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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00819286
Recruitment Status : Completed
First Posted : January 8, 2009
Results First Posted : March 15, 2012
Last Update Posted : February 13, 2018
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment Phase
Sternal Wound Infection Sternal Non-union Pain Mediastinitis Device: SternaLock Rigid Fixation Plates Device: wire (control) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participant blinded to treatment assignment until completion of study.
Primary Purpose: Treatment
Official Title: A Prospective, Randomized-Controlled, Multicenter Study Evaluating Primary Plating in High-Risk Median Sternotomy Patients for Osteosynthesis and Pain
Study Start Date : November 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Active Comparator: wire (control)
patients will have their sternum closed using wire (stainless steel surgical wire).
Device: wire (control)
patients will have their sternum closed using wire (stainless steel surgical wire).

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

Primary Outcome Measures :
  1. 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)

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00819286

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United States, Arizona
St. Joseph's Heart and Lung Institute
Phoenix, Arizona, United States, 85013
United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Tennessee
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
United States, Texas
Scott & White Memorial Hospital
Temple, Texas, United States, 76508
Leipzig Heart Center
Leipzig, Germany
Sponsors and Collaborators
Zimmer Biomet
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Study Chair: Jai Raman, MD University of Chicago
Principal Investigator: 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
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Responsible Party: Zimmer Biomet Identifier: NCT00819286    
Other Study ID Numbers: 07071
First Posted: January 8, 2009    Key Record Dates
Results First Posted: March 15, 2012
Last Update Posted: February 13, 2018
Last Verified: January 2018
Keywords provided by Zimmer Biomet:
open heart surgery
Additional relevant MeSH terms:
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Wound Infection
Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases