Lower Limb FracturesNCT03091114
Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures
An observational study of Lower Limb Fractures, run by University of Witten/Herdecke at 1 site in Germany.
Trial summary
Background: A predictive factor is a measure that predicts treatment response. Decisions on internal fixations of lower limb fractures should regard predictive factors to personalize (e.g. age) treatment. However for most potentially influencing factors valid data on the predictive value is sparse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Fractures
- How many people
- 210 participants
- Where
- 1 siteGermany
- Study dates
- 27 Mar 2017to 31 Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lower limb fractures.
Who may be able to join
- Adult patients (≥18 years) with isolated fractures scheduled for urgent or semi-urgent surgery using internal fixations because of the following lower limb fractures will be included:
- Tibia fractures
- Femur fractures
- Ankle fractures
- Calcaneal fractures
Who cannot join
- Periprosthetic fractures
- Insufficient knowledge of the German language
- Strong cognitive impairment
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim
Cologne, North-Rhine-Westfalia, 51109
About this study
Official title: Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures: a Prospective Cohort Study
Background:
A predictive factor is a measure that predicts treatment response. Decisions on internal fixations of lower limb fractures should regard predictive factors to personalize (e.g. age) treatment. However for most potentially influencing factors valid data on the predictive value is sparse.
Read more
Objectives:
The objective of this study is to identify predictive factors and quantify their predictive ability for treatment failure in patients with limb fractures treated with osteosynthesis.
Methods:
Patients Adult patients (≥18 year) with isolated fractures scheduled for urgent or semi-urgent surgery using internal fixations because of lower limb fractures.
The predictive value of the following exposures will be analyzed:
- Age
- Gender
- Diabetes
- Smoking status
- Body Mass Index
- Open fractures
- Peripheral arterial disease
Outcome The outcome will be (time to) reoperation of the same fracture because of failure of internal fixation due to nonunion or implant failure.
Study design A prospective observational cohort study will be performed. Sample size 300 patients will be included.
Statistical analysis:
For the main analysis a multivariate stratified Cox proportional hazard model will be used. The Model will be stratified according to the indication. In the Cox proportional hazard model all predictive factors will be entered simultaneously to quantify the independent influence (adjusted for all other factors) of each factor. The strength of prediction will be described with hazard rations and their corresponding 95% confidence intervals.
Read the detailed description
see study protocol: https://uni-wh.de/fileadmin/user_upload/03_G/07_Humanmedizin/05_Institute/IFOM/IFF-PROFAK_Protocol.pdf
- Conditions
- Lower Limb Fractures
- Keywords
- fractures, risk prediction
- Medical subject headings
- Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of internal fixation
Failure of internal fixation due to nonunion or implant failure
Measured: 6 months +/- 2 weeks (survival analysis)
Secondary outcomes (2)
Pain
Pain numerical rating scale (NRS) >3
Measured: 6 months +/- 2 weeks
Physical functioning
E.g. climbing stairs
Measured: 6 months +/- 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start27 Mar 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Limb FracturesStudies 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
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Mathes, University of Witten/Herdecke
- Investigators
- Tim Mathes, Dr., Principal investigator, University of Witten/Herdecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091114
- Sponsor's protocol ID
- V01-A0
- Status last verified
- Oct 2018
- First submitted
- 13 Mar 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data on predictive factors and outcomes will be made available. Published as supplemental material open access (anticipated 12/2018).
Publications
Prediger B, Tjardes T, Probst C, Heu-Parvaresch A, Glatt A, Dos Anjos DR, Bouillon B, Mathes T. Factors predicting failure of internal fixations of fractures of the lower limbs: a prospective cohort study. BMC Musculoskelet Disord. 2021 Sep 16;22(1):798. doi: 10.1186/s12891-021-04688-6.
PubMed 34530793
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for Failure of Internal Fixations of Lower Limb Fractures: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03091114
- Acronym / sponsor ID
- V01-A0
- Conditions
- Lower Limb Fractures
- Keywords
- fractures, risk prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 27 Mar 2017 (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.
Background:
A predictive factor is a measure that predicts treatment response. Decisions on internal fixations of lower limb fractures should regard predictive factors to personalize (e.g. age) treatment. However for most potentially influencing factors valid data on the predictive value is sparse.
Objectives:
The objective of this study is to identify predictive factors and quantify their predictive ability for treatment failure in patients with limb fractures treated with osteosynthesis.
Methods:
Patients Adult patients (≥18 year) with isolated fractures scheduled for urgent or semi-urgent surgery using internal fixations because of lower limb fractures.
The predictive value of the following exposures will be analyzed:
- Age
- Gender
- Diabetes
- Smoking status
- Body Mass Index
- Open fractures
- Peripheral arterial disease
Outcome The outcome will be (time to) reoperation of the same fracture because of failure of internal fixation due to nonunion or implant failure.
Study design A prospective observational cohort study will be performed. Sample size 300 patients will be included.
Statistical analysis:
For the main analysis a multivariate stratified Cox proportional hazard model will be used. The Model will be stratified according to the indication. In the Cox proportional hazard model all predictive factors will be entered simultaneously to quantify the independent influence (adjusted for all other factors) of each factor. The strength of prediction will be described with hazard rations and their corresponding 95% confidence intervals.
Detailed description
see study protocol: https://uni-wh.de/fileadmin/user_upload/03_G/07_Humanmedizin/05_Institute/IFOM/IFF-PROFAK_Protocol.pdf
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lower limb fractures.
Key inclusion criteria (5 listed)
- Adult patients (≥18 years) with isolated fractures scheduled for urgent or semi-urgent surgery using internal fixations because of the following lower limb fractures will be included:
- Tibia fractures
- Femur fractures
- Ankle fractures
- Calcaneal fractures
Key exclusion criteria (3 listed)
- Periprosthetic fractures
- Insufficient knowledge of the German language
- Strong cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Failure of internal fixation
Time frame: 6 months +/- 2 weeks (survival analysis)
Failure of internal fixation due to nonunion or implant failure
2 secondary outcomes
Pain
Time frame: 6 months +/- 2 weeks
Physical functioning
Time frame: 6 months +/- 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 34530793Prediger B, Tjardes T, Probst C, Heu-Parvaresch A, Glatt A, Dos Anjos DR, Bouillon B, Mathes T. Factors predicting failure of internal fixations of fractures of the lower limbs: a prospective cohort study. BMC Musculoskelet Disord. 2021 Sep 16;22(1):798. doi: 10.1186/s12891-021-04688-6.
- Individual participant dataSharing planned: Yes. All data on predictive factors and outcomes will be made available. Published as supplemental material open access (anticipated 12/2018).
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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.
Tim Mathes, Dr. principal investigator
University of Witten/Herdecke
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 Lower Limb Fractures, run by University of Witten/Herdecke at 1 site in Germany.
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 5 inclusion and 3 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 9 Oct 2018. 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 Germany. 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?
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?
Failure of internal fixation (time frame: 6 months +/- 2 weeks (survival analysis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03091114, which also lists 1 linked publication.
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 Oct 2018.