Transfemoral AmputationNCT07615465
An Osseointegrated Transfemoral Prosthesis Offering Long-Term Bi-Directional Efferent-Afferent Neural Transmission
A study testing MIT Powered Knee Prosthesis in people with Transfemoral Amputation, run by Massachusetts Institute of Technology at 1 site in United States.
Trial summary
The purpose of the study is to investigate the clinical and functional outcomes of a transfemoral amputation with osseointegrated titanium implant, AMI muscle constructs, and implanted electrodes in the domain of gait, free space control, and embodiment. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Transfemoral Amputation
- What is being tested?
- MIT Powered Knee Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2017to 17 Jul 2026
- Phase
- Interventional
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 Male or Female age 22-65 at the time of surgery.
- 2 The patient must have a medical condition requiring performance of a unilateral transfemoral amputation with a minimum of 13 cm of residual femur after amputation, and: A. At a minimum level of amputation of 20 cm or greater above the knee joint line if physical therapy and prosthetist evaluation is commensurate with a standard K3 ambulatory status; or, B. At a minimum level of amputation of 16 cm above the knee joint line as part of a single- stage procedure if physical therapy and prosthetist evaluation is commensurate with a more active K3 or less active K4 postoperative ambulatory status.
- The subject must have undergone independent consultation with at least two lower extremity surgical specialists to ensure they have exhausted all limb salvage options prior to undergoing amputation, as well as a psychiatric evaluation to ensure appropriate capacity and volition.
- The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).
- The patient must have adequate bone stock to support the implanted device.
- In the opinion of the investigators, normal cognitive function and absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude patient from being a good surgical and/or study candidate.
- Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study including the prescribed rehabilitation program.
- Written informed consent to participate in the study provided by the patient or legal representative.
Who cannot join
- Women who are pregnant, lactating or planning a pregnancy during the first twelve (12) months of the post-surgical follow- up.
- Subjects who have not been completely abstinent from tobacco use for at least 6 weeks preoperatively.
- Active infection or dormant bacteria.
- Subjects would have less than 2 mm of remaining cortex bone available around the implant, if implanted.
- Evidence of or a documented history of severe peripheral vascular disease, diabetes mellitus (type I or type II), skin diseases, Neuropathy or neuropathic disease and severe phantom pain, or osteoporosis, such that, in the opinion of the investigator, will not allow the subject to be a good study candidate.
- Evidence of any active skin disease involving the proposed surgical limb.
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- History of systemically administered corticosteroids, immune- suppressive therapy or chemotherapy drugs within six (6) months of implant surgery.
- Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI >40, etc.).
- The patient is currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of this clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Osseointegrated Transfemoral Prosthesis Offering Long-Term Bi-Directional Efferent-Afferent Neural Transmission - IDE Required
The purpose of the study is to investigate the clinical and functional outcomes of a transfemoral amputation with osseointegrated titanium implant, AMI muscle constructs, and implanted electrodes in the domain of gait, free space control, and embodiment.
- Conditions
- Transfemoral Amputation
- Being tested
- MIT Powered Knee Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIT Powered Knee ProsthesisDevice
MIT powered knee prosthesis developed by the MIT Biomechatronics Group.
| Study group | Role | What they receive |
|---|---|---|
| Osseointegration surgery | Experimental | Transfemoral amputation with osseointegrated titanium implant, AMI muscle constructs, and implanted electrodes Receives: Device: MIT Powered Knee Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic Measures of Lower-Limb Biomechanics
Quantitative analysis of joint angles, during level-ground walking, stair negotiation, and other functional tasks. Outcomes will be assessed using a motion capture system (e.g., Vicon) and embedded prosthesis sensors.
Measured: An average of 2 sessions in the span of 1 week
Spatiotemporal Gait Parameters
Evaluation of stance-to-swing ratio during ambulation. Parameters will be obtained using a motion capture system (e.g., Vicon) and an instrumented walkway. Data will be analyzed to assess functional walking ability and compared to normative or baseline values.
Measured: An average of 2 sessions in the span of 1 week
Assessment of Patient Ability to Control each Joint of the Prosthesis
Assessment of volitional control of the powered knee and ankle joints via neural signals from the residual limb. Participants will perform isolated joint control trials in seated positions. Outcomes include joint command accuracy evaluated using surface electromyography (EMG) and motion capture. These measures will quantify the participant's ability to intentionally control each prosthetic joint.
Measured: An average of 2 sessions in the span of 1 week
Ground Reaction Forces
Quantitative analysis of ground reaction forces during level-ground walking, stair negotiation, and other functional tasks. Outcomes will be assessed using instrumented force plates.
Measured: An average of 2 sessions in the span of 1 week
Joint Torques
Quantitative analysis of joint torques during level-ground walking, stair negotiation, and other functional tasks. Outcomes will be assessed using a motion capture system (e.g., Vicon), instrumented force plates, and embedded prosthesis sensors.
Measured: An average of 2 sessions in the span of 1 week
Walking speed
Evaluation of walking speed during ambulation. Parameters will be obtained using a motion capture system (e.g., Vicon) and an instrumented walkway. Data will be analyzed to assess functional walking ability and compared to normative or baseline values.
