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

Last updated: February 12, 2020
Sponsor: Jagiellonian University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Treatment

N/A

Clinical Study ID

NCT04062604
ELLFF1
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed Patient Informed Consent

  • Patients planned for the surgical treatment

Exclusion

Exclusion Criteria: n.a.

Study Design

Total Participants: 350
Study Start date:
September 01, 2019
Estimated Completion Date:
September 01, 2022

Study 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.

Connect with a study center

  • Jagiellonian University

    Krakow,
    Poland

    Active - Recruiting

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