Southern Bone & Joint Study - Brimless Sockets

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Socket Designs of Transfemoral Amputees.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active Comparator: Prosthetic socket standard of care

Group Type ACTIVE_COMPARATOR

Standard of care socket

Intervention Type DEVICE

Amputees' preferred socket.

Active Comparator: Prosthetic brimless socket

Group Type ACTIVE_COMPARATOR

Prosthetic brimless socket

Intervention Type DEVICE

Study socket

Interventions

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Standard of care socket

Amputees' preferred socket.

Intervention Type DEVICE

Prosthetic brimless socket

Study socket

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes