Traumatic Below-knee Amputees With Prosthetics: Health-re... | NCT02439463

Studies
Traumatic Below-knee Amputees With Prosthetics: Health-related Quality of Life and Locomotor Capabilities

NCT02439463

Sponsor

Helsinki University Central Hospital

Status

Completed

Last Update Posted

Feb 22, 2018Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Amputees

Interventions

Below-knee amputation

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015Actual

Primary Completion Date

Jan 2018Actual

Completion Date

Jan 2018Actual

First Submitted Date

May 5, 2015

First Submission Date that Met QC Criteria

May 6, 2015

First Posted Date

May 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2018

Last Update Posted Date

Feb 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

A cross sectional study based on a retrospective review of prosthetic using major traumatic lower limb amputees' demographic and clinical details together with HRQoL and locomotor capabilities patient-reported outcome measures.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Below-knee amputation	Procedure	Patients with traumatic below-knee amputation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
15D health-related quality of life instrument		2-5 years
Prothesis Evaluation Questionnaire		2-5 yeats

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with no prosthesis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Below-knee amputees who use limb prosthesis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erkki J Tukiainen, MD,PhD	Helsinki University Central Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital		Helsinki	Uusimaa	00029	Finland