Surgical TreatmentELLFFNCT04062604
The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment
An observational study of Surgical Treatment, run by Jagiellonian University at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Treatment
- What is being tested?
- surgery
- How many people
- 350 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2019to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients planned for the surgical interventions
Who may be able to join
- Signed Patient Informed Consent
- Patients planned for the surgical treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Jagiellonian University
Krakow
Marcin Bednarek
About this study
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.
Read the 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.
- Conditions
- Surgical Treatment
- Being tested
- surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryOther
surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| Femur fracture | Stabilization of femur fracture according to the AO fundation guidelines Receives: Other: surgery | |
| Hip alloplasty | Endoprothesis Receives: Other: surgery | |
| Knee alloplasty | Endoprothesis Receives: Other: surgery | |
| Knee arthroscopy | Resection of the meniscus lesion or anterior cruciatus ligamentum reconstruction Receives: Other: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective assessment of the lower limb function
Questionnaire, score scale - according to the description in questionnaire, lower score- worse outcome
Measured: 12 month
Objective assessment of the lower limb function
Physical exam
Measured: 12 month
Secondary outcomes (2)
Subjective assessment of the lower limb function
Questionnaire, score scale - according to the description in questionnaire, lower score- worse outcome
Measured: 3, 6, 24 months
Objective assessment of the lower limb function
Physical exam
Measured: 3, 6, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start1 Sep 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcin Bednarek, Jagiellonian University
- Investigators
- Marcin Bednarek, Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062604
- Sponsor's protocol ID
- ELLFF1
- Acronym
- ELLFF
- Status last verified
- Feb 2020
- First submitted
- 14 Apr 2019
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment
- ClinicalTrials.gov ID
- NCT04062604
- Acronym / sponsor ID
- ELLFF / ELLFF1
- Conditions
- Surgical Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Femur fracture | – | Other: surgeryStabilization of femur fracture according to the AO fundation guidelines |
| Hip alloplasty | – | Other: surgeryEndoprothesis |
| Knee alloplasty | – | Other: surgeryEndoprothesis |
| Knee arthroscopy | – | Other: surgeryResection of the meniscus lesion or anterior cruciatus ligamentum reconstruction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients planned for the surgical interventions
Key inclusion criteria (2 listed)
- Signed Patient Informed Consent
- Patients planned for the surgical treatment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgerysurgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy | Other | Femur fracture, Hip alloplasty, Knee alloplasty, Knee arthroscopy |
Primary outcome
Subjective assessment of the lower limb function
Time frame: 12 month
Questionnaire, score scale - according to the description in questionnaire, lower score- worse outcome
Objective assessment of the lower limb function
Time frame: 12 month
Physical exam
2 secondary outcomes
Subjective assessment of the lower limb function
Time frame: 3, 6, 24 months
Objective assessment of the lower limb function
Time frame: 3, 6, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin Bednarek principal investigator
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Treatment, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcin Bednarek (+486030674912, marcin.bednarek@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective assessment of the lower limb function (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.