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

• Conditions: Surgical Treatment
• Interventions: Other: surgery

• Registration Number: NCT04062604
• Lead Sponsor: Jagiellonian University

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.

Study Timeline

• Study First Submitted: 2019-04-14
• Study First Submitted QC: 2019-08-18
• Study First Posted: 2019-08-20
• Study Start: 2019-09-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17
• Primary Completion: 2020-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

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

Exclusion Criteria

n.a.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Knee alloplasty	surgery	Endoprothesis
Knee arthroscopy	surgery	Resection of the meniscus lesion or anterior cruciatus ligamentum reconstruction
Femur fracture	surgery	Stabilization of femur fracture according to the AO fundation guidelines
Hip alloplasty	surgery	Endoprothesis

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jagiellonian University; 🇵🇱 Krakow, Poland