The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment (ELLFF)

February 12, 2020 updated by: Marcin Bednarek, Jagiellonian University
The goal of this study is the evaluation of lower limb function and the quaility of life of the patients after femur fracture operation treatment. LLTQ (Lower-Limb Tasks Questionnaire), LEFS (Lower Extremity Funcional Scale), LLFI-10 (Lower Limb Functional Index - 10) and LLFI (Lower Limb Functional Index) will be used for all the patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All four questionnaires (LLTQ, LEFS LLFI-10 and LLFI) will be translated and adopted to the Polish conditions. The detailed medical/ epidemiological history will be collected in each patient. The fracture will be assessed based on the x-ray examination and will be qualified according to AO classification. NRS (Numerical Rating Scale) will be used to assess the pain intensity. SF36, QoL, CSQ, COPE and HADS questionnaire will be used to evaluate patient's the quality of life (subjective assessment). First assessment will be done before operation and then after 3, 6, 12, 24 month postoperation treatment.

With this main study, there is a plan to assess not only femur fractures patients, but the investigators would like to have addtional groups of the patients with hip and knee allopasty and knee arthroscopy with slightly different follow-up period: before the oparation, 1 and 12 month after the treatment.

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Krakow, Poland
        • Recruiting
        • Jagiellonian University
        • Contact:
          • Marcin Bednarek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients planned for the surgical interventions

Description

Inclusion Criteria:

  • Signed Patient Informed Consent
  • Patients planned for the surgical treatment

Exclusion Criteria: n.a.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Femur fracture
Stabilization of femur fracture according to the AO fundation guidelines
surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy
Hip alloplasty
Endoprothesis
surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy
Knee alloplasty
Endoprothesis
surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy
Knee arthroscopy
Resection of the meniscus lesion or anterior cruciatus ligamentum reconstruction
surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective assessment of the lower limb function
Time Frame: 12 month
Questionnaire, score scale - according to the description in questionnaire, lower score- worse outcome
12 month
Objective assessment of the lower limb function
Time Frame: 12 month
Physical exam
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective assessment of the lower limb function
Time Frame: 3, 6, 24 months
Questionnaire, score scale - according to the description in questionnaire, lower score- worse outcome
3, 6, 24 months
Objective assessment of the lower limb function
Time Frame: 3, 6, 24 months
Physical exam
3, 6, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marcin Bednarek, Jagiellonian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

April 14, 2019

First Submitted That Met QC Criteria

August 18, 2019

First Posted (Actual)

August 20, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • ELLFF1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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