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 Altius® 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
32
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.
NYU Langone Health
New York, New York, United States
Change in Hours Per Day of Prosthesis Use
Participants provide their average hours per day of prosthesis use over the past 7 days.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline, Month 1, Month 3, Month 6
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.
Time frame: Baseline, Month 1, Month 3, Month 6
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Change in Visual Analogue Score (VAS) - Residual Pain
Residual pain will be rated on a VAS scale ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: 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).
Time frame: 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.
Time frame: Baseline, Month 1, Month 3, Month 6
Number of Participants Taking Opioids/Narcotics for Pain
Time frame: Baseline, Month 1, Month 3, Month 6
Number of Participants Taking Medication for Nerve Pain
Time frame: Baseline, Month 1, Month 3, Month 6
Number of Participants Taking Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Pain
Time frame: Baseline, Month 1, Month 3, Month 6