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

Primary Purpose

Sternal Wound Infection, Sternal Non-union, Pain

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

SternaLock Rigid Fixation Plates

wire (control)

About this trial

This is an interventional treatment trial for Sternal Wound Infection focused on measuring open heart surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

St. Joseph's Heart and Lung Institute
University of California Davis Medical Center
University of Chicago
Baptist Memorial Hospital
Scott & White Memorial Hospital
Leipzig Heart Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

wire (control)

SternaLock Rigid Fixation Plates

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00819286

First Posted

January 6, 2009

Last Updated

January 16, 2018

Sponsor

Zimmer Biomet

1. Study Identification

Unique Protocol Identification Number

NCT00819286

Brief Title

Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain

Acronym

RESTORE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zimmer Biomet

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

open heart surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Masking Description

Participant blinded to treatment assignment until completion of study.

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

wire (control)

Arm Type

Active Comparator

Arm Description

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

Arm Title

SternaLock Rigid Fixation Plates

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

SternaLock Rigid Fixation Plates

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

wire (control)

Intervention Description

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

Primary Outcome Measure Information:

Title

CT Scan Evaluation of Sternal Bone Healing

Description

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)

Time Frame

3 and 6 Months

Title

Activity Based Total Visual Analog Pain Score

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: