Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain

NCT ID: NCT00819286

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

wire (control)

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

Group Type: ACTIVE_COMPARATOR

wire (control)

Intervention Type: DEVICE

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

SternaLock Rigid Fixation Plates

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

Group Type: EXPERIMENTAL

SternaLock Rigid Fixation Plates

Intervention Type: DEVICE

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

Interventions

SternaLock Rigid Fixation Plates

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

Intervention Type: DEVICE

wire (control)

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jai Raman, MD

Role: STUDY_CHAIR

University of Chicago

Michael Wong, MD

Role: PRINCIPAL_INVESTIGATOR

University of California Davis Medical Center, Sacramento, CA

Brian DeGuzmann, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Medical Center, Phoenix, AZ

Sven Lehmann, MD

Role: PRINCIPAL_INVESTIGATOR

Leipzig Heart Center, Leipzig, Germany

Kenton Zehr, MD

Role: PRINCIPAL_INVESTIGATOR

Scott & White Memorial Hospital, Temple, TX

H Edward Garrett, Jr, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Memorial Hospital, Memphis, TN

Locations

St. Joseph's Heart and Lung Institute

Phoenix, Arizona, United States

University of California Davis Medical Center

Sacramento, California, United States

University of Chicago

Chicago, Illinois, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

Scott & White Memorial Hospital

Temple, Texas, United States

Leipzig Heart Center

Leipzig, , Germany

Countries

United States; Germany

Other Identifiers

07071

Identifier Type: -

Identifier Source: org_study_id