Innovative surgery for improving lower limb prosthetics and reducing pain in amputees
A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy
NA · Brigham and Women's Hospital · NCT04063592
This study is testing a new type of surgery for amputees to see if it can help reduce pain and improve movement by using special devices in their residual limb.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital (other) |
| Locations | 3 sites (Bethesda, Maryland and 2 other locations) |
| Trial ID | NCT04063592 on ClinicalTrials.gov |
What this trial studies
This study focuses on a novel surgical revision technique for patients with lower extremity amputations, aiming to enhance motor control and sensory feedback through the incorporation of biological actuators in the residual limb. The research will evaluate the effectiveness of this approach in alleviating phantom limb pain, restoring proprioception, and regenerating muscle mass. Specific aims include developing a standardized surgical technique, assessing the functionality of the actuators, and creating a tailored rehabilitation strategy for post-operative care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 who have undergone above or below knee amputation and experience significant pain or discomfort from their residual limb.
Not a fit: Patients who are not in good health to undergo surgery, have impaired wound healing, or suffer from extensive peripheral neuropathies 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 reducing pain and enhancing the functionality of prosthetic limbs.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in enhancing prosthetic control and reducing phantom pain, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Intact inherent wound healing * Adequate communication skills * High motivation Exclusion Criteria: * 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
Where this trial is running
Bethesda, Maryland and 2 other locations
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (NOT_YET_RECRUITING)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
- Massachusetts Institute of Technology — 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.
Conditions: Amputation, Residual limb pain, Phantom pain, Residual limb atrophy, Prosthesis control