Trial Outcomes & Findings for Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot (NCT NCT04239222)

Last Updated: 2024-09-23

Results Overview

Perception of mobility as measured by the Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item short form. The PLUS-M questionnaire provides a T-score that ranges from 21.8 to 71.4. Higher PLUS-M scores correspond with greater mobility. The T-score has a mean of 50 and a standard deviation (SD) of 10. A PLUS-M T-score of 50 represents the mean mobility reported by the development sample. A T-score greater than 57 indicates that the mobility is above the 75th percentile.

Recruitment status

COMPLETED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

Results posted on

2024-09-23

Participant Flow

1 Subject failed screening

Participant milestones

Participant milestones
Measure	Revo-M to Proflex XC Transtibial amputees randomized to start with Revo-M and cross over to Proflex XC	Proflex XC to Revo-M Transtibial amputees randomized to start with Proflex XC and cross over to Revo-M	Revo-M to Taleo Transfemoral amputees randomized to start with Revo-M and cross over to Taleo	Taleo to Revo-M Transfemoral amputees randomized to start with Taleo and cross over to Revo-M
Baseline STARTED	6	8	4	8
Baseline COMPLETED	6	8	3	7
Baseline NOT COMPLETED	0	0	1	1
First Foot Assignment STARTED	6	8	3	7
First Foot Assignment COMPLETED	6	8	2	7
First Foot Assignment NOT COMPLETED	0	0	1	0
Crossover to Alternate Foot Assignment STARTED	6	8	2	7
Crossover to Alternate Foot Assignment COMPLETED	6	8	1	7
Crossover to Alternate Foot Assignment NOT COMPLETED	0	0	1	0
Return to Baseline Foot STARTED	6	8	2	7
Return to Baseline Foot COMPLETED	6	8	2	7
Return to Baseline Foot NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Revo-M to Taleo Transfemoral amputees randomized to start with Revo-M and cross over to Taleo	Taleo to Revo-M Transfemoral amputees randomized to start with Taleo and cross over to Revo-M
Baseline Withdrawal by Subject	1	1
First Foot Assignment Withdrawal by Subject	1	0
Crossover to Alternate Foot Assignment Protocol Violation	1	0

Baseline Characteristics

Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Revo-M to Proflex XC n=6 Participants Transtibial amputees randomized to start with Revo-M and cross over to Proflex XC Revo-M: Investigational energy storage and return prosthetic foot with using novel elastic elements. Proflex XC: Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects	Proflex XC to Revo-M n=8 Participants Transtibial amputees randomized to start with Proflex XC and cross over to Revo-M Revo-M: Investigational energy storage and return prosthetic foot with using novel elastic elements. Proflex XC: Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects	Revo-M to Taleo n=4 Participants Transfemoral amputees randomized to start with Revo-M and cross over to Taleo Revo-M: Investigational energy storage and return prosthetic foot with using novel elastic elements. Taleo: Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects	Taleo to Revo-M n=8 Participants Transfemoral amputees randomized to start with Taleo and cross over to Revo-M Revo-M: Investigational energy storage and return prosthetic foot with using novel elastic elements. Taleo: Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	15 Participants n=21 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	11 Participants n=21 Participants
Age, Continuous	64.2 years STANDARD_DEVIATION 7.9 • n=5 Participants	52.4 years STANDARD_DEVIATION 16.8 • n=7 Participants	44.8 years STANDARD_DEVIATION 9.4 • n=5 Participants	60.1 years STANDARD_DEVIATION 23.5 • n=4 Participants	56.3 years STANDARD_DEVIATION 14.0 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	21 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	22 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Height	175.0 centimeters STANDARD_DEVIATION 4.3 • n=5 Participants	170.5 centimeters STANDARD_DEVIATION 9.1 • n=7 Participants	173.5 centimeters STANDARD_DEVIATION 8.7 • n=5 Participants	176.1 centimeters STANDARD_DEVIATION 61.9 • n=4 Participants	173.7 centimeters STANDARD_DEVIATION 7.6 • n=21 Participants
Weight	88.7 kilograms STANDARD_DEVIATION 14.1 • n=5 Participants	78.0 kilograms STANDARD_DEVIATION 9.8 • n=7 Participants	81.8 kilograms STANDARD_DEVIATION 7.2 • n=5 Participants	92.1 kilograms STANDARD_DEVIATION 34.8 • n=4 Participants	85.4 kilograms STANDARD_DEVIATION 13.4 • n=21 Participants
Years since amputation	11.8 years STANDARD_DEVIATION 14.9 • n=5 Participants	12.6 years STANDARD_DEVIATION 14.8 • n=7 Participants	22.0 years STANDARD_DEVIATION 13.1 • n=5 Participants	14.9 years STANDARD_DEVIATION 16.3 • n=4 Participants	16.2 years STANDARD_DEVIATION 15.3 • n=21 Participants
Amputation level Transtibial	6 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	14 Participants n=21 Participants
Amputation level Transfemoral	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants	12 Participants n=21 Participants
Mobility grade K1	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Mobility grade K2	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Mobility grade K3	6 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants	26 Participants n=21 Participants
Mobility grade K4	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

