Transfemoral AmputationNCT05831696
Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss
A study of Transfemoral Amputation, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this industry-initiated research study is to test that a powered microprocessor controlled knee improves metabolic function during walking in level and sloped conditions as compared to the subject's physician prescribed prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transfemoral Amputation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females with unilateral knee disarticulation or transfemoral (KD/TF) amputation.
- a body mass greater than 49Kg and less than 117Kg
- 18-75 years of age
- Have an ambulation potential of K3 or K4
- Use a prosthesis daily for walking or sports activities
- No less than six months of experience with a prosthesis
- No socket issues or changes in the last six weeks
- No residual limb pain affecting functional ability.
Who cannot join
- Cannot walk at different speeds (MCFL K0-K2)
- Limb-loss below the knee or through the hip
- More than one amputation.
- Uses an assistive device for walking
- Uncontrolled edema in leg compartments
- Compromised skin of the residual limb or contralateral foot
- Are 180 days or less post-amputation
- Pregnant (self-reported)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda University
Loma Linda, California, 92354
Michael Davidson, Ph.D., 909-558-6516, mdavidson@llu.edu
About this study
The purpose of this industry-initiated research study is to test that a powered microprocessor controlled knee improves metabolic function during walking in level and sloped conditions as compared to the subject's physician prescribed prosthesis.
Read the detailed description
The Procedures include:
Initial Visit:
- Informed consent
- HIPAA authorization
- Determine/verify ambulation potential
- Take and record body measurements (height, weight, circumferences)
- Activities-Specific Balance Confidence (ABC) scale
- L.A.S.A.R. Posture alignment assessment with RxPx
Second Visit
- Fit with heartrate monitor and metabolic analyzer mask
- Treadmill Test (level-ground) with RxPx
- Rest
- Treadmill Test (incline) with RxPx
- Fit subject with PMPK
- L.A.S.A.R. Posture alignment assessment with PMPK
- Subject uses PMPK for one week as their primary prosthesis
Third Visit (1 week later)
- Fit with heartrate monitor and metabolic analyzer mask
- Treadmill Test (level-ground) with PMPK
- Rest
- Treadmill Test (incline) with PMPK
- Activities-Specific Balance Confidence (ABC) scale
- Return PMPK and refit of RxPx
- Verify alignment with L.A.S.A.R. Posture alignment
- Check that all fasteners are secure
- Conditions
- Transfemoral Amputation
- Being tested
- Powered Microprocessor-controlled Knee (PMPK)
- Keywords
- Power Knee, Amputation, Metabolic Costs, Heart Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered Microprocessor-controlled Knee (PMPK)Other
Also called Power Knee
A microprocessor-controlled Knee with standardized commercial prosthetic foot
| Study group | Role | What they receive |
|---|---|---|
| Powered Microprocessor-controlled Knee (PMPK) | Experimental | the "Power Knee" is a commercially available PMPK. Receives: Other: Powered Microprocessor-controlled Knee (PMPK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 uptake - level ground
VO2 uptake during ambulation on a treadmill - level ground
Measured: Change between Baseline Visit (study enrollment) and Visit 2 (3 weeks post-study enrollment)
VO2 uptake - incline
VO2 uptake during ambulation on a treadmill - 5 degree incline
Measured: Visit 2 (3 weeks post-study enrollment)
Secondary outcomes (2)
Balance confidence
Activities based balance confidence survey (0-100%) higher score means more balance confidence
Measured: At Baseline Visit (study enrollment)
Exertion
Borg Exertion Scale (0-10) with 10 being maximum exertion
Measured: Change between Visit 2 (3 weeks post-study enrollment) and Visit 3 (4 weeks post-study enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start27 Feb 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfemoral AmputationStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be their own control
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Össur Iceland ehf
- Responsible party
- Sponsor
- Investigators
- Michael Davidson, Ph.D., Principal investigator, Loma Linda University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831696
- Sponsor's protocol ID
- 5220320
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss
- ClinicalTrials.gov ID
- NCT05831696
- Acronym / sponsor ID
- 5220320
- Conditions
- Transfemoral Amputation
- Keywords
- Power Knee, Amputation, Metabolic Costs, Heart Rate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Össur Iceland ehf
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Apr 2023 (actual)
- 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 purpose of this industry-initiated research study is to test that a powered microprocessor controlled knee improves metabolic function during walking in level and sloped conditions as compared to the subject's physician prescribed prosthesis.
Detailed description
The Procedures include:
Initial Visit:
- Informed consent
- HIPAA authorization
- Determine/verify ambulation potential
- Take and record body measurements (height, weight, circumferences)
- Activities-Specific Balance Confidence (ABC) scale
- L.A.S.A.R. Posture alignment assessment with RxPx
Second Visit
- Fit with heartrate monitor and metabolic analyzer mask
- Treadmill Test (level-ground) with RxPx
- Rest
- Treadmill Test (incline) with RxPx
- Fit subject with PMPK
- L.A.S.A.R. Posture alignment assessment with PMPK
- Subject uses PMPK for one week as their primary prosthesis
Third Visit (1 week later)
- Fit with heartrate monitor and metabolic analyzer mask
- Treadmill Test (level-ground) with PMPK
- Rest
- Treadmill Test (incline) with PMPK
- Activities-Specific Balance Confidence (ABC) scale
- Return PMPK and refit of RxPx
- Verify alignment with L.A.S.A.R. Posture alignment
- Check that all fasteners are secure
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be their own control
| Arm | Type | Receives |
|---|---|---|
| Powered Microprocessor-controlled Knee (PMPK) | Experimental | Other: Powered Microprocessor-controlled Knee (PMPK)the "Power Knee" is a commercially available PMPK. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and Females with unilateral knee disarticulation or transfemoral (KD/TF) amputation.
- a body mass greater than 49Kg and less than 117Kg
- 18-75 years of age
- Have an ambulation potential of K3 or K4
- Use a prosthesis daily for walking or sports activities
Key exclusion criteria (8 listed)
- Cannot walk at different speeds (MCFL K0-K2)
- Limb-loss below the knee or through the hip
- More than one amputation.
- Uses an assistive device for walking
- Uncontrolled edema in leg compartments
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 |
|---|---|---|
| Powered Microprocessor-controlled Knee (PMPK)Also: Power KneeA microprocessor-controlled Knee with standardized commercial prosthetic foot | Other | Powered Microprocessor-controlled Knee (PMPK) |
Primary outcome
VO2 uptake - level ground
Time frame: Change between Baseline Visit (study enrollment) and Visit 2 (3 weeks post-study enrollment)
VO2 uptake during ambulation on a treadmill - level ground
VO2 uptake - incline
Time frame: Visit 2 (3 weeks post-study enrollment)
VO2 uptake during ambulation on a treadmill - 5 degree incline
2 secondary outcomes
Balance confidence
Time frame: At Baseline Visit (study enrollment)
Exertion
Time frame: Change between Visit 2 (3 weeks post-study enrollment) and Visit 3 (4 weeks post-study enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
Related trials for Transfemoral Amputation
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Amputation of Lower Limb Above Knee, Amputee
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TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
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Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
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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.
Michael Davidson, Ph.D. principal investigator
Loma Linda University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Transfemoral Amputation, run by Loma Linda University 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Davidson, Ph.D. (9095586516, mdavidson@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 uptake - level ground (time frame: Change between Baseline Visit (study enrollment) and Visit 2 (3 weeks post-study enrollment)). 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 4 Feb 2026.