Clinical trial NCT00819286: Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
Official title: A Prospective, Randomized-Controlled, Multicenter Study Evaluating Primary Plating in High-Risk Median Sternotomy Patients for Osteosynthesis and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sternal Wound Infection
Sternal Non-union
Pain
Mediastinitis
Keywords: open heart surgery
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2009-01-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: CT Scan Evaluation of Sternal Bone Healing
timeFrame: 3 and 6 Months
measure: Activity Based Total Visual Analog Pain Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Heart and Lung Institute
state: Arizona
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Leipzig
country: Germany
facility: Leipzig Heart Center
Study officials:
affiliation: University of Chicago
name: Jai Raman, MD
role: STUDY_CHAIR
affiliation: University of California Davis Medical Center, Sacramento, CA
name: Michael Wong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph's Medical Center, Phoenix, AZ
name: Brian DeGuzmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Leipzig Heart Center, Leipzig, Germany
name: Sven Lehmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scott & White Memorial Hospital, Temple, TX
name: Kenton Zehr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Memorial Hospital, Memphis, TN
name: H Edward Garrett, Jr, MD
role: PRINCIPAL_INVESTIGATOR
References: