Adjustable Prosthetic Socket for Below Knee Amputation

(SocketFit Trial)

Overseen By Alena Grabowski, PhD BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cardiovascular, Pulmonary, Neurological, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 years

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new prosthetic socket with adjustable panels can improve mobility for veterans with lower limb amputations compared to traditional sockets. The goal is to determine which socket style provides better comfort and function, aiding rehabilitation. The trial seeks veterans with transtibial (below-the-knee) or transfemoral (above-the-knee) amputations who can navigate small obstacles like curbs or stairs. Participants should not have current issues with their prosthesis or residual limb and must be at least six months post-amputation. As a Phase 2 trial, this research measures the effectiveness of the new socket design in an initial, smaller group, offering participants a chance to contribute to advancements in prosthetic technology.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prosthetic socket adjustment is safe for people with lower limb amputation?

Research has shown that adjustable prosthetic sockets can enhance comfort for individuals with lower leg amputations. For those with a below-the-knee amputation, one study found that these sockets improved comfort by 3.13 points and satisfaction by 4.57 points, indicating general user approval and no major safety concerns.

For individuals with above-the-knee amputations, adjustable sockets also appear promising. A study found that these prosthetics allowed for safe and comfortable walking, suggesting they are generally safe and effective for daily use.

Overall, these findings suggest that adjustable prosthetic sockets are safe and may improve users' quality of life by providing a good fit and comfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it tackles a crucial issue for veterans with transtibial and transfemoral amputations: socket fit. Unlike traditional prosthetic fittings that often lead to discomfort and limited mobility, this approach aims to optimize the fit for both male and female veterans. By focusing on personalized adjustments and considering anatomical differences, the trial could significantly improve comfort, stability, and quality of life for participants. This could potentially set a new standard in prosthetic care, offering a more tailored and effective solution.

What evidence suggests that this prosthetic socket adjustment is effective for lower limb amputation?

Research shows that adjustable prosthetic sockets for below-knee amputations can enhance comfort and fit. One study found that these sockets automatically adjust while walking, aiding daily comfort and movement. Another study used AI technology to design these sockets, showing promising results, though more research is needed to understand long-term effects. This trial will study one group of veterans with transtibial (below-knee) amputations.

For above-knee amputations, studies suggest that adjustable sockets improve comfort and fit by adapting to changes in the size of the remaining limb. In one comparison, adjustable sockets led to higher patient satisfaction and better mobility than standard ones. This trial will study another group of veterans with transfemoral (above-knee) amputations. These findings offer hope for better outcomes with adjustable sockets for both types of amputations. ^{1 3 6 7 8}

Who Is on the Research Team?

Alena Grabowski, PhD BA

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

Inclusion Criteria

You are 20 or older and have a unilateral transtibial amputation.

A maximum of 40 Veterans will be recruited.

All participants must have a fully functional prosthesis and be at least 6-months post-amputation with no current issues regarding their residual limb.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are fitted with adjustable and conventional prosthetic sockets to assess biomechanical asymmetry, socket pistoning, and comfort/satisfaction

4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prosthetic Socket Adjustment

How Is the Trial Designed?

Group I: Veterans with a transtibial amputation Experimental Treatment 2 Interventions

20 Veterans with a transtibial amputation, 10 females and 10 males

Group II: Veterans with a transfemoral amputation Experimental Treatment 2 Interventions

20 Veterans with a transfemoral amputation, 10 females and 10 males

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9712408/

Comparison of functional outcome and patient satisfaction ... In this study, transfemoral amputees treated with an osseointegrated prosthetic attachment (TOPS) showed significantly higher scores for mobility and ...

2. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01270-0

Adjustable prosthetic sockets: a systematic review of industrial ... This paper reviews adjustable socket designs, as they have the potential to improve prosthetic fit and comfort through accommodating residual limb volume ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S8756328223000856

Above knee socket prosthesis use changes proximal femur ... Patients with transfemoral amputation (TFA) are up to six times more likely to develop hip osteoarthritis (OA) in either or both the intact and residual ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5218538/

COMPARATIVE EFFECTIVENESS OF AN ADJUSTABLE ... In this case study, the SOC socket was inferior to the comparative adjustable transfemoral amputation interface in subjective and performance outcomes.

5. nature.com nature.com/articles/s41598-024-61234-9

An adaptive prosthetic socket for people with transtibial ... This study presents results from take-home testing of a motor-driven adaptive socket that automatically adjusted socket size during walking.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8994512/

Degree of Safety Against Falls Provided by 4 Different ... Fluid-controlled prosthetic knees expose inpatients with transfemoral amputation to higher incidence of falling than MPK during rehabilitation training.

7. rehab.research.va.gov rehab.research.va.gov/jour/2016/536/pdf/jrrd-2014-12-0311.pdf

The biomechanical response of persons with transfemoral ... Abstract—Prosthetic alignment is an important factor in the overall fit and performance of a lower-limb prosthesis. However,.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2590109522000246

A Prospective Assessment of an Adjustable, Immediate Fit ... The adjustable, immediate fit, subischial prosthesis provided safe, comfortable, and functional ambulation for persons with transfemoral limb loss.