Measured: An average of 2 sessions in the span of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start15 Apr 2017
- Primary completion18 Jul 2025
- Study completion17 Jul 2026
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.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Integrum
- Responsible party
- Sponsor
- Investigators
- Hugh Herr, PhD, Principal investigator, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615465
- Sponsor's protocol ID
- 1703900740
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. This study involves a small cohort and a particular surgical procedure. Even with direct identifiers removed, the combination of clinical timelines and outcomes could increase the risk of re-identification. Summary/aggregate results (and selected analyses) have been reported in a peer-reviewed publication.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Osseointegrated Transfemoral Prosthesis Offering Long-Term Bi-Directional Efferent-Afferent Neural Transmission - IDE Required
- ClinicalTrials.gov ID
- NCT07615465
- Acronym / sponsor ID
- 1703900740
- Conditions
- Transfemoral Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Collaborators
- Integrum
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 17 Jul 2026 (actual)
- First posted
- 29 May 2026 (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 the study is to investigate the clinical and functional outcomes of a transfemoral amputation with osseointegrated titanium implant, AMI muscle constructs, and implanted electrodes in the domain of gait, free space control, and embodiment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osseointegration surgery | Experimental | Device: MIT Powered Knee ProsthesisTransfemoral amputation with osseointegrated titanium implant, AMI muscle constructs, and implanted electrodes |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1 Male or Female age 22-65 at the time of surgery.
- 2 The patient must have a medical condition requiring performance of a unilateral transfemoral amputation with a minimum of 13 cm of residual femur after amputation, and: A. At a minimum level of amputation of 20 cm or greater above the knee joint line if physical therapy and prosthetist evaluation is commensurate with a standard K3 ambulatory status; or, B. At a minimum level of amputation of 16 cm above the knee joint line as part of a single- stage procedure if physical therapy and prosthetist evaluation is commensurate with a more active K3 or less active K4 postoperative ambulatory status.
- The subject must have undergone independent consultation with at least two lower extremity surgical specialists to ensure they have exhausted all limb salvage options prior to undergoing amputation, as well as a psychiatric evaluation to ensure appropriate capacity and volition.
- The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).
- The patient must have adequate bone stock to support the implanted device.
Key exclusion criteria (9 listed)
- Women who are pregnant, lactating or planning a pregnancy during the first twelve (12) months of the post-surgical follow- up.
- Subjects who have not been completely abstinent from tobacco use for at least 6 weeks preoperatively.
- Active infection or dormant bacteria.
- Subjects would have less than 2 mm of remaining cortex bone available around the implant, if implanted.
- Evidence of or a documented history of severe peripheral vascular disease, diabetes mellitus (type I or type II), skin diseases, Neuropathy or neuropathic disease and severe phantom pain, or osteoporosis, such that, in the opinion of the investigator, will not allow the subject to be a good study candidate.
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 |
|---|---|---|
| MIT Powered Knee ProsthesisMIT powered knee prosthesis developed by the MIT Biomechatronics Group. | Device | Osseointegration surgery |
Primary outcome
Kinematic Measures of Lower-Limb Biomechanics
Time frame: An average of 2 sessions in the span of 1 week
Quantitative analysis of joint angles, during level-ground walking, stair negotiation, and other functional tasks. Outcomes will be assessed using a motion capture system (e.g., Vicon) and embedded prosthesis sensors.
Spatiotemporal Gait Parameters
Time frame: An average of 2 sessions in the span of 1 week
Evaluation of stance-to-swing ratio during ambulation. Parameters will be obtained using a motion capture system (e.g., Vicon) and an instrumented walkway. Data will be analyzed to assess functional walking ability and compared to normative or baseline values.
Assessment of Patient Ability to Control each Joint of the Prosthesis
Time frame: An average of 2 sessions in the span of 1 week
Assessment of volitional control of the powered knee and ankle joints via neural signals from the residual limb. Participants will perform isolated joint control trials in seated positions. Outcomes include joint command accuracy evaluated using surface electromyography (EMG) and motion capture. These measures will quantify the participant's ability to intentionally control each prosthetic joint.
Ground Reaction Forces
Time frame: An average of 2 sessions in the span of 1 week
Quantitative analysis of ground reaction forces during level-ground walking, stair negotiation, and other functional tasks. Outcomes will be assessed using instrumented force plates.
Joint Torques
Time frame: An average of 2 sessions in the span of 1 week
Quantitative analysis of joint torques during level-ground walking, stair negotiation, and other functional tasks. Outcomes will be assessed using a motion capture system (e.g., Vicon), instrumented force plates, and embedded prosthesis sensors.
Walking speed
Time frame: An average of 2 sessions in the span of 1 week
Evaluation of walking speed during ambulation. Parameters will be obtained using a motion capture system (e.g., Vicon) and an instrumented walkway. Data will be analyzed to assess functional walking ability and compared to normative or baseline values.
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 7 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. This study involves a small cohort and a particular surgical procedure. Even with direct identifiers removed, the combination of clinical timelines and outcomes could increase the risk of re-identification. Summary/aggregate results (and selected analyses) have been reported in a peer-reviewed publication.
Related trials for Transfemoral Amputation
Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Active, not recruiting
Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
Amputation, Transfemoral Amputation
Not yet recruiting
Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation
Unilateral Transfemoral Amputation in Prosthetic Users
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.
Hugh Herr, PhD principal investigator
Massachusetts Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIT Powered Knee Prosthesis in people with Transfemoral Amputation, run by Massachusetts Institute of Technology 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 9 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 7 Oct 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?
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.
What does the primary outcome measure?
Kinematic Measures of Lower-Limb Biomechanics (time frame: An average of 2 sessions in the span of 1 week). The study lists 6 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 7 Oct 2026.