AmputationNCT00421356
Comparison of Prosthetic Knee Performance During Sitting and Standing
An observational study of Amputation, run by University of South Florida at 1 site in United States.
Trial summary
The Ossur Prosthetic Power Knee claims to assist in helping people with transfemoral amputation to walk up stairs and stand up from sitting. We expect to find that this product has the ability to help unload the sound knee during these tasks. We plan to collect force and motion data while people stand up from a chair. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to 30 Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Persons with Transfemoral Amputation
Who may be able to join
- 7 control subjects with normal lower extremity function: mentally independent adults with intact extremities. These individuals shall have no significant medical history that would impair their ability to perform 3, repeated, sit to stand trials. Exclusionary examples might include history positive for total joint arthroplasty of the hip or knee and significant cardiomyopathy. Control subjects will be non-amputee, generally healthy individuals, mentally capable of providing informed consent. They will have no significant medical history that could be perceived by investigators to hinder the ability to transfer. Anyone not meeting these criteria cannot be a control subject.
- 28 subjects with unilateral amputation at the level of the thigh. 7 each in four groups:
- Active Extension Group: Power Knee
- Microprocessor Stance Control Group: C-Leg, Rheo, Adaptive
- Non-Microprocessor Stance Control Group: Mauch, Catech or other stance control units
- Non-Microprocessor and Non-Stance Control units: WASB, polycentrics, pneumatics Each subject must have a prosthesis for which they have had for a minimum of 90 days in its present condition.
Show all 10Show fewer
- All subjects must be:
- at least 21 years of age,
- mentally independent, and
- able to give informed consent.
Who cannot join
- Subjects are not candidates if they:
- are under 21 years of age
- are mentally dependent and unable to provide their own informed consent
- have worn the present prosthesis for less than 90 days in the current condition
- have bilateral amputation
- Subjects with an amputation are not candidates if they only use a prosthesis for transfers or therapy (K0 or K1 Medicare functional class). They must be independently ambulatory, at some level in the community (Medicare functional class "K2-K4"). They are furthermore not a candidate for this study if they have bilateral amputation (at any level) of the lower extremity as the purpose is to determine sound versus involved side loading, then against control. If all of the latter criteria are satisfied, the final piece is the 90 day prosthetic accommodation period. Candidacy then hinges upon the fact that they are accommodated to their current prosthesis as evident by having worn the current device, unaltered for the 90 days prior to testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinetic and Kinematic Comparison of Power Assisted Versus Stance Control Artificial Knees During Sit To Stand
The Ossur Prosthetic Power Knee claims to assist in helping people with transfemoral amputation to walk up stairs and stand up from sitting. We expect to find that this product has the ability to help unload the sound knee during these tasks. We plan to collect force and motion data while people stand up from a chair. We will compare the data from people using several types of prosthetic knees, including the power knee as well as from people who are not amputees to see what the force and motion contributions are from the different knees evaluated.
- Conditions
- Amputation
- Keywords
- amputation, transfemoral, lower extremity, prosthetic knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transfemoral Power Knee group | Transfemoral amputees who used the power assisted Ossur Power Knee who used the knee daily without adjustments for at least 90 days prior to the study. | |
| Transfemoral C-Leg knee group | Transfemoral amputees who used the stance control Otto Bock C-Leg who used the knee daily without adjustments for at least 90 days prior to the study. | |
| Transfemoral Mauch knee group | Transfemoral amputees who used the mechanical fluid controlled Mauch Swing and Stance Knee who used the knee daily without adjustments for at least 90 days prior to the study. | |
| Non amputee control group | Healthy, non-amputee control group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startJan 2007
- Primary completion30 Sep 2010
- Study completion30 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Highsmith, University of South Florida
- Investigators
- M. Jason Highsmith, DPT, CP, Principal investigator, USF School of Physical Therapy & Rehab Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421356
- Sponsor's protocol ID
- 104850
- Other IDs
- US DOE RSA Award # H235J050020
- Status last verified
- Dec 2023
- First submitted
- 10 Jan 2007
- Last updated
- 14 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetic and Kinematic Comparison of Power Assisted Versus Stance Control Artificial Knees During Sit To Stand
- ClinicalTrials.gov ID
- NCT00421356
- Acronym / sponsor ID
- 104850
- Conditions
- Amputation
- Keywords
- amputation, transfemoral, lower extremity, prosthetic knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- 30 Sep 2010 (actual)
- Study completion
- 30 Nov 2010 (actual)
- First posted
- 12 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Ossur Prosthetic Power Knee claims to assist in helping people with transfemoral amputation to walk up stairs and stand up from sitting. We expect to find that this product has the ability to help unload the sound knee during these tasks. We plan to collect force and motion data while people stand up from a chair. We will compare the data from people using several types of prosthetic knees, including the power knee as well as from people who are not amputees to see what the force and motion contributions are from the different knees evaluated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transfemoral Power Knee group | – | –Transfemoral amputees who used the power assisted Ossur Power Knee who used the knee daily without adjustments for at least 90 days prior to the study. |
| Transfemoral C-Leg knee group | – | –Transfemoral amputees who used the stance control Otto Bock C-Leg who used the knee daily without adjustments for at least 90 days prior to the study. |
| Transfemoral Mauch knee group | – | –Transfemoral amputees who used the mechanical fluid controlled Mauch Swing and Stance Knee who used the knee daily without adjustments for at least 90 days prior to the study. |
| Non amputee control group | – | –Healthy, non-amputee control group |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with Transfemoral Amputation
Key inclusion criteria (10 listed)
- 7 control subjects with normal lower extremity function: mentally independent adults with intact extremities. These individuals shall have no significant medical history that would impair their ability to perform 3, repeated, sit to stand trials. Exclusionary examples might include history positive for total joint arthroplasty of the hip or knee and significant cardiomyopathy. Control subjects will be non-amputee, generally healthy individuals, mentally capable of providing informed consent. They will have no significant medical history that could be perceived by investigators to hinder the ability to transfer. Anyone not meeting these criteria cannot be a control subject.
- 28 subjects with unilateral amputation at the level of the thigh. 7 each in four groups:
- All subjects must be:
Key exclusion criteria (6 listed)
- Subjects are not candidates if they:
- Subjects with an amputation are not candidates if they only use a prosthesis for transfers or therapy (K0 or K1 Medicare functional class). They must be independently ambulatory, at some level in the community (Medicare functional class "K2-K4"). They are furthermore not a candidate for this study if they have bilateral amputation (at any level) of the lower extremity as the purpose is to determine sound versus involved side loading, then against control. If all of the latter criteria are satisfied, the final piece is the 90 day prosthetic accommodation period. Candidacy then hinges upon the fact that they are accommodated to their current prosthesis as evident by having worn the current device, unaltered for the 90 days prior to testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
Related trials for Amputation
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
Recruiting
Hand Prosthesis Usability and Performance
Amputation
Recruiting
E-Socket, Diagnostic Monitoring
Trans-Tibial Amputation
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
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, DPT, CP principal investigator
USF School of Physical Therapy & Rehab Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, run by University of South Florida 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 10 inclusion and 6 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 Dec 2023.