Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain (RESTORE)

Zimmer Biomet

Status: Completed

Conditions: Mediastinitis; Sternal Non-union; Sternal Wound Infection; Pain

Treatments: Device: SternaLock Rigid Fixation Plates; Device: wire (control)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00819286

07071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

wire (control)

Active Comparator group

Description:

patients will have their sternum closed using wire (stainless steel surgical wire).

Treatment:

Device: wire (control)

SternaLock Rigid Fixation Plates

Experimental group

Description:

patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates.

Treatment:

Device: SternaLock Rigid Fixation Plates