A Prospective, Randomized-Controlled, Multicenter Study Evaluating Primary Plating in High-Risk Median Sternotomy Patients for Osteosynthesis and Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Activity Based Total Visual Analog Pain Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participant blinded to treatment assignment until completion of study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
wire (control)
patients will have their sternum closed using wire (stainless steel surgical wire).
干预措施: wire (control) (Device)
SternaLock Rigid Fixation Plates
patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates.
干预措施: SternaLock Rigid Fixation Plates (Device)
结局指标
主要结局
Activity Based Total Visual Analog Pain Score
时间窗: 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.
CT Scan Evaluation of Sternal Bone Healing
时间窗: 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)
次要结局
未报告次要终点