An observational study in Lower Limb Fractures, sponsored by University of Witten/Herdecke. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by University of Witten/Herdecke · Observational
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:
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.
see study protocol: https://uni-wh.de/fileadmin/user_upload/03_G/07_Humanmedizin/05_Institute/IFOM/IFF-PROFAK_Protocol.pdf
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 210 is above the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of Witten/Herdecke is the lead sponsor of 38 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with lower limb fractures.
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:
Exclusion Criteria:
Failure of internal fixation
Failure of internal fixation due to nonunion or implant failure
Time frame: 6 months +/- 2 weeks (survival analysis)
Pain
Pain numerical rating scale (NRS) \>3
Time frame: 6 months +/- 2 weeks
Physical functioning
E.g. climbing stairs
Time frame: 6 months +/- 2 weeks
Plan to share: Yes — All data on predictive factors and outcomes will be made available. Published as supplemental material open access (anticipated 12/2018).
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Witten/Herdecke