Femur Distal FractureNCT05163795
Distal Femur Fracture Nonunion - Statistical Analysis Plan
An observational study of Femur Distal Fracture and Nonunion of Fracture, run by Töölö Hospital at 1 site in Finland.
Trial summary
Here the investigators describe the statistical analysis plan for the study assessing the prediction of fracture nonunion leading to secondary surgery in patients with distal femur fractures. Read more about this study
- Who is it for?
- Ages 16 to 110 years
- Conditions the study is for
- Femur Distal Fracture, Nonunion of Fracture
- What is being tested?
- Lateral locking plate
- Type of treatment
- Surgery or procedure
- How many people
- 299 participants
- Where
- 1 siteFinland
- Study dates
- 15 May 2019to 15 Aug 2023
- 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 16 to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study is a retrospective cohort study conducted in level 1 trauma center at the Helsinki University Hospital with a catchment population of around one million for these fractures. All patients with a distal femur fracture treated at our institution between 2009 and 2018 were screened for eligibility.
Who may be able to join
- Age > 16 years
- AO/OTA type A or C distal femur fracture
- Fracture located on the metaphyseal area of the distal femur (square method)
- Operative treatment in the Helsinki University Hospital with a distal femur anatomic lateral locking plate
- Operative treatment within 1 month after trauma
- Operative treatment between years 2009 and 2018
Who cannot join
- Stress fracture
- Pathological fracture
- An epicondylar or subchondral fracture
- A ligament sprain in distal femur
- Treatment with a double-plating method or with both plate and nail
- Non-surgical treatment and patients who died before the treatment
- Treatment with an unconventional plate (other than distal femur plate)
- Patients whose follow-up criteria not fulfilled
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital
Helsinki, 00029
About this study
Official title: Prediction of Fracture Nonunion Leading to Secondary Surgery in Patients With Distal Femur Fractures - Statistical Analysis Plan
Here the investigators describe the statistical analysis plan for the study assessing the prediction of fracture nonunion leading to secondary surgery in patients with distal femur fractures.
Read the detailed description
See attached PDF.
- Conditions
- Femur Distal Fracture, Nonunion of Fracture
- Being tested
- Lateral locking plate
- Keywords
- Prediction, Distal femur fracture, Nonunion, Statistical analysis plan
- Medical subject headings
- Femoral Fractures, Distal, Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral locking plateProcedure or surgery
Plating of the distal femur fracture with lateral locking plate.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation
Reoperation due to fracture nonunion
Measured: Within 36 months after the initial trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start15 May 2019
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur Distal FractureStudies 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
- Retrospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Töölö Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heini Sainio, Töölö Hospital
- Investigators
- Jan Lindahl, MD, PhD, Study director, Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163795
- Sponsor's protocol ID
- Distal Femur Fractures - SAP
- Status last verified
- May 2024
- First submitted
- 15 Dec 2021
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Fracture Nonunion Leading to Secondary Surgery in Patients With Distal Femur Fractures - Statistical Analysis Plan
- ClinicalTrials.gov ID
- NCT05163795
- Acronym / sponsor ID
- Distal Femur Fractures - SAP
- Conditions
- Femur Distal Fracture, Nonunion of Fracture
- Keywords
- Prediction, Distal femur fracture, Nonunion, Statistical analysis plan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Töölö HospitalUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 20 Dec 2021 (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.
Here the investigators describe the statistical analysis plan for the study assessing the prediction of fracture nonunion leading to secondary surgery in patients with distal femur fractures.
Detailed description
See attached PDF.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study is a retrospective cohort study conducted in level 1 trauma center at the Helsinki University Hospital with a catchment population of around one million for these fractures. All patients with a distal femur fracture treated at our institution between 2009 and 2018 were screened for eligibility.
Key inclusion criteria (6 listed)
- Age > 16 years
- AO/OTA type A or C distal femur fracture
- Fracture located on the metaphyseal area of the distal femur (square method)
- Operative treatment in the Helsinki University Hospital with a distal femur anatomic lateral locking plate
- Operative treatment within 1 month after trauma
Key exclusion criteria (8 listed)
- Stress fracture
- Pathological fracture
- An epicondylar or subchondral fracture
- A ligament sprain in distal femur
- Treatment with a double-plating method or with both plate and nail
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 |
|---|---|---|
| Lateral locking platePlating of the distal femur fracture with lateral locking plate. | Procedure or surgery | – |
Primary outcome
Reoperation
Time frame: Within 36 months after the initial trauma
Reoperation due to fracture nonunion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- PublicationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jan Lindahl, MD, PhD study director
Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
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 Femur Distal Fracture and Nonunion of Fracture, run by Töölö Hospital at 1 site in Finland.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 9 May 2024. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation (time frame: Within 36 months after the initial trauma). 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 9 May 2024.