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NCT01559909 · ClinicalTrials.gov registry record · Phase 1

Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees

A Phase 1 study, sponsored by Stony Brook University.

Completed
Registry status
Phase 1
Development phase
10
Enrollment target

NCT01559909: Completed Phase 1 study, sponsored by Stony Brook University.

NCT01559909 is a Phase 1 study that has completed, run by Stony Brook University. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01559909, a Phase 1 study, has completed, sponsored by Stony Brook University.

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study Summary

Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb. VAS may improve stability, weight bearing, comfort, proprioception, limb health, and function. To date, there is no evidence to support whether VAS alters balance, kinematics, and kinetics when walking for TF amputees as compared to conventional socket suspension technology. Further, there is question regarding what the optimal height of the socket should be to maintain stability and function. So long as stability is not sacrificed, it may be advantageous to lower the height of the socket to allow full hip motion and improve sitting comfort. The purpose of this investigation is to assess if the socket height alters the motion of the leg and changes the way one walks when using VAS compared to conventional socket suspension technology. In this study, TF amputees will be fitted with a VAS socket that will be attached to their current prosthesis using similar alignment. Individuals will be assessed while walking on a level floor and during stair negotiation while wearing the prosthesis with the VAS socket at various socket heights as well as their current socket. Additionally, balance and socket standing and sitting comfort will be investigated.

Primary Outcome

Step length, stride length, stance time, swing time, velocity

Interventions

  • DEVICE Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2012-06
Est. Completion 2013-12
Phase Phase 1
Stony Brook University

127 total trials

What the finished NCT01559909 record still lists

NCT01559909 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare) is the first listed.

NCT01559909 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01559909 about?

NCT01559909 is a clinical study titled "Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees". Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb. VAS may improve stability, weight bearing, comfort, proprioception, limb health, and function. To date, there is ...

What is the current status of trial NCT01559909?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2012-06. Estimated completion is 2013-12.

What interventions are being tested in trial NCT01559909?

The interventions under investigation include: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare) (DEVICE).

Who is sponsoring clinical trial NCT01559909?

This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01559909's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01559909, the US trial registry maintained by the National Library of Medicine. NCT01559909 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.