Prosthetic Suspension Systems for Lower Limb Amputation

Recruiting at 1 trial location

Overseen By Michael J Hyre, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Severe neuropathy, uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

21 Participants Needed

Trial Summary

What is the purpose of this trial?

Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning. Pistoning can lead to gait instability, skin problems, and pain. Different prosthetic suspension systems have been developed to decrease this motion, including elevated vacuum suspension, which utilizes a pump to draw air from the socket. However, scientific analyses to understand the movement between the limb and socket have yet to be performed with a high level of accuracy. This study will use a state-of-the art imaging technique, known as dynamic stereo x-ray, to quantify the 3D movement of the residual limb in the socket. It is hypothesized that dynamic stereo x-ray will be a sensitive method to measure differences in residual limb movement between 2 different socket suspension techniques: suction and elevated vacuum suspension. This information is critical for advancing prosthetic treatments to reduce secondary conditions and degenerative changes that result from poor prosthetic fit.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Elevated Vacuum Suspension for lower limb amputation?

Research shows that vacuum-assisted suspension systems can improve the fit and comfort of prosthetic limbs, potentially enhancing the quality of life for people with lower limb amputations. They may also help manage residual limb wounds by reducing movement within the prosthetic socket, which can be beneficial for healing. ^{1 2 3 4 5}

Is the elevated vacuum suspension system safe for humans?

The elevated vacuum suspension system is generally considered safe for humans, as studies have shown it can improve comfort and step length symmetry for people with lower limb amputations, with no significant safety concerns reported. ^{1 2 3 4 6}

How is the Elevated Vacuum Suspension System treatment different from other treatments for lower limb amputation?

The Elevated Vacuum Suspension System is unique because it uses vacuum pressure to create a secure fit between the prosthetic and the limb, which can improve comfort and potentially enhance physical activity and quality of life compared to non-vacuum systems. ^{1 2 3 4 7}

Research Team

Jason Maikos, PhD

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Eligibility Criteria

This trial is for adults over 18 with a below-the-knee amputation who have been using a prosthetic limb for at least six months. It's not suitable for those with severe skin conditions, neuropathy, uncontrolled diabetes, mental impairments that affect compliance, or women who are pregnant or planning pregnancy during the study.

Inclusion Criteria

I have had one of my lower legs amputated below the knee.

It has been over 6 months since my amputation.

I use a prosthetic for at least 6 hours every day.

Exclusion Criteria

You cannot wear the socket suspensions comfortably.

You have a mental condition that makes it difficult for you to follow the study requirements.

I am not pregnant and do not plan to become pregnant during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acclimation

Participants undergo a 4-week acclimation period with the prosthetic socket

4 weeks

Testing

Dynamic stereo x-ray is used to track skeletal and skin/liner motion under both suspension techniques during dynamic activities

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

Treatment Details

Interventions

• Elevated Vacuum Suspension First
• Suction Suspension First

Trial Overview The study aims to measure how much the remaining lower leg moves inside two types of prosthetic sockets using dynamic stereo x-ray imaging. Participants will try both suction suspension and elevated vacuum suspension systems to see which reduces limb movement better.

Participant Groups

Group I: Suction Suspension First Active Control 1 Intervention

The residual limb will be imaged during dynamic activities while participants use suction suspension first, then while participants use elevated vacuum suspension. Dynamic stereo x-ray will take place 4-weeks after socket fitting.

Group II: Elevated Vacuum Suspension First Active Control 1 Intervention

The residual limb will be imaged during dynamic activities while participants use elevated vacuum suspension first, then while participants use suction suspension. Dynamic stereo x-ray will take place 4-weeks after socket fitting.

Elevated Vacuum Suspension First is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Elevated Vacuum Suspension for:

• Transtibial amputation
• Lower extremity amputation

Approved in European Union as Elevated Vacuum Suspension for:

• Transtibial amputation
• Lower extremity amputation

Approved in Canada as Elevated Vacuum Suspension for:

• Transtibial amputation
• Lower extremity amputation

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

University of Rhode Island

Collaborator

Trials

57

Recruited

22,400+

Findings from Research

In a study involving 20 unilateral transtibial amputees, the vacuum-assisted socket suspension system (VASS) resulted in significantly less residual limb pistoning compared to the pin suspension system, indicating a better fit in terms of socket stability.

