At a glance
ClinicalIndex Comparison RecordN/ACompleted· 140 enrolled
Drug / intervention
SternaLock Rigid Fixation Plates +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized-Controlled, Multicenter Study Evaluating Primary Plating in High-Risk Median Sternotomy Patients for Osteosynthesis and Pain
In Brief
A clinical study evaluating SternaLock Rigid Fixation Plates and wire (control) for Sternal Wound Infection and 3 related conditions. Completed, enrolled 140 participants across 6 sites in 2 countries.
Detailed Summary
The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
CountriesGermany, United States
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2008
First PostedJan 2009
Primary CompletionJan 2011
Study CompletionDec 2011
TodayJul 2026
First PostedJan 8, 2009
Enrollment StartNov 1, 2008
Primary CompletionJan 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.5 years ago
Interventions
SternaLock Rigid Fixation Platesdevice
patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates
wire (control)device
patients will have their sternum closed using wire (stainless steel surgical wire).