The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Objective assessment of the lower limb function
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed Patient Informed Consent
- •Patients planned for the surgical treatment
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Objective assessment of the lower limb function
Time Frame: 12 month
Physical exam
Subjective assessment of the lower limb function
Time Frame: 12 month
Questionnaire, score scale - according to the description in questionnaire, lower score- worse outcome
Secondary Outcomes
- Subjective assessment of the lower limb function(3, 6, 24 months)
- Objective assessment of the lower limb function(3, 6, 24 months)
Investigators
Marcin Bednarek
Principal Investigator
Jagiellonian University