N/A
N=140
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
Sternal Wound Infection · Sternal Non-union · Pain · Mediastinitis
Bottom Line
View on ClinicalTrials.gov: NCT00819286 ↗Enrolled (actual)
140
Serious AEs
40.0%
Results posted
Mar 2012
Primary outcome: Primary: CT Scan Evaluation of Sternal Bone Healing — 0.9; 1.7; 2.2; 3.2 units on a scale — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SternaLock Rigid Fixation Plates (Device); wire (control) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CT Scan Evaluation of Sternal Bone Healing |
0.9; 1.7; 2.2; 3.2 | 0.003 sig |
| PRIMARY Activity Based Total Visual Analog Pain Score |
7.28; 7.20 | 0.93 |
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.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing median sternotomy;
- Patients eighteen (18) years of age or older;
- Patients presenting two or more risk factors such as diabetes mellitus, Chronic Obstructive Pulmonary Disease, obesity (BMI > 30), osteoporosis, Renal failure, Chronic steroid use, Immunosuppression, Redo sternotomy, Neurologic dysfunction severely affecting ambulation,
- Off mid-line sternotomy
- bilateral IMA use
- Long cardio-pulmonary bypass runs
- Transverse fractures of the sternum
Exclusion Criteria
- Patients with a non-standard sternotomy;
- Patients with an off-midline sternotomy that reduced the bony margin to <2mm
- Patients under eighteen (18) years of age;
- Patients that are pregnant or currently lactating;
- Patients presenting intra-operative conditions that would require the use of rigid fixation and/or additional post-sternotomy mechanical support beyond wire cerclage due to surgical evaluation,
- Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure,
- Patients presenting emergent/salvage cardiac acuity as defined per the Society of Thoracic Surgeons (STS) guidelines: i.e., patients undergoing cardiopulmonary resuscitation en route to the operating room or prior to induction of anesthesia;
- Patients undergoing post-operative revision procedures that treat the original sternotomy in such a way as to affect outcome (antibiotic irrigation, debridement or other treatment to the osteotomy);
- Patients unwilling or unable to return for follow-up;
- Lacking the ability to follow instructions;
- Intraoperative death.
Data sourced from ClinicalTrials.gov (NCT00819286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.