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New treatment option for Amputation
Official title A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception
ClinicalTrials.gov ID: NCT03882073
What this study is testing
- What it's testing
- The hypothesis of this research protocol is that the investigators will be able to redesign the manner in which upper limb amputations are performed so as to enable volitional control of next generation prosthetic devices and restore sensation and proprioception to the amputated limb. The investigators will test this hypothesis by performing modified above elbow or below elbow amputations in ten intervention patients, and compare their outcomes to ten control patients who have undergone tradition amputations at similar levels.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Must demonstrate sufficiently sound health to undergo the operative procedure, including adequate cardiopulmonary stability to undergo general...
- Must have intact inherent wound healing capacity
- Must demonstrate adequate communication skills to convey the status of their sensorimotor recovery throughout the postoperative phase,
You likely can't join if
- 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...
- 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...
- Patients with extensive peripheral neuropathies (diabetic or otherwise) that would potentially inhibit appropriate reinnervation of the surgical...
See the full eligibility 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- Cambridge, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States; Boston, Massachusetts, United States; Cambridge, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.