Other and Unspecified Complications of Amputation StumpNCT01473992
Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
A study testing Otto Bock C-Leg and Otto Bock Genium in people with Other and Unspecified Complications of Amputation Stump, run by Jason Highsmith at 1 site in United States.
Trial summary
The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former C-Leg knee prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Other and Unspecified Complications of Amputation Stump
- What is being tested?
- Otto Bock C-Leg and Otto Bock Genium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Feb 2013
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilateral transfemoral or knee-disarticulation amputee
- 18 to 85 years of age
- K3 (variable cadence and community) ambulators;
- Current use of and experience with the C-Leg for at least 1 year
- Ability to descend stairs and hills without caregiver and assistive devices
- Be able to independently provide informed consent
- Be willing to comply with study procedures.
Who cannot join
- History of chronic skin breakdown on the residual limb
- Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
- Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
- Unwillingness/inability to follow instructions
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former C-Leg knee prosthesis.
- Being tested
- Otto Bock C-Leg, Otto Bock Genium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otto Bock C-LegDevice
Amputees' preferred prosthetic knee.
Otto Bock GeniumDevice
Study knee.
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic knee 1 (Otto Bock C-Leg) | Active comparator | This arm included unilateral transfemoral amputees who were assessed while using their preferred knee at study start(C-Leg). The Otto Bock C-Leg is a microprocessor knee using 2 sensors (1 for kinetics and 1 for kinematics). Receives: Device: Otto Bock C-Leg |
| Prosthetic knee 2 (Otto Bock Genium) | Active comparator | This arm included unilateral transfemoral amputees who were assessed while using the experimental/study knee, the Genium. The Otto Bock Genium is a microprocessor knee using multiple sensors that hypothetically increase mobility functions (e.g. walking backwards, intuitive stance) Receives: Device: Otto Bock Genium |
| Non-amputee controls | No intervention | This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
75 Meter Self Selected Walking Test
Time to Complete a 75 meter walking distance.
Measured: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Physical Functional Performance (Continuous Scale; 10-items)
Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.
Measured: Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.
Secondary outcomes (2)
Balance and Stability
Balance and stability will be assessed for limits of stability using the Biodex SD. The limit of stability score is a scaled score with a possible range of 0 (worst possible outcome) to 100 (best possible outcome)based on variability of the trajectory of the center of mass while weight shifting on a force platform.
Measured: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Prosthesis Evaluation Questionnaire: Utility Score.
The Prosthetics Evaluation Questionnaire (PEQ) was used as a validated survey to solicit participants' subjective experience and feedback regarding prosthesis-related function and quality of life. PEQ domains are ordinally scaled from 0 (worst or most negative feeling/response) to 7 (best or most positive feeling/response).
Measured: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2013
- Study completionFeb 2013
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 Other and Unspecified Complications of Amputation StumpStudies 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
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jason Highsmith
- Sponsor type
- University, hospital or other
- Collaborators
- Otto Bock Healthcare, Florida High Tech Corridor Council
- Responsible party
- Sponsor-investigator, Jason Highsmith, University of South Florida
- Investigators
- M. Jason Highsmith, PT,DPT,CP, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473992
- Sponsor's protocol ID
- 6140101200
- Status last verified
- Dec 2023
- First submitted
- 31 May 2011
- Last updated
- 12 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
- ClinicalTrials.gov ID
- NCT01473992
- Acronym / sponsor ID
- 6140101200
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Jason HighsmithUniversity, hospital or other
- Collaborators
- Otto Bock Healthcare, Florida High Tech Corridor Council
- Study start
- Jan 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Posted 18 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former C-Leg knee prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prosthetic knee 1 (Otto Bock C-Leg) | Active comparator | Device: Otto Bock C-LegThis arm included unilateral transfemoral amputees who were assessed while using their preferred knee at study start(C-Leg). The Otto Bock C-Leg is a microprocessor knee using 2 sensors (1 for kinetics and 1 for kinematics). |
| Prosthetic knee 2 (Otto Bock Genium) | Active comparator | Device: Otto Bock GeniumThis arm included unilateral transfemoral amputees who were assessed while using the experimental/study knee, the Genium. The Otto Bock Genium is a microprocessor knee using multiple sensors that hypothetically increase mobility functions (e.g. walking backwards, intuitive stance) |
| Non-amputee controls | No intervention | –This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Unilateral transfemoral or knee-disarticulation amputee
- 18 to 85 years of age
- K3 (variable cadence and community) ambulators;
- Current use of and experience with the C-Leg for at least 1 year
- Ability to descend stairs and hills without caregiver and assistive devices
Key exclusion criteria (4 listed)
- History of chronic skin breakdown on the residual limb
- Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
- Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
- Unwillingness/inability to follow instructions
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 |
|---|---|---|
| Otto Bock C-LegAmputees' preferred prosthetic knee. | Device | Prosthetic knee 1 (Otto Bock C-Leg) |
| Otto Bock GeniumStudy knee. | Device | Prosthetic knee 2 (Otto Bock Genium) |
Primary outcome
75 Meter Self Selected Walking Test
Time frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Time to Complete a 75 meter walking distance.
Physical Functional Performance (Continuous Scale; 10-items)
Time frame: Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.
Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.
2 secondary outcomes
Balance and Stability
Time frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Prosthesis Evaluation Questionnaire: Utility Score.
Time frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
M. Jason Highsmith, PT,DPT,CP principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otto Bock C-Leg and Otto Bock Genium in people with Other and Unspecified Complications of Amputation Stump, run by Jason Highsmith at 1 site in United States.
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 7 inclusion and 4 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 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 18 Nov 2014). 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?
75 Meter Self Selected Walking Test (time frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.). The study lists 2 primary outcomes in all. 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 12 Dec 2023.