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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-22-08-040306 | Other Identifier | European database on medical devices (EUDAMED) |
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| Name | Class |
|---|---|
| Ottobock SE & Co. KGaA | UNKNOWN |
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The objective of this study is to characterize the extent of 1C70 meeting the amputees needs in comparison with their everyday and a comparator foot, in regards of daily activities, mobility and balance, as well as quality of life and pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1C70 to Pro-Flex XC | Experimental | Transtibial amputees randomized to start with 1C70 and cross over to Pro-Flex XC |
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| Pro-Flex XC to 1C70 | Experimental | Transtibial amputees randomized to start with Pro-Flex XC and cross over to 1C70 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1C70 | Device | Investigational energy storage and return prosthetic foot with using novel elastic elements. |
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| Measure | Description | Time Frame |
|---|---|---|
| Extent of meeting amputees prosthetic foot needs: 1C70 vs everyday foot | The extent of meeting amputees prosthetic foot needs by 1C70 as measured by a single question with a 0 to 10 scale compared to the same score for everyday foot. Higher score correspond with higher extent of meeting amputees prosthetic foot needs. | 2 months after fitting with the last study feet |
| Extent of meeting amputees prosthetic foot needs: 1C70 vs comparator foot | The extent of meeting amputees prosthetic foot needs by 1C70 as measured by a single question with a 0 to 10 scale compared to the same score for comparator foot. Higher score correspond with higher extent of meeting amputees prosthetic foot needs. | 2 months after fitting with the last study feet |
| Change in patient-perceived mobility (PLUS-M) compared to baseline | The change from baseline 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. | Baseline measurement vs 2 months after fitting with 1C70 |
| Change in patient-perceived mobility (PLUS-M) compared to the comparator foot | The change from baseline 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. | 2 months after fitting with each of the study feet |
| Highest pain reported: 1C70 vs everyday foot | The level of pain as a highest pain during preceding 7 days reported on a 0 ("No pain at all") to 10 ("the most intense pain imaginable") scale for the following origins: residual limb, sound limb, back, shoulder & neck area, phantom limb pain, while wearing the 1C70 foot compared to the everyday foot. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in patient perceived balance confidence (ABC) compared to baseline: 1C70 vs everyday foot | Perception of balance confidence as measured by the Activities-specific Balance Confidence (ABC) Scale. The questionnaire provides a score that ranges from 0 to 100%. Higher scores indicate greater balance confidence. | Baseline measurement vs 2 months after fitting with 1C70 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentrum für Healthcare Technology der Privaten Hochschule Göttingen (ZHT PFH) | Göttingen | Germany | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29414988 | Background | Morgan SJ, McDonald CL, Halsne EG, Cheever SM, Salem R, Kramer PA, Hafner BJ. Laboratory- and community-based health outcomes in people with transtibial amputation using crossover and energy-storing prosthetic feet: A randomized crossover trial. PLoS One. 2018 Feb 7;13(2):e0189652. doi: 10.1371/journal.pone.0189652. eCollection 2018. | |
| 39630588 |
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There is no plan to share IPD.
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Randomized cross-over controlled trial
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| Pro-Flex XC | Device | Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects. |
|
| Baseline measurement vs 2 months after fitting with 1C70 |
| Highest pain reported: 1C70 vs comparator foot | The level of pain as a highest pain during preceding 7 days reported on a 0 ("No pain at all") to 10 ("the most intense pain imaginable") scale for the following origins: residual limb, sound limb, back, shoulder & neck area, phantom limb pain, while wearing the 1C70 foot compared to the coparator foot. | 2 months after fitting with each of the study feet |
| Change in patient perceived balance confidence (ABC) compared to baseline: 1C70 vs comparator foot | Perception of balance confidence as measured by the Activities-specific Balance Confidence (ABC) Scale. The questionnaire provides a score that ranges from 0 to 100%. Higher scores indicate greater balance confidence. | 2 months after fitting with each of the study feet |
| Quality of life as measured by the EQ-5D-5L: 1C70 vs everyday foot | Measure of health status composed of 5 dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, anxiety and depression. Each dimension is rated on a 5-point scale indicating the level of perceived problems for each dimension (level 1 indicating no problems and level 5 indicating extreme problems). Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. These weights, sometimes referred to as 'utilities', are often used to compute QALYs for use in health economic analyses. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. | Baseline measurement vs 2 months after fitting with 1C70 |
| Quality of life as measured by the EQ-5D-5L: 1C70 vs comparator foot | Measure of health status composed of 5 dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, anxiety and depression. Each dimension is rated on a 5-point scale indicating the level of perceived problems for each dimension (level 1 indicating no problems and level 5 indicating extreme problems). Each health state can potentially be assigned a summary index score based on societal preference weights for the health state. These weights, sometimes referred to as 'utilities', are often used to compute QALYs for use in health economic analyses. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. | 2 months after fitting with each of the study feet |
| Pain interference: 1C70 vs everyday foot | Perception of pain interference on the usual activities as measured by a single question with a 0 ("Does not interfere") to 10 ("Completely interferes") scale. | Baseline measurement vs 2 months after fitting with 1C70 |
| Pain interference: 1C70 vs comparator foot | Perception of pain interference on the usual activities as measured by a single question with a 0 ("Does not interfere") to 10 ("Completely interferes") scale. | 2 months after fitting with each of the study feet |
| Foot preference overall and for use in several specific activities | Foot preference overall and for use in several specific activities as measured by a questionnaire from the publication of Morgan et al. (Morgan et al. 2018) | 2 months after fitting with the last study feet |
| John+Bamberg |
| Hanover |
| Germany |
| Pohlig Heidelberg | Heidelberg | Germany |
| UKM ProTec | Münster | Germany |
| Pohlig Nürnberg | Nuremberg | Germany |
| Pohlig Traunstein | Traunstein | Germany |
| Maciejasz P, Budny T, Sauer M, Umari M, Korber J, Ernst J, Altenburg B, Hahn A, Braatz F. User preference and patient benefits of a novel energy storing and return foot: A randomized, cross-over clinical trial. Prosthet Orthot Int. 2025 Dec 1;49(6):645-653. doi: 10.1097/PXR.0000000000000415. Epub 2024 Dec 4. |