PODS for Transhumeral Amputation

1
Effectiveness
1
Safety
VA Salt Lake City Health Care System, Salt Lake City, UT, Salt Lake City, UT
PODS - Device
Eligibility
18+
All Sexes
Eligible conditions
Transhumeral Amputation

Study Summary

This study is evaluating whether a new type of prosthetic may be more effective than current prosthetics.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether PODS will improve 1 primary outcome and 1 secondary outcome in patients with Transhumeral Amputation. Measurement will happen over the course of 1 year.

1 year
Device rate of safety
Effectivenss of device to increase in function

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
Treatment

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. PODS is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Treatment
Device
Implant and followup
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

VA Salt Lake City Health Care System, Salt Lake City, UT - Salt Lake City, UT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Is willing to travel to Salt Lake City, Utah for a 3-day funded visit. show original
The person has had an amputation through the shoulder joint, either on one side or both sides, and is over 18 years old. show original
Previously used a prosthesis with a socket-based system, or is currently using one. show original
I willing to participate in all evaluations for the study show original
In order to participate in this study, you must be able to provide written informed consent that has been approved by an IRB. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of transhumeral amputation?

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The most common symptoms of thalamic thrombosis are headache and focal deficits such as contralateral hemiparesis, neglect and agnosia. The ipsilateral hemiparesis and neglect may be a transient phenomenon. The risk of thalamic infarction following thalamic thrombosis is approximately 50%. Transhumeral amputation is always necessary for ischemic limb. This is an unusual and severe complication of thalamic thrombosis that requires immediate surgical intervention.

Unverified Answer

Can transhumeral amputation be cured?

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This case demonstrates the need for ongoing education and training for clinicians involved in the treatment and rehabilitation of patients with complex transhumeral amputation defects. Given our limited experience with this defect we recommend a clinical trial be considered at the first attempt, and the patient should be monitored for any change in wound infection or complications, as long as the need exists.

Unverified Answer

What is transhumeral amputation?

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It is an important consideration to consider in amputees who present with chronic pain related to a failed transhumeral amputation especially in cases where the reason for failing an amputation is an unifascicular deficit.

Unverified Answer

How many people get transhumeral amputation a year in the United States?

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About 5.4 million children in the United States have surgery for transhumeral amputation. There is great variance across states for rates of amputation for children with congenital heart diseases. The need for a research strategy is discussed.

Unverified Answer

What causes transhumeral amputation?

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Transhumeral amputation as a surgical procedure is a rare but well-differentiated, single entity. A multifactorial aetiological strategy involving a combination of intraoperative and postoperative surgical, medical, procedural, and environmental factors is not uncommon and may lead to a delay in initiating appropriate treatment. We also observed that the aetiology of PH amputation appears to have a high incidence of polyneuropathy with axonal involvement and is often accompanied by neuropathy. Therefore, a multifactorial aetiological strategy may be more appropriate in PH amputation.

Unverified Answer

What are common treatments for transhumeral amputation?

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Although many different amputations can now be avoided, the THA remains an important treatment for individuals with certain disabling peripheral conditions. Even those who undergo an amputation will typically have more than one type of surgery.

Unverified Answer

Has pods proven to be more effective than a placebo?

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Findings from a recent study of this study suggest that the use of a gel formulation of a PAD may be an effective and inexpensive intervention for reducing discomfort in patients undergoing lower extremity transhumeral amputation.

Unverified Answer

What is the primary cause of transhumeral amputation?

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Given the complexity and variety of possible etiologies and associations of transhumeral amputations, it appears that both medical and aetiologic theories must be considered in evaluating transhumeral amputations.

Unverified Answer

What are the latest developments in pods for therapeutic use?

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The treatment possibilities from the use of transosseous stimulation devices are growing and there are many new innovations to use in the treatment of injuries in general and more specifically to treat trauma or pathologic conditions and to increase or decrease exercise regimes to ensure proper loading to minimize or maximize bone healing; in particular, a transosseous stimulation device is a device worn over the top of the bone to help increase bone strength and quality.

Unverified Answer

Have there been any new discoveries for treating transhumeral amputation?

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Many new techniques and procedures to help treat transhumeral amputation have yet to be implemented on a large scale. Nonetheless, the majority of the research reported in the last decade has created much progress within the field of amputation revascularization. The majority of the advancement in the field has been made by the use of microsurgical vascular anastomosis. It was found that these microsurgical advances do not work if grafts were used with standard anastomotic materials, and many surgeons still rely on conventional means to accomplish healing of amputations. One of the most prevalent techniques is the use of free flaps to treat amputees.

Unverified Answer

Who should consider clinical trials for transhumeral amputation?

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Clinical trials can help patients who meet their treatment goals by providing a new option like a transhumeral amputation. An important part of the decision-making process is the risks and benefits of that procedure. Clinical trials can help us to identify the best surgical management and the people who should be considered in these trials before the amputation. For patients, clinical trials can help providers to develop an expectation of outcomes and tailor a treatment plan to the needs of patients.

Unverified Answer

What is the average age someone gets transhumeral amputation?

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Transhumeral amputation is recommended for people who have a life expectancy less than 25 years and people who have disabling lower extremity complications. The age of the person with transhumeral amputation should be considered when evaluating their risks.

Unverified Answer
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