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NCT01537211 · ClinicalTrials.gov registry record · NA

Functional Outcomes in Dysvascular Transfemoral Amputees

A NA study, sponsored by Shirley Ryan AbilityLab.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT01537211: Completed NA study, sponsored by Shirley Ryan AbilityLab.

NCT01537211 is a NA study that has completed, run by Shirley Ryan AbilityLab. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01537211, a NA study, has completed, sponsored by Shirley Ryan AbilityLab.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

In older adults, poor circulation in the lower extremities leads to serious health complications including limb loss. In addition, individuals with dysvascular disease also suffer from other co-morbidities like diabetes, coronary and cerebrovascular disease. An individual with a transfemoral (TF) amputation is usually fitted with a prosthetic limb to assist with function, including a prosthetic knee and a prosthetic foot. Currently, dysvascular amputees are given a prosthetic knee based on the basic expectation that they will be functionally stable. This consideration does not address higher levels of function like walking at multiple speeds and over uneven ground. Also, dysvascular amputees are not able to counteract their co-morbidities with a more active lifestyle. Walking is less energy efficient; their traditional prostheses may cause early onset of fatigue and induce a fear of falling. Newer microprocessor knees enable patients with transfemoral amputations to walk on different surfaces and at multiple cadences through better control in swing and stance phases of gait. The impact of the functional differences in the prostheses is not clear and requires additional investigation to clarify the choice of the most appropriate functional prosthesis. The purpose of this study is to compare the functional outcomes with the traditional mechanical knee versus the microprocessor knee (C-leg) in transfemoral amputees.

Primary Outcome

The difference in social mobility (as seen by GPS) between the 2 devices will be measured.

Interventions

  • DEVICE C leg compared to subject's mechanical leg (Otto Bock)

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2011-08
Est. Completion 2019-04
Phase NA
Shirley Ryan AbilityLab

138 total trials

What the finished NCT01537211 record still lists

NCT01537211 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which C leg compared to subject's mechanical leg (Otto Bock) is the first listed.

NCT01537211 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01537211 about?

NCT01537211 is a clinical study titled "Functional Outcomes in Dysvascular Transfemoral Amputees". In older adults, poor circulation in the lower extremities leads to serious health complications including limb loss. In addition, individuals with dysvascular disease also suffer from other co-morbidities like diabetes, coronary and cerebrovascular disease. An individual with a transfemoral (TF) am...

What is the current status of trial NCT01537211?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2011-08. Estimated completion is 2019-04.

What interventions are being tested in trial NCT01537211?

The interventions under investigation include: C leg compared to subject's mechanical leg (Otto Bock) (DEVICE).

Who is sponsoring clinical trial NCT01537211?

This trial is sponsored by Shirley Ryan AbilityLab, which has 138 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01537211's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01537211, the US trial registry maintained by the National Library of Medicine. NCT01537211 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.