Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.
The purpose of the Revo-M Study is to characterize differences in performance and patient reported outcomes between the Revo investigational prosthetic foot and a comparative prosthetic foot (Taleo or Proflex XC) when compared to the control foot which is the subject's currently used energy storage and return (ESR) prosthetic foot. The data obtained from this study may also serve to determine the long-term performance of Revo.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revo-M to Proflex XC | Experimental | Transtibial amputees randomized to start with Revo-M and cross over to Proflex XC |
|
| Proflex XC to Revo-M | Experimental | Transtibial amputees randomized to start with Proflex XC and cross over to Revo-M |
|
| Revo-M to Taleo | Experimental | Transfemoral amputees randomized to start with Revo-M and cross over to Taleo |
|
| Taleo to Revo-M | Experimental | Transfemoral amputees randomized to start with Taleo and cross over to Revo-M |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revo-M | Device | Investigational energy storage and return prosthetic foot with using novel elastic elements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-perceived Mobility (PLUS-M)™ | 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. | baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot |
| Patient-perceived Activity Restrictions (Revised TAPES-AR Subscale) | 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. | baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Showing Improvement in Walking Endurance or Perceived Exertion in the 6-minute Walk Test | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artificial Limb Specialists | Mesa | Arizona | 85202 | United States | ||
| Dankmeyer Prosthetics & Orthotics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20489393 | Background | Gallagher P, Franchignoni F, Giordano A, MacLachlan M. Trinity amputation and prosthesis experience scales: a psychometric assessment using classical test theory and rasch analysis. Am J Phys Med Rehabil. 2010 Jun;89(6):487-96. doi: 10.1097/PHM.0b013e3181dd8cf1. | |
| 28273329 | Background | Hafner BJ, Morgan SJ, Askew RL, Salem R. Psychometric evaluation of self-report outcome measures for prosthetic applications. J Rehabil Res Dev. 2016;53(6):797-812. doi: 10.1682/JRRD.2015.12.0228. |
Not provided
Not provided
There is no plan to share IPD.
Not provided
Not provided
Not provided
Not provided
1 Subject failed screening
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Revo-M to Proflex XC | Transtibial amputees randomized to start with Revo-M and cross over to Proflex XC |
| FG001 | Proflex XC to Revo-M | Transtibial amputees randomized to start with Proflex XC and cross over to Revo-M |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2020 |
Not provided
Randomized cross-over controlled trial
Not provided
Not provided
Not provided
Not provided
| Taleo | Device | Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects |
|
| Proflex XC | Device | Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects |
|
| 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot |
| Patient Perceived Balance Confidence (ABC) | 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. | baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot |
| Functional Satisfaction With Prosthesis (TAPES-FUN) | 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. | baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot |
| Linthicum |
| Maryland |
| 21090 |
| United States |
| Optimus Prosthetics | Dayton | Ohio | 45414 | United States |
| Ability P&O | Exton | Pennsylvania | 19341 | United States |
| FG002 | Revo-M to Taleo | Transfemoral amputees randomized to start with Revo-M and cross over to Taleo |
| FG003 | Taleo to Revo-M | Transfemoral amputees randomized to start with Taleo and cross over to Revo-M |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| First Foot Assignment |
|
|
| Crossover to Alternate Foot Assignment |
|
|
| Return to Baseline Foot |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Revo-M to Proflex XC | 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 |
| BG001 | Proflex XC to Revo-M | 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 |
| BG002 | Revo-M to Taleo | 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 |
| BG003 | Taleo to Revo-M | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | centimeters |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilograms |
| |||||||||||||||
| Years since amputation | Mean | Standard Deviation | years |
| |||||||||||||||
| Amputation level | Count of Participants | Participants |
| ||||||||||||||||
| Mobility grade | K1: has ability/potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence or speed, typical of a household ambulator. K2: has ability/potential for ambulation with the ability to traverse low-level environmental barriers, typical of the limited community ambulator. K3: has ability/potential for ambulation with variable cadence or multiple speeds, typically a community ambulator . K4: has ability/potential for ambulation that exceeds basic ambulation skills, exhibiting high impact, stress or energy levels, typical of the child, active adult or athlete. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient-perceived Mobility (PLUS-M)™ | 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. | ITT analysis | Posted | Mean | Standard Deviation | units on a scale | baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Patient-perceived Activity Restrictions (Revised TAPES-AR Subscale) | 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. | ITT analysis | Posted | Mean | Standard Deviation | score on a scale | baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Showing Improvement in Walking Endurance or Perceived Exertion in the 6-minute Walk Test | 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. | ITT analysis | Posted | Count of Participants | Participants | 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Perceived Balance Confidence (ABC) | 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. | ITT analysis | Posted | Mean | Standard Deviation | score on a scale | baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Functional Satisfaction With Prosthesis (TAPES-FUN) | 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. | ITT analysis | Posted | Mean | Standard Deviation | score on a scale | baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Everyday Foot | 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. | 0 | 26 | 1 | 26 | 3 | 26 |
| EG001 | Reference Foot | The reference foot for transtibial amputees was the Pro-Flex XC. The reference foot for transfemoral amputees was the Taleo. | 0 | 22 | 1 | 22 | 7 | 22 |
| EG002 | Revo-M | 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. | 0 | 23 | 2 | 23 | 6 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal blockage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Bacterial Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injurious Fall | General disorders | Sponsor | Systematic Assessment |
| |
| Bone Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in hip | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in leg | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Peripheral neuropathy aggravated | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Knee Instability | Product Issues | Sponsor | Systematic Assessment | Only applicable to transfemoral amputees using a prosthetic knee, typically described as the joint feeling "squishy" |
|
| Loss of suction | Product Issues | Sponsor | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Open Wound | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
A small overall sample. One subject could not tolerate the Taleo foot for any amount of time and so was not assessed on the Taleo.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Ottobock SE & Co. KGaA | +4955278483054 | pawel.maciejasz@ottobock.com |
| Jan 30, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Transfemoral |
|
| K2 |
|
| K3 |
|
| K4 |
|
2-sided Wilcoxon matched pairs signed ranks test, n=23 (11 negative, 8 positive and 4 null), Z=-1.066. |
| OG003 | Final | Study assessments with the prosthetic foot used daily by the subject at baseline, after using the reference foot and Revo. |
|
|
|
| OG002 | Final | Study assessments with the prosthetic foot used daily by the subject at baseline, after using the reference foot and Revo. |
|
|
| OG003 | Final | Study assessments with the prosthetic foot used daily by the subject at baseline, after using the reference foot and Revo. |
|
|
|
| OG003 | Final | Study assessments with the prosthetic foot used daily by the subject at baseline, after using the reference foot and Revo. |
|
|
|