frame: After 4 weeks of use

   Satisfaction on level ground walking activity with the new MPK compared to prescribed device In-house questionnaire and Scale used: worse, same, better

4. Change in Overall Satisfaction From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use

   Time frame: Baseline and After 4 weeks of use

   The PEQ (Prosthesis Evaluation Questionnaire) assesses the quality of life and satisfaction for prosthetic users using a visual analog scale from 0 to 100, where higher scores indicate more positive responses. Only certain subsets were used, including the ambulation subscale, satisfaction and safety questions, and utility questions. The hypothesis tested was that the new MPK has a 95% chance of not negatively affecting overall satisfaction. If scores in Visit 2 (with the investigational device) were higher than in Visit 1 (with the prescribed device), it would support the hypothesis. The confidence interval bars represented in graph were visually compared to the margin of non-inferiority. No further statistical analysis was done.

5. Change in Distance Walked During 2-Minute Walk Test (2MWT) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use

   Time frame: Baseline and After 4 weeks of use

   Average difference in distance walked in 2MWT with the new MPK compared to comparator (prescribed device) User walk for 2 minutes in their self selected walking speed on a 30 meter track.

   The hypothesis being tested is that the new MPK has a 95% probability of not negatively affecting the distance walked on 2MWT.

   For this hypothesis, if scores in visit 2 (subjects using the investigational device) were higher than in visit 1 (subjects using their prescribed device), the difference of Visit 2 - Visit 1 would be positive and would therefore support the corresponding hypothesis.

   The confidence interval bars represented in graph were visually compared to the margin of non-inferiority. No further statistical analysis was done.

6. Change in Time for the Timed Up and Go Test (TUG) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use

   Time frame: Baseline and After 4 weeks of use

   The TUG test is a simple evaluative test used to measure functional mobility and assess fall risk. Reduction in time (measured in seconds) to complete indicates improvement in mobility. Average time needed to perform the TUG with the new MPK compared to comparator (prescribed device). The hypothesis being tested is that the new MPK has a 95% probability of not negatively affecting the time needed to complete the TUG. For this hypothesis, if the completion times of the TUG during the Visit 2 (subjects using the investigational device) were lower than the ones in Visit 1 (subjects using their prescribed device), the difference of Visit 2 - Visit 1 would be negative and would therefore support the corresponding hypothesis. The confidence interval bars represented in graph were visually compared to the margin of non-inferiority. No further statistical analysis was done.

7. Change in T-score for the Prosthetic Limb Users Survey of Mobility (PLUS-M) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use

   Time frame: Baseline and After 4 weeks of use

   Ability to ambulate over typical environmental obstacles is measured by the PLUS-M, using the T-score with the new MPK compared to the comparator (prescribed device). The PLUS-M is a self-report tool for assessing mobility in adults with lower limb amputation. The PLUS-M produces a T-score, which is standardized with a mean of 50 and a standard deviation of 10. Higher T-scores indicate greater mobility, with scores ranging from 17.5 to 76.6, based on responses to 44 questions. Only T-scores should be reported, as they are valid and comparable, unlike raw scores. The hypothesis being tested is that the new MPK has a 95% probability of not negatively affecting the PLUS-M score. If Visit 2 scores (using the investigational device) are higher than Visit 1 scores (using the prescribed device), the positive difference supports the hypothesis. The confidence interval bars represented in graph were visually compared to the margin of non-inferiority. No further statistical analysis was done.

8. Change in Activities-Specific Balance Confidence Score (ABC) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use

   Time frame: Baseline and After 4 weeks of use

   The ABC-scale is a 16-item questionnaire measuring confidence in performing ambulatory activities without falling, scored from 0 (no confidence) to 100 (full confidence). Cut-off scores define physical functioning: below 50% indicates low, 50-80% moderate, and above 80% high functioning. The hypothesis is that the new MPK has a 95% chance of not negatively impacting the ABC score. If Visit 2 scores (using the investigational device) exceed Visit 1 scores (using the prescribed device), it supports the hypothesis. Confidence interval bars in the graph were visually compared to the margin of non-inferiority, with no additional statistical analysis conducted.