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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00819286
First received: January 6, 2009
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Sternal Wound Infection
Sternal Non-union
Pain
Mediastinitis
Device: SternaLock Rigid Fixation System
Device: Wire (control)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized-Controlled, Multicenter Study Evaluating Primary Plating in High-Risk Median Sternotomy Patients for Osteosynthesis and Pain

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • CT Scan Evaluation of Sternal Bone Healing [ Time Frame: 3 and 6 Months ] [ Designated as safety issue: No ]
    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)

  • Activity Based Total Visual Analog Pain Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 140
Study Start Date: November 2008
Study Completion Date: December 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: wire (control)
patients will have their sternum closed using stainless steel wires.
Device: Wire (control)
patients will have their sternum closed using stainless steel wires.
Experimental: plates
patients will have their sternum closed by rigid fixation using SternaLock plates.
Device: SternaLock Rigid Fixation System
patients will have their sternum closed by rigid fixation using SternaLock 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819286

Locations
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
Germany
Leipzig Heart Center
Leipzig, Germany
Sponsors and Collaborators
Biomet, Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00819286     History of Changes
Other Study ID Numbers: 07071
Study First Received: January 6, 2009
Results First Received: December 27, 2011
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biomet, Inc.:
open heart surgery

Additional relevant MeSH terms:
Mediastinitis
Wound Infection
Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on April 21, 2014