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

Jagiellonian University

Status: Unknown

Conditions: Surgical Treatment

Treatments: Other: surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04062604

ELLFF1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria: n.a.

Trial design

350 participants in 4 patient groups

Femur fracture

Description:

Stabilization of femur fracture according to the AO fundation guidelines

Treatment:

Other: surgery

Hip alloplasty

Description:

Endoprothesis

Treatment:

Other: surgery

Knee alloplasty

Description:

Endoprothesis

Treatment:

Other: surgery

Knee arthroscopy

Description:

Resection of the meniscus lesion or anterior cruciatus ligamentum reconstruction

Treatment:

Other: surgery