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The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on level walking and secondarily in safety, stair and hill mobility, activities of daily living, satisfaction and preference.
During the last two decades many microprocessor controlled knee joints (MPK) appeared on the market.The newly developed C-Leg 4 aims to provide improved standing function while in the same time offering technology of knee´s previous version (C-Leg 3). Since added functional benefit of a knee joint cannot be anticipated just due to the fact that the knee is controlled by the microprocessor, the aim of this post-market study is to evaluate the safety, functional mobility and satisfaction of the microprocessor controlled prosthetic knee components C-Leg 3 and C-Leg 4 in comparison to mechanical knee joints. Additional goal is to improve the methodological quality of research conducted in the field.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-Leg 3, then C-Leg 4 | Experimental | Participants are first fitted with a C-Leg 3, receive physical therapy, acclimate for 90 days and are then assessed in the clinic. They then receive a C-Leg 4, receive additional physical therapy and acclimate for 30 days after which they are again assessed in the clinic. |
|
| C-Leg 4, then C-Leg 3 | Experimental | Participants are first fitted with a C-Leg 4, receive physical therapy, acclimate for 90 days and are then assessed in the clinic. They then receive a C-Leg 3, receive additional physical therapy and acclimate for 30 days after which they are again assessed in the clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-Leg 4 | Device | Microprocessor Controlled Knee |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6 Minute Gait Test | A measure of walking endurance, the distance walked in meters after 6 minutes. | Baseline and after acclimation period (30-90 days after fitting) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 10 Meter Gait Test | Average gait speed over middle 6 meters of a 10-meter course at both self-selected and fastest safe walking speeds | Baseline and after acclimation period (30-90 days after fitting) |
| Change in Stairs Assessment Index (SAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Domayer, Prim.Dr. | Orthopedic Rehabilitation Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Rehabilitation Center SKA Zicksee | Sankt Andrä am Zicksee | Burgenland | 7161 | Austria | ||
| University Leuven |
Data for primary and secondary outcome measures will be made available within one year of study completion.
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5 subjects were excluded from the study prior to randomization: 3 subjects had adverse events, 1 subject could not be fitted with the intervention device due to anthropomorphic characteristics, and 1 subject withdrew due to a change in work situation.
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| ID | Title | Description |
|---|---|---|
| FG000 | C-Leg 3, Then C-Leg 4 | The participants were first fitted with C-Leg 3 and allowed to accommodate for up to 90 days after which they were assessed. Then they crossed over to be fitted with the C-Leg 4 and allowed to accommodate for 30 days after which they were assessed. |
| FG001 | C-Leg 4, Then C-Leg 3 | The participants were first fitted with C-Leg 4 and allowed to accommodate for up to 90 days after which they were assessed. Then they crossed over to be fitted with the C-Leg 3 and allowed to accommodate for 30 days after which they were assessed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (90 Days) |
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| Second Intervention (30 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | C-Leg 3, Then C-Leg 4 | C-Leg 4: Microprocessor Controlled Knee C-Leg 3: Microprocessor Controlled Knee |
| BG001 | C-Leg 4, Then C-Leg 3 | C-Leg 4: Microprocessor Controlled Knee C-Leg 3: Microprocessor Controlled Knee |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in 6 Minute Gait Test | A measure of walking endurance, the distance walked in meters after 6 minutes. | Posted | Mean | Standard Deviation | meters | Baseline and after acclimation period (30-90 days after fitting) |
|
36-40 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | C-Leg 3 | The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
From 11 subjects that participated in the study, only 7 followed protocol. From post-hoc power analysis, 22 subjects would be required for 80% power to detect a difference of 35.9m (standard deviation = 30.3m) in the 6MWT.
