Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain

NCT00819286 | Completed Results

• 1 other identifier: 07071
• Study Type: interventional
• Target: 140
• Locations: 2 countries
• Sites: 6

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.

Conditions

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

Keywords

open heart surgery

Outcome Measures

Primary Outcomes (2)

• CT Scan Evaluation of Sternal Bone Healing

  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)

  3 and 6 Months

• Activity Based Total Visual Analog Pain Score

  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.

  6 months

Study Arms (2)

wire (control)

ACTIVE COMPARATOR

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

Device: wire (control)

SternaLock Rigid Fixation Plates

EXPERIMENTAL

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

Device: SternaLock Rigid Fixation Plates

Interventions

SternaLock Rigid Fixation Plates DEVICE

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

SternaLock Rigid Fixation Plates

wire (control) DEVICE

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

wire (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (6)

St. Joseph's Heart and Lung Institute

Phoenix, Arizona, 85013, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Leipzig Heart Center

Leipzig, Germany

Location

MeSH Terms

Conditions

Pain; Mediastinitis

Interventions

Bone Wires

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Results Point of Contact

• Title: Brian Hatcher
• Organization: Biomet Microfixation

brian.hatcher@biomet.com

904-741-4400

Study Officials

• Jai Raman, MD

  University of Chicago

  STUDY CHAIR

• Michael Wong, MD

  University of California Davis Medical Center, Sacramento, CA

  PRINCIPAL INVESTIGATOR

• Brian DeGuzmann, MD

  St. Joseph's Medical Center, Phoenix, AZ

  PRINCIPAL INVESTIGATOR

• Sven Lehmann, MD

  Leipzig Heart Center, Leipzig, Germany

  PRINCIPAL INVESTIGATOR

• Kenton Zehr, MD

  Scott & White Memorial Hospital, Temple, TX

  PRINCIPAL INVESTIGATOR

• H Edward Garrett, Jr, MD

  Baptist Memorial Hospital, Memphis, TN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant blinded to treatment assignment until completion of study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 8, 2009
• Study Start: November 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 13, 2018
• Results First Posted: March 15, 2012

Record last verified: 2018-01

Locations

US (5); DE (1)