ELLFF: The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Femur fracture Stabilization of femur fracture according to the AO fundation guidelines |
Other: surgery
surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy
|
| Hip alloplasty Endoprothesis |
Other: surgery
surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy
|
| Knee alloplasty Endoprothesis |
Other: surgery
surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy
|
| Knee arthroscopy Resection of the meniscus lesion or anterior cruciatus ligamentum reconstruction |
Other: surgery
surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed Patient Informed Consent
-
Patients planned for the surgical treatment
Exclusion Criteria: n.a.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jagiellonian University | Krakow | Poland |
Sponsors and Collaborators
- Jagiellonian University
Investigators
- Principal Investigator: Marcin Bednarek, Jagiellonian University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ELLFF1