Patients were aware that a walking speed of greater than 0.8 m/s was a prerequisite for study participation, which could have lead to bias (elevated baseline measurement) and explain the small change in observed walking speed with C-Leg 3 and C-Leg 4 compared to baseline.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research and Services Vienna | Otto Bock Healthcare GmbH | +4315233786733 | Milana.Mileusnic@Ottobock.com |
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| 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 | Dec 15, 2015 | Jul 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| C-Leg 3 | Device | Microprocessor Controlled Knee |
|
Participants are scored on a 14-level scale for independence, technique and step length for ascending and descending a 12-step ADA-compliant stairwell. The maximum score is 13 and the minimum 0. Higher scores indicate greater independence. Time to descend stairs was also recorded. |
| Baseline and after acclimation period (30-90 days after fitting) |
| Change in Hill Assessment Index (HAI) | Participants are scored on a 12-level scale for independence, technique and step length for descending a 5m, 5-degree downgrade hill at self selected speed. The maximum score is 11 and the minimum 0. Higher scores indicate greater independence. Time to descend the hill was also recorded. | Baseline and after acclimation period (30-90 days after fitting) |
| Change in Four Step Square Test (FSST) | Time to complete a stepping sequence through 4 squares as quickly as possible. The test involves stepping forward, backward and sideways to the left and right while face the same direction. | Baseline and after acclimation period (30-90 days after fitting) |
| Change in Activities-specific Balance Confidence (ABC) Scale | Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores. | Baseline and after acclimation period (30-90 days after fitting) |
| Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) | The PLUS-M 12-item short form is a valid and reliable self-reported measure for the mobility of adults with lower limb amputations. PLUS-M asks about the patient's ability to perform simple and complex tasks. Higher PLUS-M scores correspond with greater mobility. T-scores range from 21.8 to 71.4. A 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 (i.e., people with unilateral amputation). | Baseline and after acclimation period (30-90 days after fitting) |
| Change in Amputee Body Image Scale (ABIS) | The ABIS assesses how an amputee perceives and feels about his or her body experience. The scale addresses several different domains, including: 1) body appearance; 2) body function; 3effective distress; and 4) behavioral avoidance in social situations. The scale produces scores that range from 1 to 100, with low scores indicating the relative absence of a body image concern and higher scores indicating the presence of a more serious body-image concern. | Baseline and after acclimation period (30-90 days after fitting) |
| Change in Number of Stumbles and Falls | Stumbles and falls in the previous 30 days for each studied device based on records in a subject log book. At baseline, users were asked to recall the number of stumbles and falls in the previous 30 days. | Baseline and after acclimation period (30-90 days after fitting) |
| Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee) | The user´s knee preference is assessed with the question: "Which prosthesis do you prefer?" | At 3rd study visit after having been fitted and acclimatized to each of the study devices |
| Pellenberg |
| 3212 |
| Belgium |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Time since amputation | Mean | Standard Deviation | years |
|
| Amputation side | Count of Participants | Participants |
|
| Amputation type | Count of Participants | Participants |
|
| Medicare Functional Classification Level (MFCL) | The Medicare Functional Classification Level (MFCL) was adopted in 1995 by the US Centers for Medicare and Medicaid Services using 5 levels for classifying functional mobility and rehabilitation potential of individuals with lower limb loss. Level 0 does not have the ability or potential to ambulate or transfer safely. Level 1 is a household ambulator. Level 2 is a limited community ambulator. Level 3 is a community ambulator, and Level 4 has higher prosthetic demands typical of the child, active adult or athlete. | Count of Participants | Participants |
|
| Current knee prosthesis (NMPK) | Count of Participants | Participants |
|
| Amputation cause | Count of Participants | Participants |
|
| Hours of wearing prosthesis per day | Mean | Standard Deviation | hours |
|
| Distance covered per day | Mean | Standard Deviation | km |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change in 10 Meter Gait Test | Average gait speed over middle 6 meters of a 10-meter course at both self-selected and fastest safe walking speeds | Posted | Mean | Standard Deviation | meters per second | Baseline and after acclimation period (30-90 days after fitting) |
|
|
|