However, participants were less active and preferred the pin suspension system, taking about half as many steps while using the VASS, suggesting that while VASS may improve fit, it may not enhance overall mobility or user satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum-assisted socket suspension compared with pin suspension for lower extremity amputees: effect on fit, activity, and limb volume. Klute, GK., Berge, JS., Biggs, W., et al.[2015]

A review of 26 studies involving an average of 7 transtibial and 6 transfemoral amputees suggests that elevated vacuum suspension systems may enhance comfort and quality of life for individuals with limb loss.

While these vacuum systems show potential benefits over traditional suspension methods, they may not be suitable for everyone, highlighting the need for further research with larger sample sizes to assess long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evidence-base for elevated vacuum in lower limb prosthetics: Literature review and professional feedback. Gholizadeh, H., Lemaire, ED., Eshraghi, A.[2018]

In a study involving 9 unilateral transtibial amputees, higher vacuum levels (15 and 20 inHg) improved comfort and provided some relief to the intact limb, but also increased the risk of osteoarthritis in the residual limb due to higher peak hip and knee moments.

Very low vacuum levels negatively impacted gait symmetry, suggesting that a moderate vacuum level of 15 inHg is optimal for maintaining balance and reducing the risk of joint issues in amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum level effects on gait characteristics for unilateral transtibial amputees with elevated vacuum suspension. Xu, H., Greenland, K., Bloswick, D., et al.[2018]

A study involving 51 individuals with transtibial amputation and 51 able-bodied controls found that both vacuum-assisted and PIN/LOCK suspension systems did not significantly improve physical activity levels or quality of life compared to each other.

Participants with amputation reported lower physical activity and quality of life scores than able-bodied controls, and vacuum-assisted system users experienced more bodily pain, indicating that neither suspension system provided a clear advantage in enhancing user well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reported physical activity and quality of life in people with lower limb amputation using two types of prosthetic suspension systems. Çalışkan Uçkun, A., Yurdakul, FG., Almaz, ŞE., et al.[2022]

In a case series involving six subjects with transtibial amputation, the use of vacuum-assisted suspension sockets allowed for continued prosthetic use while healing residual limb wounds, with an average wound closure time of 177.6 days.

The initial average wound size was 2.17 cm², and the findings indicate that these well-fitting sockets did not hinder the healing process, suggesting a potential new approach to managing residual limb wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using vacuum-assisted suspension to manage residual limb wounds in persons with transtibial amputation: a case series. Hoskins, RD., Sutton, EE., Kinor, D., et al.[2022]

The Unity elevated vacuum suspension system showed a small but notable improvement in step length symmetry between intact and prosthetic limbs during level walking when the vacuum was active, suggesting a potential benefit for gait performance.

Overall, while some gait parameters showed differences between the vacuum ON and OFF conditions, these differences were minimal and may not be clinically significant, indicating that a well-fitting liner-based socket is crucial for optimal performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transtibial amputee gait with the unity suspension system. Gholizadeh, H., Lemaire, ED., Sinitski, EH., et al.[2020]

In a study involving 12 unilateral transtibial amputees, the new magnetic suspension system showed significantly lower peak pressure in the prosthetic socket compared to the pin/lock system, which may lead to reduced discomfort during walking.

The magnetic system also resulted in lower average peak pressure than the Seal-In system, suggesting it could be a more comfortable option for amputees by minimizing pressure on the residual limb.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An experimental study of the interface pressure profile during level walking of a new suspension system for lower limb amputees. Eshraghi, A., Abu Osman, NA., Gholizadeh, H., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Vacuum-assisted socket suspension compared with pin suspension for lower extremity amputees: effect on fit, activity, and limb volume. [2015]

2. England pubmed.ncbi.nlm.nih.gov

The evidence-base for elevated vacuum in lower limb prosthetics: Literature review and professional feedback. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Vacuum level effects on gait characteristics for unilateral transtibial amputees with elevated vacuum suspension. [2018]

4. France pubmed.ncbi.nlm.nih.gov

Reported physical activity and quality of life in people with lower limb amputation using two types of prosthetic suspension systems. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Using vacuum-assisted suspension to manage residual limb wounds in persons with transtibial amputation: a case series. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Transtibial amputee gait with the unity suspension system. [2020]

7. England pubmed.ncbi.nlm.nih.gov

An experimental study of the interface pressure profile during level walking of a new suspension system for lower limb amputees. [2019]