Adjustable Prosthetic Sockets

Conditions

• Lower Extremity Amputation

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Adjustable prosthetic socket — DEVICE
  The investigators will fabricate and assemble an adjustable prosthetic socket for each participant whose shape is a duplicate of their existing, as-prescribed prosthetic socket. We will add three adjustable panels to the prosthetic socket which will be located over the medial and lateral proximal tibia region and the posterior gastrocnemius region. The position of the panels will be adjustable in and out using a cable mechanism.

Study Details

Each year, around 1500 Veterans join the 623,000 Americans who live with a lower limb amputation. Many of these Veterans choose the arduous path of rehabilitation to remain ambulatory, a process that includes the prescription of a lower limb prosthesis. Much relies on the goodness of fit of their prosthesis. A good fit feels comfortable and enables a variety of ambulatory activities. A poor fit results in discomfort, often accompanied by chronic skin issues, and activities of daily living are curtailed. Conventional prosthetic sockets are custom-built by a skilled prosthetist, carefully formed to fit the Veteran's residual limb, and good fits can usually be obtained. These sockets are rigid, fixed shape structures with the robustness of a bulldozer, built for sustained, heavy-duty action. Unfortunately, the shape of an individual's residual limb can change over time, such that a good fit eventually becomes poor. One estimate suggests a new below-knee socket is needed every three and a half years. The expense of replacing sockets that no longer fit is not insignificant. Medicare expenditures for replacement of existing below-knee sockets and associated components were estimated at $50M in 2017. Importantly, Medicare is estimated to be only 20% of the market, suggesting the estimated expenditure for the entire population with lower limb amputations is likely to be meaningfully larger. A good fitting prosthesis that maintains its fit over time would serve Veterans well. A potential solution that could make a good fit last longer is an adjustable prosthetic socket. While little evidence is available to support prescription practice, the Centers for Medicare and Medicaid Services (CMS) recently authorized reimbursement for adjustable prosthetic sockets, suggesting a compelling need for such a product. To investigate the potential for deleterious effects and how Veterans might use adjustable prosthetic sockets, the aim of this research is to determine the pressure applied to the residual limb by an adjustable prosthetic socket during activities of varying intensity and the activities that induce adjustments. A laboratory-based human subject experiment will be conducted using a custom sensor placed inside the adjustable panel of a study-provided adjustable prosthetic socket. Participants will acclimate to the adjustable prosthetic socket for two weeks in the field, then return to the laboratory to perform seven activities. The pressure inside the prosthesis will be measured during these activities. Participants will also report how tight their socket feels after each activity.

Key Dates

Start date

Jun 15, 2026

Status verified

Feb 2026

Primary completion

Jan 15, 2029

Completion

Aug 1, 2029

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Adjustable prosthetic socket
  Participants will wear an adjustable prosthetic socket.

Primary Outcome Measure

Distal end pressure while seated (5 min bout) [ Time Frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments ]

Central Contacts

• Elise B Campbell, MS BFA BA
  (206) 277-6792
  [email protected]

Locations (1)

Find similar trials in Seattle, WA

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