Population: ITT analysis

Outcome measures

Outcome measures
Measure	Baseline n=24 Participants Study assessments with the prosthetic foot used daily by the subject at baseline, prior to using the reference foot or Revo.	Reference n=22 Participants The reference foot for transtibial amputees was the Pro-Flex XC. The reference foot for transfemoral amputees was the Taleo.	Revo n=23 Participants The Revo-M version FM 2.0 is an investigational foot, not yet marketed at the time of the study. The Revo-M utilizes carbon springs and polyurethane-foam bumpers as elastic elements. These elastic elements allow for a harmonic rollover during stance phase. The proximal connection to other prosthetic components is provided by the aluminum upper part, which contains a pyramid adaptor for this purpose. Furthermore, there is a pivoting joint at the center of the foot within the aluminum upper part that combines with a tension element in the heel region to form a connection to the elastic elements of the foot.	Final n=23 Participants Study assessments with the prosthetic foot used daily by the subject at baseline, after using the reference foot and Revo.
Patient-perceived Mobility (PLUS-M)™	57.2 units on a scale Standard Deviation 6.6	56.9 units on a scale Standard Deviation 7.4	58.3 units on a scale Standard Deviation 7.2	57.6 units on a scale Standard Deviation 7.1

PRIMARY outcome

Timeframe: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

Population: ITT analysis

Activity restrictions as measured by the Revised Trinity Amputation and Prosthesis Experience Scales Activity Restrictions subscale (TAPES-AR). The TAPES-AR subscale has 10 items on a three-point scale and the average score ranges from 0 to 2. A higher score indicates greater activity restriction.

Outcome measures

Outcome measures
Measure	Baseline n=24 Participants Study assessments with the prosthetic foot used daily by the subject at baseline, prior to using the reference foot or Revo.	Reference n=22 Participants The reference foot for transtibial amputees was the Pro-Flex XC. The reference foot for transfemoral amputees was the Taleo.	Revo n=23 Participants The Revo-M version FM 2.0 is an investigational foot, not yet marketed at the time of the study. The Revo-M utilizes carbon springs and polyurethane-foam bumpers as elastic elements. These elastic elements allow for a harmonic rollover during stance phase. The proximal connection to other prosthetic components is provided by the aluminum upper part, which contains a pyramid adaptor for this purpose. Furthermore, there is a pivoting joint at the center of the foot within the aluminum upper part that combines with a tension element in the heel region to form a connection to the elastic elements of the foot.	Final n=23 Participants Study assessments with the prosthetic foot used daily by the subject at baseline, after using the reference foot and Revo.
Patient-perceived Activity Restrictions (Revised TAPES-AR Subscale)	0.653 score on a scale Standard Deviation 0.362	0.686 score on a scale Standard Deviation 0.432	0.569 score on a scale Standard Deviation 0.399	0.674 score on a scale Standard Deviation 0.388

SECONDARY outcome

Timeframe: 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

Population: ITT analysis

The percentage of subjects showing an improvement compared to baseline walking endurance as measured by the distance walked in the six minute walk test OR a decrease in the rating of perceived exertion (RPE) as measured by Borg CR100 while wearing the Revo-M. A clinically-significant improvement in the 6MWT is defined as a change in distance of greater than 45 meters. A clinically-significant improvement in the RPE is defined as a change greater than 10 points. The Borg CR100 scale has a minimum of 0 and a maximum of 100. Greater scores indicate higher perceived exertion.

