A new method for upper limb amputation to improve control and sensation
A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception
This study is testing a new way to perform upper limb amputations to see if it can help patients control advanced prosthetics better and feel more sensation in their limbs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 4 sites (Bethesda, Maryland and 3 other locations) |
| Trial ID | NCT03882073 on ClinicalTrials.gov |
What this trial studies
This research aims to redesign upper limb amputation procedures to enhance volitional control of advanced prosthetic devices and restore proprioception in amputated limbs. The study will involve modified above elbow and below elbow amputations in ten patients, comparing their outcomes with ten control patients who undergo traditional amputations. The specific goals include establishing a standardized surgical approach, measuring motor activation in the residual limb, and assessing the extent of proprioceptive feedback achieved through the new technique.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who require elective unilateral or bilateral upper extremity amputation due to trauma, congenital deformities, or arthritis.
Not a fit: Patients with severe comorbidities or those who do not meet the health and communication criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for amputees by enhancing their control over prosthetic devices and restoring sensory feedback.
How similar studies have performed: While there have been advancements in prosthetic technology, this specific approach to amputation is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males or females between the ages of 18 and 65 * Candidates for elective unilateral or bilateral upper extremity amputation at either the above elbow or below elbow level due to traumatic injury, congenital limb deformities or progressive arthritis * Must demonstrate sufficiently sound health to undergo the operative procedure, including adequate cardiopulmonary stability to undergo general anesthesia (specifically, American Society of Anesthesiology Class I or II) * Must have intact inherent wound healing capacity * Must demonstrate adequate communication skills to convey the status of their sensorimotor recovery throughout the postoperative phase, * Must exhibit proper level of motivation to comply with postoperative follow up requirements * Must be willing to also consent to study activities taking place at Massachusetts Institute of Technology (approved under same IRB protocol via ceded IRB review) as some outcome measures will be assessed at that site Exclusion Criteria: * Patients beyond the stated age restrictions * Those with severe illness rendering them unable to undergo the operative procedure safely (e.g., unresolved sepsis or cardiopulmonary instability manifest as documented coronary artery disease and/or chronic obstructive pulmonary disease) * Patients with active infections, particularly deep infections in the arm to be amputated * Patients who are taking immunosuppressive agents * Patients with impairment in inherent wound healing pathways, such as those with primary connective tissue disorders or those on chronic steroid therapy * Patients with extensive peripheral neuropathies (diabetic or otherwise) that would potentially inhibit appropriate reinnervation of the surgical constructs * Active smokers; those patients willing to undergo tobacco cessation will need to be completely abstinent from tobacco use for at least 6 weeks preoperatively * Patients who are unable to provide informed consent and those with a demonstrated history of poor compliance * Pregnant women will not be considered due to the potential risks of general anesthesia Patients will not be excluded from participation in the study on the grounds of minority status, religious status, race or gender. Non-English speaking patients will not be excluded from the study; interpreters will be made available to them for translation of both verbal interactions and written documents.
Where this trial is running
Bethesda, Maryland and 3 other locations
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Recruiting)
- Brigham & Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Massachusetts Institute of Technology Media Lab — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Matthew J Carty, MD — Brigham and Women's Hospital
- Study coordinator: Matthew J Carty, MD
- Email: mcarty@partners.org
- Phone: 6179834555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.