Phase 3
Completed N=10
Southern Bone & Joint Study - Brimless Sockets
Socket Designs of Transfemoral Amputees.
Source: ClinicalTrials.gov NCT01416129 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Gait
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gait |
— | — |
| PRIMARY Balance and Stability |
— | — |
| PRIMARY Quality of Life |
— | — |
| PRIMARY Socket Pressure |
841; 819 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01416129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.