AmputationNCT04063592
AMI Construction in Lower Extremity Residual Limbs
A study testing Residual limb revision in people with Amputation, run by Brigham and Women's Hospital at 3 sites in United States.
Trial summary
This study will involve the development of a novel approach to lower extremity residual limb surgical revision that offers the promise of augmenting volitional motor control, restore proprioception and reverse atrophy Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Residual limb revision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Feb 2020to 30 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18-65
- Has already undergone a standard AKA or BKA procedure
- Suffers from symptoms such as:
- Intractable pain
- Deterioration of skin on or around stump
- Suffering from other sources of discomfort arising from stump
Show all 9Show fewer
- Intact inherent wound healing
- Adequate communication skills
- High motivation
Who cannot join
- Inadequate health to undergo operative procedure using standard anesthesia (i.e. cardiopulmonary)
- Individuals with impaired wound healing
- Individuals suffering from extensive peripheral neuropathies
- Active smokers
- Individuals with a history of poor compliance
- Women who are pregnant or plan to become pregnant before surgical intervention
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Research Coordinators contact
United States3 sites, 3 recruiting
- Not yet recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Kyle Potter, MD, benjamin.k.potter.mil@mail.mil
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Matthew J Carty, MD, 617-983-4555, mcarty@partners.org
- Recruiting
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
Hugh Herr, PhD, 617-314-3661, hherr@media.mit.edu
About this study
Official title: A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy
This study will involve the development of a novel approach to lower extremity residual limb surgical revision that offers the promise of augmenting volitional motor control, restore proprioception and reverse atrophy
Read the detailed description
The hypothesis of this research protocol is that we will be able to modify the residual limbs of patients who have already undergone lower extremity amputations so as to include biological actuators that will enable the successful employment of next generation lower extremity prostheses, diminish/eliminate phantom limb pain, restore proprioception and regenerate lost muscle mass. The specific aims of the project are as follows:
- To develop a standardized operative technique for both above knee (AK) and below knee (BK) amputation revision procedures that includes AMIs to restore musculotendinous proprioceptive capabilities
- To assess the capacity for these actuators to provide enhanced motor control and sensory feedback, as well as ablate phantom limb symptomatology and augment residual limb muscle mass
- To determine the reinnervation time course and longevity of these biological constructs
- To validate the functional and somatosensory superiority of the proposed revision technique over standard approaches to BKA and AKA
- To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach
- Conditions
- Amputation
- Being tested
- Residual limb revision
- Keywords
- Amputation, Residual limb pain, Phantom pain, Residual limb atrophy, Prosthesis control
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Residual limb revisionProcedure or surgery
Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures Receives: Procedure: Residual limb revision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb Morphology and Changes in Muscle Volume
Clinical examination and images from CT/MRI will be combined to construct a holistic view of the morphology of the residual limb. Imaging studies and limb measurements taken in clinic will also be used to measure muscle atrophy/hypertrophy over time.
Measured: Years 1-3
Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb
Clinical examination will confirm the sliding motion of the AMI constructs with radiologic evaluation measuring the length of muscle excursion through each construct. Functional testing and testing using a prosthesis will determine how well a patient is able to volitionally control the AMI muscles.
Measured: Years 1-3
Evidence of Proprioception
Subjective reporting combined with tests run using a prosthesis will indicate if proprioception is still intact after surgery. Results will be confirmed by monitoring brain activity during limb movement activities via fMRI.
Measured: Years 1-3
Evidence of Sensory Perception
Subjective reporting and clinical tests of Semmes-Weinstein and two-point discrimination will determine if the patient has sensory perception on the residual limb.
Measured: Years 1-3
General Health
Patient-reported outcomes metrics from five validated tests (SIP136, EQ-5D, SF-36, LEFS, PROMIS) will be combined to create an overall picture of patients' general health during and after their recovery.
