Mediastinitis, Pain, Sternal Non-union, Sternal Wound Infection
Conditions
Keywords
open heart surgery
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) patients.
Interventions
DEVICESternaLock Rigid Fixation Plates
patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates
DEVICEwire (control)
patients will have their sternum closed using wire (stainless steel surgical wire).
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant blinded to treatment assignment until completion of study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CT Scan Evaluation of Sternal Bone Healing | 3 and 6 Months | Quantitative evaluation of sternal bone healing at 5 anatomical locations along the sternum using a 6 point quantitative scale (0= no healing and 5= complete healing) |
| Activity Based Total Visual Analog Pain Score | 6 months | Postoperative VAS pain scores (scale of 0-10 for each; 0= no pain, 10= worst pain imaginable) were evaluated as a function of resting, coughing, sneezing and general movement. The sum of these was used to derive an Activity Based Total Visual Analog Pain Score, (scale of 0-40; 0= no pain, 40= worst pain imaginable). For this primary endpoint analysis, the total score at 6 months was evaluated. |
Countries
Germany, United States
Participant flow
Recruitment details
Prospective, randomized trial at 5 US sites and 1 European site. Patient enrollment occurred between November 2008 and May 2010.
Pre-assignment details
Patients were randomized at the time of sternal closure to either rigid plate fixation or wire cerclage. A total of 140 patients were enrolled in this study (70 in each treatment group) and included in an intent to treat analysis.
Participants by arm
| Arm | Count |
|---|---|
| Wire (Control) patients will have their sternum closed using stainless steel wires. | 70 |
| Plates patients will have their sternum closed by rigid fixation using SternaLock plates. | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | Wire (Control) | Plates | Total |
|---|---|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 8.9 | 66.3 years STANDARD_DEVIATION 9.8 | 65.2 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 18 Participants | 19 Participants | 37 Participants |
| Sex: Female, Male Male | 52 Participants | 51 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 70 | 24 / 70 |
| serious Total, serious adverse events | 24 / 70 | 32 / 70 |
Outcome results
Primary
Activity Based Total Visual Analog Pain Score
Postoperative VAS pain scores (scale of 0-10 for each; 0= no pain, 10= worst pain imaginable) were evaluated as a function of resting, coughing, sneezing and general movement. The sum of these was used to derive an Activity Based Total Visual Analog Pain Score, (scale of 0-40; 0= no pain, 40= worst pain imaginable). For this primary endpoint analysis, the total score at 6 months was evaluated.
Time frame: 6 months
Population: All patients with VAS pain data at 6 months were included in the analysis of the primary endpoint Activity Based Total Visual Analog Pain Score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wire (Control) | Activity Based Total Visual Analog Pain Score | 7.28 units on a scale | Standard Deviation 4.65 |
| Plates | Activity Based Total Visual Analog Pain Score | 7.20 units on a scale | Standard Deviation 4.04 |
Comparison: Plates vs Wiresp-value: 0.93t-test, 1 sided
Primary
CT Scan Evaluation of Sternal Bone Healing
Quantitative evaluation of sternal bone healing at 5 anatomical locations along the sternum using a 6 point quantitative scale (0= no healing and 5= complete healing)
Time frame: 3 and 6 Months
Population: Patients were randomized to receive a CT scan at either 3 or 6 months. All patients who received a CT scan were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wire (Control) | CT Scan Evaluation of Sternal Bone Healing | 3 Month CT Scan (n=25 wire, n=27 plates) | 0.9 units on a scale | Standard Deviation 0.8 |
| Wire (Control) | CT Scan Evaluation of Sternal Bone Healing | 6 Month CT Scan (n=26 wire, n=23 plates) | 2.2 units on a scale | Standard Deviation 1.1 |
| Plates | CT Scan Evaluation of Sternal Bone Healing | 3 Month CT Scan (n=25 wire, n=27 plates) | 1.7 units on a scale | Standard Deviation 1.1 |
| Plates | CT Scan Evaluation of Sternal Bone Healing | 6 Month CT Scan (n=26 wire, n=23 plates) | 3.2 units on a scale | Standard Deviation 1.6 |
Comparison: 3 Month CT Scores (Plates vs Wires)p-value: 0.003t-test, 2 sided
Comparison: 6 Month CT Scores (Plates vs Wires)p-value: 0.01t-test, 2 sided