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This is a single-center, prospective, within-subject study. This study seeks to enroll a total of 32 prospective subjects who will undergo surgical implantation of the FDA-approved AltiusĀ® system. Subjects will be followed longitudinally and will complete a series of patient-reported outcome measure questionnaires, a study intake questionnaire which assesses demographics, amputation and prosthesis history, and medical/medication history.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Lower Extremity (LE) Amputees | Experimental | Adult LE amputees with chronic/intractable pain despite previous TMR and/or RPNI surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical Implantation | Device | The Altius system will be surgically implanted into the patient on one occasion. The Altius system is then used on an 'as needed' basis by patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hours Per Day of Prosthesis Use | Participants provide their average hours per day of prosthesis use over the past 7 days. | Baseline, Month 1, Month 3, Month 6 |
| Change in Days Per Week of Prosthesis Use | Participants provide their average number of days of prosthesis use over the past 7 days. | Baseline, Month 1, Month 3, Month 6 |
| Change in Prosthesis Function Level | Participants rate their current level of function with their prosthesis on a scale from 1 (extremely low) to 10 (extremely high). | Baseline, Month 1, Month 3, Month 6 |
| Change in Prosthesis Satisfaction Level | Participants rate their current level of satisfaction with their prosthesis on a scale from 1 (extremely dissatisfied) to 10 (extremely satisfied). | Baseline, Month 1, Month 3, Month 6 |
| Change in Locomotor Capabilities Index (LCI-5) Score | 14-item assessment of locomotor capabilities; each item is rated on a 5-point scale from 0 to 4; the total score is the sum of responses and ranges from 0-56; higher scores indicate greater locomotor capabilities. | Baseline, Month 1, Month 3, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Health Questionnaire-9 (PHQ-9) Score | 9-item assessment of depressive symptoms; each item is rated on a scale from 0-3; the total score is the sum of responses and ranges from 0-27; higher scores indicate greater severity of depressive symptoms. | Baseline, Month 1, Month 3, Month 6 |
| Change in Visual Analogue Score (VAS) - Residual Pain |
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Inclusion Criteria:
Exclusion Criteria:
Non-LE amputees
LE amputees without moderate to significant pain
LE amputees who have not undergone TMR, RPNI, or similar nerve targeted surgeries, amputees who have undergone these surgeries less than 9 months prior to enrollment, or amputees who have undergone these surgeries and do not have persistent pain
Patients with contraindications to implant surgery
Unable to participate in follow-ups according to study schedule (1 month, 3 months, and 6 months post-op)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacques Hacquebord, MD | Contact | 646-413-9861 | Jacques.Hacquebord@nyulangone.org | |
| Anne Genzelev | Contact | 617-835-8018 | Anne.genzelev@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Jacques Hacquebord, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
Residual pain will be rated on a VAS scale ranging from 0 (no pain) to 10 (worst possible pain). |
| Baseline, Month 1, Month 3, Month 6 |
| Change in Visual Analogue Score (VAS) - Phantom Pain | Phantom pain will be rated on a VAS scale ranging from 0 (no pain) to 10 (worst possible pain). | Baseline, Month 1, Month 3, Month 6 |
| Change in PROMIS Pain Intensity Short Form 8a Score | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 8a is an 8-item assessment of pain interference in daily life. Each item is rated on a scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses; the raw score is converted to a standardized score ranging from 0-100 with a mean of 50; higher scores indicate more pain interference. | Baseline, Month 1, Month 3, Month 6 |
| Number of Participants Taking Opioids/Narcotics for Pain | Baseline, Month 1, Month 3, Month 6 |
| Number of Participants Taking Medication for Nerve Pain | Baseline, Month 1, Month 3, Month 6 |
| Number of Participants Taking Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Pain | Baseline, Month 1, Month 3, Month 6 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |