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

NCT ID: NCT04062604

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-09-01

Brief Summary

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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

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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.

Conditions

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Surgical Treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Femur fracture

Stabilization of femur fracture according to the AO fundation guidelines

surgery

Intervention Type OTHER

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

Hip alloplasty

Endoprothesis

surgery

Intervention Type OTHER

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

Knee alloplasty

Endoprothesis

surgery

Intervention Type OTHER

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

Knee arthroscopy

Resection of the meniscus lesion or anterior cruciatus ligamentum reconstruction

surgery

Intervention Type OTHER

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

Interventions

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surgery

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Marcin Bednarek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcin Bednarek

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Locations

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Jagiellonian University

Krakow, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Marcin Bednarek

Role: CONTACT

+486030674912

Facility Contacts

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Marcin Bednarek

Role: primary

Other Identifiers

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ELLFF1

Identifier Type: -

Identifier Source: org_study_id

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