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The effect of a novel foot prosthesis on biomechanical characteristics, functional capacity and lifestyle patterns of unilateral transtibial amputees living in South Africa - Trial PACTR202006792038036

Access comprehensive clinical trial information for PACTR202006792038036 through Pure Global AI's free database. This Not Applicable trial is sponsored by Ossur South Africa and is currently Completed. The study focuses on Injury, Occupational Diseases, Poisoning; Musculoskeletal Diseases; Orthopaedics.

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PACTR202006792038036
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Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR202006792038036
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The effect of a novel foot prosthesis on biomechanical characteristics, functional capacity and lifestyle patterns of unilateral transtibial amputees living in South Africa
The effect of a novel energy storage and return foot prosthesis (Pro-flex foot) on biomechanics, function and lifestyle patterns, compared to the gold standard energy storage and return foot prosthesis (Vari-flex foot) and a conventional solid ankle cushioned foot (SACH) prosthesis in South African transtibial amputees

Sponsor & Location

Ossur South Africa

Ossur

South Africa

Timeline & Enrollment

Not Applicable

Jul 10, 2017

Oct 04, 2018

Summary

Currently, most individuals with transtibial (TTA) living in South Africa use a conventional solid-ankle cushioned-heel foot prosthesis. This type of prosthesis is a rudimentary prosthesis: a key disadvantage is the deviation in gait pattern away from โ€œnormal gaitโ€. In recent years, advanced energy storage and return (ESAR) prostheses have become more readily available to individuals with TTA, and have been designed specifically to provide a โ€œmore normal gaitโ€ in the TTA population, through various mechanisms. The present study is the first study to assess the differences in biomechanical characteristics, functional capacity, perceptions of quality of life and physical activity patterns in a novel ESAR foot (Pro-Flex foot, Ossur, Iceland), the current gold standard ESAR foot (Vari-Flex foot, Ossur, Iceland) and the conventional foot in a sample of South African individuals with unilateral TTA.

ICD-10 Classifications

Sequelae of injuries, of poisoning and of other consequences of external causes
Injury, poisoning and certain other consequences of external causes
Other postprocedural musculoskeletal disorders
Other specified injuries of upper limb, level unspecified
Other injuries of unspecified body region

Data Source

Pan Africa Clinical Trials Registry

PACTR202006792038036

Device Trial