- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04062604
The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment (ELLFF)
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Marcin Bednarek
- Phone Number: +486030674912
- Email: marcin.bednarek@uj.edu.pl
Study Locations
-
-
-
Krakow, Poland
- Recruiting
- Jagiellonian University
-
Contact:
- Marcin Bednarek
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Signed Patient Informed Consent
- Patients planned for the surgical treatment
Exclusion Criteria: n.a.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Femur fracture
Stabilization of femur fracture according to the AO fundation guidelines
|
surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy
|
Hip alloplasty
Endoprothesis
|
surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy
|
Knee alloplasty
Endoprothesis
|
surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy
|
Knee arthroscopy
Resection of the meniscus lesion or anterior cruciatus ligamentum reconstruction
|
surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective assessment of the lower limb function
Time Frame: 12 month
|
Questionnaire, score scale - according to the description in questionnaire, lower score- worse outcome
|
12 month
|
Objective assessment of the lower limb function
Time Frame: 12 month
|
Physical exam
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective assessment of the lower limb function
Time Frame: 3, 6, 24 months
|
Questionnaire, score scale - according to the description in questionnaire, lower score- worse outcome
|
3, 6, 24 months
|
Objective assessment of the lower limb function
Time Frame: 3, 6, 24 months
|
Physical exam
|
3, 6, 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcin Bednarek, Jagiellonian University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ELLFF1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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