Lower Limb Amputation Above Knee (Injury)NCT02765035
C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
A study testing C-Leg 4 and C-Leg 3 in people with Lower Limb Amputation Above Knee (Injury), run by Otto Bock Healthcare Products GmbH at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation Above Knee (Injury)
- What is being tested?
- C-Leg 4 and C-Leg 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2016to 30 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Person is >18 years old.
- Person is a unilateral transfemoral or knee-disarticulation amputee with stabilized residual limb.
- Person is a K2, K3 or K4 ambulator based on Medicare Functional Classification Level (MFCL).
- Person is currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee for at least 6 months.
- Person was never fitted with microprocessor controlled prosthetic knee joint.
- Person is willing and able to independently provide informed consent.
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- Person is willing to comply with study procedures.
- Person wears prosthesis daily and ≥ 8 hours/day.
- Person is walking on average 1km/day.
- Person is walking not slower than 3km/h (~0.8m/s) (based on 10m walk test conducted during recruiting).
- Person is walking on level ground in a step over step manner.
Who cannot join
- Person is under 18 years of age.
- Person who weighs more than 136kg.
- Person who weighs less than 50kg.
- Person who is pregnant.
- Person has a history of chronic skin breakdown on the residual limb.
- Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking).
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- Person falls ≥ once a week due to the reasons that could not be corrected by the new prosthesis (for ex. problems with vestibular system).
- Person is using under arm axillary crutches or walker.
- Person in an emergency, life threatening situation.
- Person is unwilling/unable to follow instructions.
- Person who is not available to follow the entire study protocol.
- Person who is participating in another study or intends to participate in another study during this study duration.
- Person who cannot personally provide their consent.
- Person who is not wearing prosthesis 8hours/day on average.
- Person who has a score on 10m walk test less than 3km/h (~0.8m/s) (based on 10m walk test conducted during recruiting).
- Person who walks on average less than 1km per day.
- Person who is not able to walk on level ground in a step over step manner.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site
Orthopedic Rehabilitation Center SKA Zicksee
Sankt Andrä am Zicksee, Burgenland, 7161
About this study
Official title: A Randomized, Blinded, Cross-over Trial to Evaluate the Safety, Functional Mobility and Satisfaction of the Microprocessor Controlled Prosthetic Knee Component C-Leg 4 in Transfemoral Amputees
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.
Read the detailed description
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.
- Being tested
- C-Leg 4, C-Leg 3
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Leg 4Device
Microprocessor Controlled Knee
C-Leg 3Device
Microprocessor Controlled Knee
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: C-Leg 4; Device: C-Leg 3 |
| 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. Receives: Device: C-Leg 4; Device: C-Leg 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 Minute Gait Test
A measure of walking endurance, the distance walked in meters after 6 minutes.
Measured: Baseline and after acclimation period (30-90 days after fitting)
Secondary outcomes (9)
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
Measured: Baseline and after acclimation period (30-90 days after fitting)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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?"
Measured: At 3rd study visit after having been fitted and acclimatized to each of the study devices
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startApr 2016
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lower Limb Amputation Above Knee (Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otto Bock Healthcare Products GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Domayer, Prim.Dr., Principal investigator, Orthopedic Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765035
- Sponsor's protocol ID
- PD-PS00120010A-001
- Status last verified
- Sep 2021
- First submitted
- 2 May 2016
- Last updated
- 14 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data for primary and secondary outcome measures will be made available within one year of study completion.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Cross-over Trial to Evaluate the Safety, Functional Mobility and Satisfaction of the Microprocessor Controlled Prosthetic Knee Component C-Leg 4 in Transfemoral Amputees
- ClinicalTrials.gov ID
- NCT02765035
- Acronym / sponsor ID
- PD-PS00120010A-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Otto Bock Healthcare Products GmbHIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Posted 14 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-Leg 3, then C-Leg 4 | Experimental | Device: C-Leg 4, Device: C-Leg 3Participants 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 | Device: C-Leg 4, Device: C-Leg 3Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Person is >18 years old.
- Person is a unilateral transfemoral or knee-disarticulation amputee with stabilized residual limb.
- Person is a K2, K3 or K4 ambulator based on Medicare Functional Classification Level (MFCL).
- Person is currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee for at least 6 months.
- Person was never fitted with microprocessor controlled prosthetic knee joint.
Key exclusion criteria (17 listed)
- Person is under 18 years of age.
- Person who weighs more than 136kg.
- Person who weighs less than 50kg.
- Person who is pregnant.
- Person has a history of chronic skin breakdown on the residual limb.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-Leg 4Microprocessor Controlled Knee | Device | C-Leg 3, then C-Leg 4, C-Leg 4, then C-Leg 3 |
| C-Leg 3Microprocessor Controlled Knee | Device | C-Leg 3, then C-Leg 4, C-Leg 4, then C-Leg 3 |
Primary outcome
Change in 6 Minute Gait Test
Time frame: Baseline and after acclimation period (30-90 days after fitting)
A measure of walking endurance, the distance walked in meters after 6 minutes.
9 secondary outcomes
Change in 10 Meter Gait Test
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in Stairs Assessment Index (SAI)
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in Hill Assessment Index (HAI)
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in Four Step Square Test (FSST)
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in Activities-specific Balance Confidence (ABC) Scale
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in Prosthetic Limb Users Survey of Mobility (PLUS-M)
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in Amputee Body Image Scale (ABIS)
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Change in Number of Stumbles and Falls
Time frame: Baseline and after acclimation period (30-90 days after fitting)
Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee)
Time frame: At 3rd study visit after having been fitted and acclimatized to each of the study devices
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data for primary and secondary outcome measures will be made available within one year of study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Domayer, Prim.Dr. principal investigator
Orthopedic Rehabilitation Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Leg 4 and C-Leg 3 in people with Lower Limb Amputation Above Knee (Injury), run by Otto Bock Healthcare Products GmbH at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6 Minute Gait Test (time frame: Baseline and after acclimation period (30-90 days after fitting)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.