Southern Bone & Joint Study - Brimless Sockets

University of South Florida

Status and phase: Completed; Phase 3

Conditions: Socket Designs of Transfemoral Amputees.

Treatments: Device: Prosthetic brimless socket; Device: Standard of care socket

Study type: Interventional

Funder types: Other

Identifiers

NCT01416129

6140101600

Details and patient eligibility

About

The investigators are comparing a new type of prosthetic socket for above knee amputees to the standard of care. The hypothesis is that the new type of socket will show equivalence to the standard of care using our designated outcome measures.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Unilateral transfemoral or knee-disarticulation amputee
• 18 to 85 years of age
• K3 (variable cadence and community) ambulators;
• Be able to independently provide informed consent
• Be willing to comply with study procedures.

Exclusion criteria

• History of chronic skin breakdown on the residual limb
• Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
• Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
• Unwillingness/inability to follow instructions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Active Comparator: Prosthetic socket standard of care

Active Comparator group

Treatment:

Device: Standard of care socket

Active Comparator: Prosthetic brimless socket

Active Comparator group

Treatment:

Device: Prosthetic brimless socket