Outcome measures

Outcome measures
Measure	Baseline n=22 Participants Study assessments with the prosthetic foot used daily by the subject at baseline, prior to using the reference foot or Revo.	Reference n=23 Participants The reference foot for transtibial amputees was the Pro-Flex XC. The reference foot for transfemoral amputees was the Taleo.	Revo n=23 Participants The Revo-M version FM 2.0 is an investigational foot, not yet marketed at the time of the study. The Revo-M utilizes carbon springs and polyurethane-foam bumpers as elastic elements. These elastic elements allow for a harmonic rollover during stance phase. The proximal connection to other prosthetic components is provided by the aluminum upper part, which contains a pyramid adaptor for this purpose. Furthermore, there is a pivoting joint at the center of the foot within the aluminum upper part that combines with a tension element in the heel region to form a connection to the elastic elements of the foot.	Final Study assessments with the prosthetic foot used daily by the subject at baseline, after using the reference foot and Revo.
Percentage of Subjects Showing Improvement in Walking Endurance or Perceived Exertion in the 6-minute Walk Test	11 Participants	8 Participants	10 Participants	—

SECONDARY outcome

Timeframe: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

Population: ITT analysis

Perception of balance confidence as measured by the extended Activities-specific Balance Confidence (ABC) Scale. The questionnaire provides a score that ranges from 0 to 100%. Higher scores indicate greater balance confidence.

Outcome measures

Outcome measures
Measure	Baseline n=24 Participants Study assessments with the prosthetic foot used daily by the subject at baseline, prior to using the reference foot or Revo.	Reference n=22 Participants The reference foot for transtibial amputees was the Pro-Flex XC. The reference foot for transfemoral amputees was the Taleo.	Revo n=23 Participants The Revo-M version FM 2.0 is an investigational foot, not yet marketed at the time of the study. The Revo-M utilizes carbon springs and polyurethane-foam bumpers as elastic elements. These elastic elements allow for a harmonic rollover during stance phase. The proximal connection to other prosthetic components is provided by the aluminum upper part, which contains a pyramid adaptor for this purpose. Furthermore, there is a pivoting joint at the center of the foot within the aluminum upper part that combines with a tension element in the heel region to form a connection to the elastic elements of the foot.	Final n=23 Participants Study assessments with the prosthetic foot used daily by the subject at baseline, after using the reference foot and Revo.
Patient Perceived Balance Confidence (ABC)	86.8 score on a scale Standard Deviation 8.9	86.2 score on a scale Standard Deviation 11.3	87.7 score on a scale Standard Deviation 11.2	86.9 score on a scale Standard Deviation 10.9

SECONDARY outcome

Timeframe: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

Population: ITT analysis

To characterize the level of functional satisfaction as measured by the TAPES Functional Satisfaction (TAPES-FUN) subscale while wearing a given prosthetic foot. There are 5 items scaled from 1 to 5. The subscale provides a total score that ranges from 5 to 25. Higher scores indicate greater functional satisfaction.

Outcome measures

Outcome measures
Measure	Baseline n=24 Participants Study assessments with the prosthetic foot used daily by the subject at baseline, prior to using the reference foot or Revo.	Reference n=22 Participants The reference foot for transtibial amputees was the Pro-Flex XC. The reference foot for transfemoral amputees was the Taleo.	Revo n=23 Participants The Revo-M version FM 2.0 is an investigational foot, not yet marketed at the time of the study. The Revo-M utilizes carbon springs and polyurethane-foam bumpers as elastic elements. These elastic elements allow for a harmonic rollover during stance phase. The proximal connection to other prosthetic components is provided by the aluminum upper part, which contains a pyramid adaptor for this purpose. Furthermore, there is a pivoting joint at the center of the foot within the aluminum upper part that combines with a tension element in the heel region to form a connection to the elastic elements of the foot.	Final n=23 Participants Study assessments with the prosthetic foot used daily by the subject at baseline, after using the reference foot and Revo.
Functional Satisfaction With Prosthesis (TAPES-FUN)	21.6 score on a scale Standard Deviation 4.3	21.5 score on a scale Standard Deviation 3.2	22.1 score on a scale Standard Deviation 2.3	20.4 score on a scale Standard Deviation 4.6

