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

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00819286
• Collaborator: (none)
• Enrollment: 140
• Locations: 6
• Arms: 2
• Duration (Months): 37
• Patients Per Site: 23.3
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sternal Wound Infection; Sternal Non-union; Pain; Mediastinitis	Device: SternaLock Rigid Fixation Plates; Device: wire (control)	N/A

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 Design

• Study Type: Interventional
• 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: Nov 1, 2008
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. CT Scan Evaluation of Sternal Bone Healing [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Heart and Lung Institute	Phoenix	Arizona	United States	85013
2	University of California Davis Medical Center	Sacramento	California	United States	95817
3	University of Chicago	Chicago	Illinois	United States	60637
4	Baptist Memorial Hospital	Memphis	Tennessee	United States	38120
5	Scott & White Memorial Hospital	Temple	Texas	United States	76508
6	Leipzig Heart Center	Leipzig		Germany

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT00819286
• Other Study ID Numbers: 07071
• First Posted: Jan 8, 2009
• Last Update Posted: Feb 13, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Zimmer Biomet: open heart surgery
• Additional relevant MeSH terms: Wound Infection; Mediastinitis

Study Results

Participant Flow

Recruitment Details	Prospective, randomized trial at 5 US sites and 1 European site. Patient enrollment occurred between November 2008 and May 2010.
Pre-assignment Detail	Patients were randomized at the time of sternal closure to either rigid plate fixation or wire cerclage. A total of 140 patients were enrolled in this study (70 in each treatment group) and included in an intent to treat analysis.

Arm/Group Title	Wire (Control)	Plates
Arm/Group Description	patients will have their sternum closed using stainless steel wires.	patients will have their sternum closed by rigid fixation using SternaLock plates.
Period Title: Overall Study
STARTED	70	70
COMPLETED	56	45
NOT COMPLETED	14	25

Baseline Characteristics

Arm/Group Title	Wire (Control)	Plates	Total
Arm/Group Description	patients will have their sternum closed using stainless steel wires.	patients will have their sternum closed by rigid fixation using SternaLock plates.	Total of all reporting groups
Overall Participants	70	70	140
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.0 (8.9)	66.3 (9.8)	65.2 (9.4)
Sex: Female, Male (Count of Participants)
Female	18 25.7%	19 27.1%	37 26.4%
Male	52 74.3%	51 72.9%	103 73.6%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients were randomized to receive a CT scan at either 3 or 6 months. All patients who received a CT scan were included in the analysis.

Arm/Group Title	Wire (Control)	Plates
Arm/Group Description	patients will have their sternum closed using stainless steel wires.	patients will have their sternum closed by rigid fixation using SternaLock plates.
Measure Participants	48	46
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 1

Statistical Analysis Overview	Comparison Group Selection	Wire (Control), Plates
	Comments	3 Month CT Scores (Plates vs Wires)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Wire (Control), Plates
	Comments	6 Month CT Scores (Plates vs Wires)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Activity Based Total Visual Analog Pain Score
Description	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

Outcome Measure Data

Analysis Population Description

All patients with VAS pain data at 6 months were included in the analysis of the primary endpoint Activity Based Total Visual Analog Pain Score.

Arm/Group Title	Wire (Control)	Plates
Arm/Group Description	patients will have their sternum closed using stainless steel wires.	patients will have their sternum closed by rigid fixation using SternaLock plates.
Measure Participants	56	44
Mean (Standard Deviation) [units on a scale]	7.28 (4.65)	7.20 (4.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Wire (Control), Plates
	Comments	Plates vs Wires
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.93
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	0 to 6 months
Adverse Event Reporting Description	Adverse events were classified for severity and causality
Arm/Group Title	Wire (Control)		Plates
Arm/Group Description	patients will have their sternum closed using stainless steel wires.		patients will have their sternum closed by rigid fixation using SternaLock plates.
All Cause Mortality
	Wire (Control)		Plates
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Wire (Control)		Plates
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/70 (34.3%)		32/70 (45.7%)
Blood and lymphatic system disorders
Anemia	1/70 (1.4%)	1	1/70 (1.4%)	1
Cardiac disorders
Cardiac arrest	2/70 (2.9%)	2	3/70 (4.3%)	4
Cardiac arrhythmias	2/70 (2.9%)	2	2/70 (2.9%)	2
Congestive heart failure	0/70 (0%)	0	1/70 (1.4%)	1
Low cardiac output	2/70 (2.9%)	2	0/70 (0%)	0
Multiple organ failure due to disecting aorta	1/70 (1.4%)	1	0/70 (0%)	0
Pacemaker implantation	0/70 (0%)	0	1/70 (1.4%)	1
Gastrointestinal disorders
GI Bleed	0/70 (0%)	0	2/70 (2.9%)	2
General disorders
Convulsion	1/70 (1.4%)	1	0/70 (0%)	0
Multi-organ failure	1/70 (1.4%)	1	0/70 (0%)	0
Infections and infestations
Cytomegalovirus colitis	0/70 (0%)	0	1/70 (1.4%)	1
Sepsis	0/70 (0%)	0	1/70 (1.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Suspicion of lung fibrosis; bronchitis ongoing	1/70 (1.4%)	1	0/70 (0%)	0
Nervous system disorders
Stroke	2/70 (2.9%)	3	1/70 (1.4%)	1
Renal and urinary disorders
Acute renal failure	2/70 (2.9%)	2	2/70 (2.9%)	2
Respiratory, thoracic and mediastinal disorders
Pleural effusion	1/70 (1.4%)	1	0/70 (0%)	0
Pneumonia	1/70 (1.4%)	1	1/70 (1.4%)	1
Respiratory failure	0/70 (0%)	0	3/70 (4.3%)	4
Respiratory insufficiency	3/70 (4.3%)	5	2/70 (2.9%)	2
Surgical and medical procedures
Resternotomy	7/70 (10%)	7	11/70 (15.7%)	11
Other (Not Including Serious) Adverse Events
	Wire (Control)		Plates
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/70 (28.6%)		24/70 (34.3%)
Cardiac disorders
Cardiac arrhythmias	9/70 (12.9%)	9	12/70 (17.1%)	12
Renal and urinary disorders
Acute renal failure	1/70 (1.4%)	1	4/70 (5.7%)	4
Respiratory, thoracic and mediastinal disorders
Pleural effusion	10/70 (14.3%)	10	8/70 (11.4%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Principal investigator may publish his/her own results from the study provided such publication does not include or disclose any confidential information. Principal investigator may also participate in joint publications. All proposed publications shall be submitted to Biomet for review. Biomet will have 30 days to review the proposed publication.