Status:
COMPLETED
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
Lead Sponsor:
Zimmer Biomet
Conditions:
Sternal Wound Infection
Sternal Non-union
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
Median sternotomy patients will be randomized to either wire or rigid fixation groups. A scheduled evaluation period will record clinical parameters. Enrollment has ended with one hundred forty (140) ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00819286
Start Date
November 1 2008
End Date
December 1 2011
Last Update
February 13 2018
Active Locations (6)
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1
St. Joseph's Heart and Lung Institute
Phoenix, Arizona, United States, 85013
2
University of California Davis Medical Center
Sacramento, California, United States, 95817
3
University of Chicago
Chicago, Illinois, United States, 60637
4
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120