Osteosynthesis
ProcedureOsteosynthesis of posterior tibial plateau fracture with a posterior tibial plateau plate
NCT Number: NCT03540719
This protocol concerns an academic, multicentric, and prospective clinical trial. In this study the investigators will evaluate the recently approved WAVE-plate (7S Medical) for open reduction and internal fixation and buttressing of the posterior proximal tibial column via a posteromedial reversed L-shaped approach. The reversed L-shaped approach has been shown as a safe technique with adequate visualisation of the posterior tibial surface. The investigators will thoroughly evaluate all important clinical, radiological and functional variables. The functional outcome will be reported in patient reported outcome measures by means of the validated Knee injury and Osteoarthritis Outcome Score (KOOS).
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Notify Me18 year–99 year
All sexes
Observational
UZ Brussel, Brussels, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Osteosynthesis of posterior tibial plateau fracture with a posterior tibial plateau plate
Time frame: 1 year
Total Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire to measure patient's opinion about his or her knee and the associatede problems.
Time frame: 1 year
Visual analogue scale (VAS) to indicate the daily pain level.
Time frame: 1 year
Recording of demographic and fracture-related characteristics.
Time frame: 1 year
Parameters derived from CT and RX.
Time frame: 1-7 days post-operatively, 8 weeks, 12 weeks, 6 months, 9 months, 1 year
Recording of complications: infection, nonunion, wound related problems, implant related complaints, compartment syndrome, neurological disorder, muscle atrophy and deep vein thrombosis.
Harm Hoekstra, prof. dr.
Other
Acronym: Proxtib
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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