WithdrawnEarly Phase 1

EFS Functional Expectations of Transhumeral Percutaneous OI Patients

Stopped: End of funding and device in further development

United States0Started 2024-01-01

Plain-language summary

An FDA Early Feasibility Study (EFS) allows for early clinical evaluation of devices to provide proof of principle and initial clinical safety data. The Primary Aim of this proposal is to perform an FDA guided EFS of a percutaneous osseointegrated (OI) docking system for patients with transhumeral (above elbow) amputations, establishing its initial safety. Success of the Primary Aim (Safety) will be determined over a one year follow-up period by observing the rate of patients successfully using their device without removal. The Secondary Aim of this proposal is to quantify the functional effectiveness of the OI device, giving specific attention to protocol differences required for male and female patients. Success for the Secondary Aim (Functional Effectiveness) will be to determine functional improvement with the device compared to the pre-operative performance. This will be the first longitudinal analyses to evaluate the percutaneous OI devices on objective functionality measures of transhumeral amputation individuals.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: A subject will be included in the study if he/she meets all of the following criteria: * Has a unilateral or bilateral transhumeral amputation and is at least 18 years of age * Has previously used, or is currently using, a prosthesis with a socket-based system * Is willing, able, and committed to participate in all evaluations for the study * Can provide IRB approved written informed consent to participate * Is willing to travel to Salt Lake City, Utah for a 3-day study funded visit Exclusion Criteria: A subject will be excluded from the study if he/she meets any of these criteria: * Is pregnant at the time of visit (Excluded due to radiation exposure from CT/DEXA/Xray) * Is currently receiving renal dialysis * Has muscular, neurologic, or vascular deficiencies that affect the bone or soft tissue of an affected extremity(ies) * Has, in the consensus of the investigators, physical limitations or other medical conditions that may prevent the subject from being an appropriate study candidate, i.e.: * other disease processes * mental incapacity * substance abuse (masking pain) * vulnerable subject population) * Has cardiac or pulmonary condition limiting functional abilities * Subject is a prisoner

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Device rate of safety

Timeframe: 1 year

Trial details

NCT IDNCT03824444

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2024-01-23

View on ClinicalTrials.gov More Transhumeral Amputation trials