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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04062604

Acronym

ELLFF

Enrollment

350

Registered

2019-08-20

Start date

2019-09-01

Completion date

2022-09-01

Last updated

2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Treatment

Brief 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.

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.

Interventions

OTHERsurgery

surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

n.a.

Design outcomes

Primary

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

Secondary

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

Countries

Poland

Contacts

Primary ContactMarcin Bednarek

marcin.bednarek@uj.edu.pl+486030674912

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026