CompletedNCT00819286RESTOREUpdated Feb 13, 2018Results posted

Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain

An interventional study of SternaLock Rigid Fixation Plates and wire (control) in Sternal Wound Infection, Sternal Non-union and Pain, sponsored by Zimmer Biomet. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-13.

Sponsored by Zimmer Biomet · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 140
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Sternal Wound Infection
Sternal Non-union
Pain
Mediastinitis

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Keywords

open heart surgery

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 140 participants (actual)

Study arms

Active comparator
wire (control)
patients will have their sternum closed using wire (stainless steel surgical wire).
Device: wire (control)
Experimental
SternaLock Rigid Fixation Plates
patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates.
Device: SternaLock Rigid Fixation Plates

Interventions

DeviceSternaLock Rigid Fixation Plates
patients will have their sternum closed by rigid fixation using SternaLock Rigid Fixation Plates
Devicewire (control)
patients will have their sternum closed using wire (stainless steel surgical wire).

What researchers measure

Primary outcomes

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)
Time frame: 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.
Time frame: 6 months

Results

Posted Mar 15, 2012

Participant flow

Prospective, randomized trial at 5 US sites and 1 European site. Patient enrollment occurred between November 2008 and May 2010.

Participant flow — Overall Study
Milestone	Wire (Control)	Plates
Started	70	70
Completed	56	45
Not completed	14	25

Outcome measures

PrimaryCT 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)

Time frame:: 3 and 6 Months
Reported as:: Mean · units on a scale

CT Scan Evaluation of Sternal Bone Healing
units on a scale	Wire (Control)	Plates
3 Month CT Scan (n=25 wire, n=27 plates)	0.9 ± 0.8	1.7 ± 1.1
6 Month CT Scan (n=26 wire, n=23 plates)	2.2 ± 1.1	3.2 ± 1.6

Statistical analysis

Wire (Control) vs Plates · t-test, 2 sided · p = 0.003 · Mean difference (final values): 0
Wire (Control) vs Plates · t-test, 2 sided · p = 0.01

PrimaryActivity 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.

Time frame:: 6 months
Reported as:: Mean · units on a scale

Activity Based Total Visual Analog Pain Score
units on a scale	Wire (Control)	Plates
Activity Based Total Visual Analog Pain Score	7.28 ± 4.65	7.20 ± 4.04

Statistical analysis

Wire (Control) vs Plates · t-test, 1 sided · p = 0.93 · Mean difference (final values): 0

Adverse events

Collected over 0 to 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Wire (Control)	—	24/70 (34.3%)	20/70 (28.6%)
Plates	—	32/70 (45.7%)	24/70 (34.3%)

Most frequent serious events

Showing 10 of 20

Most frequent serious events
Event	Wire (Control)	Plates
ResternotomySurgical and medical procedures	7/70	11/70
Cardiac arrestCardiac disorders	2/70	3/70
Respiratory failureRespiratory, thoracic and mediastinal disorders	0/70	3/70
Respiratory insufficiencyRespiratory, thoracic and mediastinal disorders	3/70	2/70
Cardiac arrhythmiasCardiac disorders	2/70	2/70
Low cardiac outputCardiac disorders	2/70	0/70
GI BleedGastrointestinal disorders	0/70	2/70
StrokeNervous system disorders	2/70	1/70
Acute renal failureRenal and urinary disorders	2/70	2/70
AnemiaBlood and lymphatic system disorders	1/70	1/70

Most frequent other events

Most frequent other events
Event	Wire (Control)	Plates
Cardiac arrhythmiasCardiac disorders	9/70	12/70
Pleural effusionRespiratory, thoracic and mediastinal disorders	10/70	8/70
Acute renal failureRenal and urinary disorders	1/70	4/70

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Wire (Control)	Plates	Total
Mean	64.0 ± 8.9	66.3 ± 9.8	65.2 ± 9.4

Sex: Female, Male
Sex: Female, Male(Participants)	Wire (Control)	Plates	Total
Female	18	19	37
Male	52	51	103

Study locations

6 sites

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

Registry details

Key details

Study ID: NCT00819286
Lead sponsor: Zimmer Biomet
Responsible party: Sponsor
First posted: Jan 8, 2009
Start date: Nov 2008
Primary completion: Jan 2011
Completion: Dec 2011
Results posted: Mar 15, 2012
Last update: Feb 13, 2018

Study contacts

Jai Raman, MD

study chair · University of Chicago

Michael Wong, MD

principal investigator · University of California Davis Medical Center, Sacramento, CA

Brian DeGuzmann, MD

principal investigator · St. Joseph's Medical Center, Phoenix, AZ

Sven Lehmann, MD

principal investigator · Leipzig Heart Center, Leipzig, Germany

Kenton Zehr, MD

principal investigator · Scott & White Memorial Hospital, Temple, TX

H Edward Garrett, Jr, MD

principal investigator · Baptist Memorial Hospital, Memphis, TN

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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