NCT04239222

Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot

Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New Energy Storage and Return Prosthetic Foot

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Otto Bock Healthcare Products GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.

Detailed description

The purpose of the Revo-M Study is to characterize differences in performance and patient reported outcomes between the Revo investigational prosthetic foot and a comparative prosthetic foot (Taleo or Proflex XC) when compared to the control foot which is the subject's currently used energy storage and return (ESR) prosthetic foot. The data obtained from this study may also serve to determine the long-term performance of Revo.

Conditions

• Lower Limb Amputation Below Knee (Injury)
• Lower Limb Amputation Above Knee (Injury)
• Lower Limb Amputation Knee

Interventions

Type	Name	Description
DEVICE	Revo-M	Investigational energy storage and return prosthetic foot with using novel elastic elements.
DEVICE	Taleo	Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects
DEVICE	Proflex XC	Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects

Timeline

• Start date: 2020-03-10
• Primary completion: 2022-03-11
• Completion: 2022-03-11
• First posted: 2020-01-27
• Last updated: 2024-09-23
• Results posted: 2024-09-23

Locations

4 sites across 1 country: United States