Measured: Years 1-3
Complications
Delayed wound healing, infection, need for additional surgery, PE/DVT, death
Measured: Years 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start24 Feb 2020
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
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 Brigham and Women's HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective clinical trial in which intervention subjects will serve as their own control
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Matthew Carty, Brigham and Women's Hospital
- Investigators
- Matthew J Carty, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063592
- Sponsor's protocol ID
- 2019P001681
- Other IDs
- CDMRP-180114
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2019
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy
- ClinicalTrials.gov ID
- NCT04063592
- Acronym / sponsor ID
- 2019P001681
- Conditions
- Amputation
- Keywords
- Amputation, Residual limb pain, Phantom pain, Residual limb atrophy, Prosthesis control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Aug 2019 (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.
This study will involve the development of a novel approach to lower extremity residual limb surgical revision that offers the promise of augmenting volitional motor control, restore proprioception and reverse atrophy
Detailed description
The hypothesis of this research protocol is that we will be able to modify the residual limbs of patients who have already undergone lower extremity amputations so as to include biological actuators that will enable the successful employment of next generation lower extremity prostheses, diminish/eliminate phantom limb pain, restore proprioception and regenerate lost muscle mass. The specific aims of the project are as follows:
- To develop a standardized operative technique for both above knee (AK) and below knee (BK) amputation revision procedures that includes AMIs to restore musculotendinous proprioceptive capabilities
- To assess the capacity for these actuators to provide enhanced motor control and sensory feedback, as well as ablate phantom limb symptomatology and augment residual limb muscle mass
- To determine the reinnervation time course and longevity of these biological constructs
- To validate the functional and somatosensory superiority of the proposed revision technique over standard approaches to BKA and AKA
- To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective clinical trial in which intervention subjects will serve as their own control
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Residual limb revisionSubjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between the ages of 18-65
- Has already undergone a standard AKA or BKA procedure
- Suffers from symptoms such as:
- Intact inherent wound healing
- Adequate communication skills
Key exclusion criteria (6 listed)
- Inadequate health to undergo operative procedure using standard anesthesia (i.e. cardiopulmonary)
- Individuals with impaired wound healing
- Individuals suffering from extensive peripheral neuropathies
- Active smokers
- Individuals with a history of poor compliance
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 |
|---|---|---|
| Residual limb revisionSurgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs) | Procedure or surgery | Intervention |
Primary outcome
Limb Morphology and Changes in Muscle Volume
Time frame: Years 1-3
Clinical examination and images from CT/MRI will be combined to construct a holistic view of the morphology of the residual limb. Imaging studies and limb measurements taken in clinic will also be used to measure muscle atrophy/hypertrophy over time.
Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb
Time frame: Years 1-3
Clinical examination will confirm the sliding motion of the AMI constructs with radiologic evaluation measuring the length of muscle excursion through each construct. Functional testing and testing using a prosthesis will determine how well a patient is able to volitionally control the AMI muscles.
Evidence of Proprioception
Time frame: Years 1-3
Subjective reporting combined with tests run using a prosthesis will indicate if proprioception is still intact after surgery. Results will be confirmed by monitoring brain activity during limb movement activities via fMRI.
Evidence of Sensory Perception
Time frame: Years 1-3
Subjective reporting and clinical tests of Semmes-Weinstein and two-point discrimination will determine if the patient has sensory perception on the residual limb.
General Health
Time frame: Years 1-3
Patient-reported outcomes metrics from five validated tests (SIP136, EQ-5D, SF-36, LEFS, PROMIS) will be combined to create an overall picture of patients' general health during and after their recovery.
Complications
Time frame: Years 1-3
Delayed wound healing, infection, need for additional surgery, PE/DVT, death
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 9 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers
Related trials for Amputation
Active, not recruiting
Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees
Amputation
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Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
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Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
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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.
Research Coordinators contact
Matthew J Carty, MD principal investigator
Brigham and Women's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Residual limb revision in people with Amputation, run by Brigham and Women's Hospital at 3 sites 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 9 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Matthew J Carty, MD (6179834555, mcarty@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb Morphology and Changes in Muscle Volume (time frame: Years 1-3). 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 9 Jul 2026.