Adverse Events

Everyday Foot

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Reference Foot

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Revo-M

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Everyday Foot n=26 participants at risk The prosthetic foot used daily by the subject at baseline. Due to the ABCA crossover design, subjects would be expected to spend nearly double the amount of time in this group.	Reference Foot n=22 participants at risk The reference foot for transtibial amputees was the Pro-Flex XC. The reference foot for transfemoral amputees was the Taleo.	Revo-M n=23 participants at risk The Revo-M version FM 2.0 is an investigational foot, not yet marketed at the time of the study. The Revo-M utilizes carbon springs and polyurethane-foam bumpers as elastic elements. These elastic elements allow for a harmonic rollover during stance phase. The proximal connection to other prosthetic components is provided by the aluminum upper part, which contains a pyramid adaptor for this purpose. Furthermore, there is a pivoting joint at the center of the foot within the aluminum upper part that combines with a tension element in the heel region to form a connection to the elastic elements of the foot.
Gastrointestinal disorders Intestinal blockage	3.8% 1/26 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/22 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/23 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Infections and infestations Bacterial Infection	0.00% 0/26 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/22 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	4.3% 1/23 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Infections and infestations COVID-19	0.00% 0/26 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	4.5% 1/22 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/23 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Surgical and medical procedures Cholecystectomy	0.00% 0/26 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/22 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	4.3% 1/23 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.

Other adverse events

Other adverse events
Measure	Everyday Foot n=26 participants at risk The prosthetic foot used daily by the subject at baseline. Due to the ABCA crossover design, subjects would be expected to spend nearly double the amount of time in this group.	Reference Foot n=22 participants at risk The reference foot for transtibial amputees was the Pro-Flex XC. The reference foot for transfemoral amputees was the Taleo.	Revo-M n=23 participants at risk The Revo-M version FM 2.0 is an investigational foot, not yet marketed at the time of the study. The Revo-M utilizes carbon springs and polyurethane-foam bumpers as elastic elements. These elastic elements allow for a harmonic rollover during stance phase. The proximal connection to other prosthetic components is provided by the aluminum upper part, which contains a pyramid adaptor for this purpose. Furthermore, there is a pivoting joint at the center of the foot within the aluminum upper part that combines with a tension element in the heel region to form a connection to the elastic elements of the foot.
General disorders Injurious Fall	0.00% 0/26 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/22 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	4.3% 1/23 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Infections and infestations Bone Infection	3.8% 1/26 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/22 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/23 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Infections and infestations COVID-19	0.00% 0/26 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/22 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	4.3% 1/23 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/26 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	4.5% 1/22 • Number of events 2 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	4.3% 1/23 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Musculoskeletal and connective tissue disorders Muscle Pain	0.00% 0/26 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	4.5% 1/22 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/23 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Musculoskeletal and connective tissue disorders Pain in hip	0.00% 0/26 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	4.5% 1/22 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/23 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Musculoskeletal and connective tissue disorders Pain in leg	0.00% 0/26 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/22 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	4.3% 1/23 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Nervous system disorders Peripheral neuropathy aggravated	3.8% 1/26 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/22 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/23 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Product Issues Knee Instability	0.00% 0/26 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	13.6% 3/22 • Number of events 3 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	4.3% 1/23 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Product Issues Loss of suction	0.00% 0/26 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/22 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	4.3% 1/23 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Renal and urinary disorders Chronic kidney disease	0.00% 0/26 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	4.5% 1/22 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/23 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Skin and subcutaneous tissue disorders Open Wound	0.00% 0/26 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/22 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	4.3% 1/23 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.
Vascular disorders Hypertension	3.8% 1/26 • Number of events 1 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/22 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.	0.00% 0/23 • Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks. For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155. Due to the expected low rates for adverse events, it was pre-specified to combine adverse events recorded during the Baseline arm with the Everyday Foot with those reported in the Final arm after return to the Everyday Foot.

Additional Information

Clinical Project Manager

Ottobock SE & Co. KGaA

Phone: +4955278483054

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60