| Secondary | Change in Stairs Assessment Index (SAI) | Participants are scored on a 14-level scale for independence, technique and step length for ascending and descending a 12-step ADA-compliant stairwell. The maximum score is 13 and the minimum 0. Higher scores indicate greater independence. Time to descend stairs was also recorded. | Posted | Mean | Standard Deviation | score on a scale | Baseline and after acclimation period (30-90 days after fitting) |
|
|
|
| Secondary | Change in Hill Assessment Index (HAI) | Participants are scored on a 12-level scale for independence, technique and step length for descending a 5m, 5-degree downgrade hill at self selected speed. The maximum score is 11 and the minimum 0. Higher scores indicate greater independence. Time to descend the hill was also recorded. | Posted | Mean | Standard Deviation | score on a scale | Baseline and after acclimation period (30-90 days after fitting) |
|
|
|
| Secondary | Change in Four Step Square Test (FSST) | Time to complete a stepping sequence through 4 squares as quickly as possible. The test involves stepping forward, backward and sideways to the left and right while face the same direction. | Posted | Mean | Standard Deviation | seconds | Baseline and after acclimation period (30-90 days after fitting) |
|
|
|
| Secondary | Change in Activities-specific Balance Confidence (ABC) Scale | Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores. | Posted | Mean | Standard Deviation | score on a scale | Baseline and after acclimation period (30-90 days after fitting) |
|
|
|
| Secondary | Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) | The PLUS-M 12-item short form is a valid and reliable self-reported measure for the mobility of adults with lower limb amputations. PLUS-M asks about the patient's ability to perform simple and complex tasks. Higher PLUS-M scores correspond with greater mobility. T-scores range from 21.8 to 71.4. A 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 (i.e., people with unilateral amputation). | Posted | Mean | Standard Deviation | T-score | Baseline and after acclimation period (30-90 days after fitting) |
|
|
|
| Secondary | Change in Amputee Body Image Scale (ABIS) | The ABIS assesses how an amputee perceives and feels about his or her body experience. The scale addresses several different domains, including: 1) body appearance; 2) body function; 3effective distress; and 4) behavioral avoidance in social situations. The scale produces scores that range from 1 to 100, with low scores indicating the relative absence of a body image concern and higher scores indicating the presence of a more serious body-image concern. | Posted | Mean | Standard Deviation | score on a scale | Baseline and after acclimation period (30-90 days after fitting) |
|
|
|
| Secondary | Change in Number of Stumbles and Falls | Stumbles and falls in the previous 30 days for each studied device based on records in a subject log book. At baseline, users were asked to recall the number of stumbles and falls in the previous 30 days. | Posted | Mean | Standard Deviation | number of stumbles or falls | Baseline and after acclimation period (30-90 days after fitting) |
|
|
|
| Secondary | Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee) | The user´s knee preference is assessed with the question: "Which prosthesis do you prefer?" | All subjects with preference data that completed the study were included in the analysis. | Posted | Count of Participants | Participants | At 3rd study visit after having been fitted and acclimatized to each of the study devices |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 3 |
| 13 |
| EG001 | C-Leg 4 | The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation) | 0 | 13 | 0 | 13 | 3 | 13 |
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Foot pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Residual limb pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| 4 |
|
| 3R60 |
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| 3R80 |
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| Polycentric |
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| Multiaxial |
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| trauma |
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| vascular disease |
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| FWS at Baseline |
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| FWS after acclimation |
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| Baseline SAI (Descent) |
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| Change in SAI (Descent) after fitting and acclimation |
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| Baseline time to descent stairs |
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| Change in time to descent stairs after fitting and acclimation |
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| Baseline HAI (Descent) |
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| Change in HAI (Descent) after fitting and acclimation |
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| Baseline Descent Time |
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| Change in Descent Time after fitting and acclimation |
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| Baseline number of falls |
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| Change in number of falls after fitting and acclimation |
|
| Title | Measurements |
|---|---|
|