NCT02439463

Brief Summary

The present study assesses the health-related quality of life and the locomotor capabilities major traumatic lower limb amputees who use prosthesis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

2.6 years

First QC Date

May 5, 2015

Last Update Submit

February 21, 2018

Conditions

Amputees

Outcome Measures

Primary Outcomes (2)

  • The health-related quality of life measured by HRQoL score

    2-5 years

  • Locomotor capabilities of traumatic below-knee amputees with prothesis

    2-5 years

Secondary Outcomes (2)

  • 15D health-related quality of life instrument

    2-5 years

  • Prothesis Evaluation Questionnaire

    2-5 yeats

Interventions

Below-knee amputationPROCEDURE

Patients with traumatic below-knee amputation.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Below-knee amputees who use limb prosthesis

You may qualify if:

  • Below-knee prosthesis users with amputation due to trauma
  • age \>18

You may not qualify if:

  • \. Patients with no prosthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Uusimaa, 00029, Finland

Location

Study Officials

  • Erkki J Tukiainen, MD,PhD

    Helsinki University Central Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 8, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

FI(1)