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

January 16, 2018 updated by: Zimmer Biomet

A Prospective, Randomized-Controlled, Multicenter Study Evaluating Primary Plating in High-Risk Median Sternotomy Patients for Osteosynthesis and Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany
        • Leipzig Heart Center
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Heart and Lung Institute
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital
    • Texas
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 and 6 Months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

January 6, 2009

First Submitted That Met QC Criteria

January 7, 2009

First Posted (ESTIMATE)

January 8, 2009

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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