CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Revo-M +2 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.

Search/NCT04239222
NCT04239222N/ACompleted
CompareCT.gov

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

Otto Bock Healthcare Products GmbH·interventional·Posted Jan 27, 2020·Updated Sep 23, 2024

In Brief

A clinical study evaluating Revo-M, Taleo, and 1 other intervention for Lower Limb Amputation Below Knee (Injury) and 2 related conditions. Completed, enrolled 27 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 27, 2020
Enrollment StartMar 10, 2020
Primary CompletionMar 11, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.4 years ago

Interventions

Revo-Mdevice

Investigational energy storage and return prosthetic foot with using novel elastic elements.

Taleodevice

Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects

Proflex XCdevice

Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects