A Prospective, Randomized-Controlled, Multicenter Study Evaluating Primary Plating in High-Risk Median Sternotomy Patients for Osteosynthesis and Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zimmer Biomet
- Enrollment
- 140
- Locations
- 6
- Primary Endpoint
- Activity Based Total Visual Analog Pain Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participant blinded to treatment assignment until completion of study.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
wire (control)
patients will have their sternum closed using wire (stainless steel surgical wire).
Intervention: wire (control) (Device)
SternaLock Rigid Fixation Plates
patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates.
Intervention: SternaLock Rigid Fixation Plates (Device)
Outcomes
Primary Outcomes
Activity Based Total Visual Analog Pain Score
Time Frame: 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
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported