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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different prosthetic suspension systems affect movement in people with lower limb amputations. The goal is to determine if elevated vacuum suspension reduces unwanted limb movement inside the prosthetic socket, which can cause pain and skin issues. Researchers will use a special imaging technique to measure these movements. Ideal participants have had a single lower leg amputation for at least six months and currently use a prosthetic for at least six hours a day. As an unphased trial, this study allows participants to contribute to important research that could enhance prosthetic comfort and function.

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 prior data suggests that these prosthetic suspension systems are safe for individuals with lower limb amputation?

Research shows that the elevated vacuum suspension system is generally safe. Studies have found that it can enhance comfort and improve balance for prosthetic users. This system manages limb size changes after activities, leading to a better prosthetic fit and feel.

While detailed safety data for suction suspension systems is less abundant, they are widely used and well-understood. These systems secure the prosthetic with a seal, preventing excessive movement and related issues.

Both systems aim to enhance comfort and stability in prosthetic use, reducing skin problems and pain. Despite the limited detailed safety data for suction systems, their widespread use suggests they are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these prosthetic suspension systems for lower limb amputation because they offer new approaches to improving prosthetic fit and comfort. Unlike traditional suspension methods, elevated vacuum suspension systems create a more secure fit by actively removing air between the socket and the residual limb, which can enhance stability and reduce limb movement within the socket. On the other hand, suction suspension systems rely on passive suction to keep the prosthetic in place, which is simpler but may not provide the same level of control. By comparing these two methods in dynamic activities, researchers hope to identify which system offers superior comfort and function, potentially leading to better quality of life for amputees.

What evidence suggests that these prosthetic suspension systems are effective for improving limb stability?

Research has shown that elevated vacuum suspension systems, one of the systems tested in this trial, can greatly benefit people with lower leg amputations. Studies indicate that this system improves comfort, balance, and the fit of the artificial limb. It can also make walking smoother and help maintain consistent limb size. In this trial, participants will also use the suction suspension system, which has shown mixed results in managing limb size and fit. Both systems aim to reduce unwanted movement between the limb and socket, which can cause skin problems and pain. ^{1 2 6 7 8}

Who Is on the Research Team?

Jason Maikos, PhD

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Are You a Good Fit for This Trial?

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.

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

It has been over 6 months since my amputation.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK558325/

Elevated Vacuum Suspension Systems for Adults with ... - NCBI The objective of the current report is to evaluate the clinical effectiveness and cost-effectiveness of prosthetics with elevated vacuum suspension systems.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0268003316300948

The evidence-base for elevated vacuum in lower limb ... Elevated vacuum can improve proprioception, comfort, gait symmetry, circulation, prosthetic use, and amputee quality of life.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7443051/

Effectiveness of Elevated Vacuum and Suction Prosthetic ... However, higher vacuum pressures have been shown to reduce limb-socket displacement during ambulation. Even if intermediate or low vacuum pressures benefit ...

4. cda-amc.ca cda-amc.ca/elevated-vacuum-suspension-systems-adults-amputation-review-clinical-effectiveness-cost

Elevated Vacuum Suspension Systems for Adults ... The guideline also recommends that vacuum suspension systems may decrease daily limb volume fluctuations and facilitate favourable pressure ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/0309364620909044

Effectiveness of elevated vacuum and suction prosthetic ... Elevated vacuum may be more effective as a volume management strategy after accumulation of activity. Individual variation suggests the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00117793

Vacuum Suspension: Effects on Tissue Oxygenation ... The fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/0309364620909044

Effectiveness of elevated vacuum and suction prosthetic ... Elevated vacuum may be more effective as a volume management strategy after accumulation of activity.

8. withpower.com withpower.com/trial/prosthetic-suspension-systems-for-lower-limb-amputation-62046

Prosthetic Suspension Systems for Lower Limb Amputation 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 ...