At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 10 enrolled
Drug / intervention
Standard of care socket +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Biomechanical Superiority of Brimless Versus Ischial Ramus Containment (IRC) Sub Atmospheric Transfemoral Interfaces
In Brief
A Phase 3 clinical trial evaluating Standard of care socket and Prosthetic brimless socket for Socket Designs of Transfemoral Amputees.. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSocket Designs of Transfemoral Amputees.
CountriesUnited States
CollaboratorsSouthern Bone & Joint Specialists, P.A.
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2010
Primary CompletionJul 2011
First PostedAug 2011
Study CompletionOct 2011
TodayJul 2026
First PostedAug 12, 2011
Enrollment StartOct 1, 2010
Primary CompletionJul 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.9 years ago
Interventions
Standard of care socketdevice
Amputees' preferred socket.
Prosthetic brimless socketdevice
Study socket