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OpenTrials
Completed

NCT Number: NCT01416129

Southern Bone & Joint Study - Brimless Sockets

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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Key information

Conditions

Socket Designs of Transfemoral Amputees.

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of South Florida

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care socket

Device

Amputees' preferred socket.

Prosthetic brimless socket

Device

Study socket

Primary outcomes

  1. Gait

    Time frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.

    Gait will be assessed in terms of biomechanics and spatiotemporal parameters.

  2. Balance and Stability

    Time frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.

    Balance and stability will be assessed for limits of stability and postural stability.

  3. Quality of Life

    Time frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.

    Validated surveys will be used to solicit participants' subjective experience and feedback.

  4. Socket Pressure

    Time frame: 10 minutes after fitting with both sockets

    Pressure sensors are placed on the skin and measured.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • Southern Bone & Joint Specialists, P.A.

Registry information

Official study title

Biomechanical Superiority of Brimless Versus Ischial Ramus Containment (IRC) Sub Atmospheric Transfemoral Interfaces

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 12, 2011
Registry last updated
Jun 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.