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

Surgical Treatment Clinical Trial

— ELLFF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04062604
• Other study ID #: ELLFF1
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2020
• Source: Jagiellonian University
• Contact: Marcin Bednarek
• Phone: +486030674912
• Email: marcin.bednarek[@]uj.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Signed Patient Informed Consent

• Patients planned for the surgical treatment

Exclusion Criteria: n.a.

Related Conditions & MeSH terms

• Femoral Fractures
• Surgical Treatment

Intervention

Other:
• surgery
surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy

Locations

Country	Name	City	State
Poland	Jagiellonian University	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective assessment of the lower limb function	Questionnaire, score scale - according to the description in questionnaire, lower score- worse outcome	12 month
Primary	Objective assessment of the lower limb function	Physical exam	12 month
Secondary	Subjective assessment of the lower limb function	Questionnaire, score scale - according to the description in questionnaire, lower score- worse outcome	3, 6, 24 months
Secondary	Objective assessment of the lower limb function	Physical exam	3, 6, 24 months