ClinicalTrials.gov identifier: NCT02678247
Purpose: The overall objective of this study is to provide a more comfortable and functional prosthetic socket for people with transfemoral amputation that will ultimately improve their quality of life.
Study type: Interventional
Study design: Randomized, efficacy study, crossover assignment, single blind
Estimated enrollment: 30
Eligibility criteria: Both genders eligible; ages 21 years and older. Patients must have unilateral transfemoral amputation; have used a prosthesis for 2 years or more; have a residual limb that is stable in volume and free from wounds; be physically fit enough to participate performance tests (K-3 or K-4); have no previous experience of the subischial socket; be able to complete all visits for the duration of the protocol; and be able to speak and read English. Excludes patients with a residual limb femur of less than 5 inches or comorbidities that affect function, including neurologic abnormalities.
Study start date: April 2016
Estimated study completion date: September 2018
Estimated primary completion date: The final collection date for primary outcome measures will be September 2018.
Primary outcome measures: Difference in socket comfort score between ischial containment (IC) socket and NU-FlexSIV socket at 1 week, 3 weeks and 6 weeks of everyday socket use for each socket.
Secondary outcome measures: Difference in walking speed, step length, hip extension, hip range of motion and trunk motion; difference in Orthotics Prosthetics Users’ Survey Lower Extremity Functional Status Measure; Orthotics Prosthetics Users’ Survey Health-Related Quality of Life Index; and Orthotics Prosthetics Users’ Survey Satisfaction; difference in 5-Time Rapid Sit-to-Stand Test, Four-Square-Step Test and T-Test of Agility between the IC socket and the NU-FlexSIV socket
Sponsors and collaborators: Northwestern University, United States Department of Defense, Jesse Brown VA Medical Center, and Scheck and Siress Prosthetics Orthotics.
Information acquired from: Stefania Fatone, PhD, BPO(Hons), Northwestern University, via clinicaltrials.gov
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