Trial Outcomes & Findings for Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain (NCT NCT00819286)
NCT ID: NCT00819286
Last Updated: 2018-02-13
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
3 and 6 Months
Results posted on
2018-02-13
Participant Flow
Prospective, randomized trial at 5 US sites and 1 European site. Patient enrollment occurred between November 2008 and May 2010.
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.
Participant milestones
| Measure |
Wire (Control)
patients will have their sternum closed using stainless steel wires.
|
Plates
patients will have their sternum closed by rigid fixation using SternaLock plates.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
56
|
45
|
|
Overall Study
NOT COMPLETED
|
14
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
Baseline characteristics by cohort
| Measure |
Wire (Control)
n=70 Participants
patients will have their sternum closed using stainless steel wires.
|
Plates
n=70 Participants
patients will have their sternum closed by rigid fixation using SternaLock plates.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
66.3 years
STANDARD_DEVIATION 9.8 • n=107 Participants
|
65.2 years
STANDARD_DEVIATION 9.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 and 6 MonthsPopulation: 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.
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)
Outcome measures
| Measure |
Wire (Control)
n=48 Participants
patients will have their sternum closed using stainless steel wires.
|
Plates
n=46 Participants
patients will have their sternum closed by rigid fixation using SternaLock plates.
|
|---|---|---|
|
CT Scan Evaluation of Sternal Bone Healing
3 Month CT Scan (n=25 wire, n=27 plates)
|
0.9 units on a scale
Standard Deviation 0.8
|
1.7 units on a scale
Standard Deviation 1.1
|
|
CT Scan Evaluation of Sternal Bone Healing
6 Month CT Scan (n=26 wire, n=23 plates)
|
2.2 units on a scale
Standard Deviation 1.1
|
3.2 units on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Wire (Control)
n=56 Participants
patients will have their sternum closed using stainless steel wires.
|
Plates
n=44 Participants
patients will have their sternum closed by rigid fixation using SternaLock plates.
|
|---|---|---|
|
Activity Based Total Visual Analog Pain Score
|
7.28 units on a scale
Standard Deviation 4.65
|
7.20 units on a scale
Standard Deviation 4.04
|
Adverse Events
Wire (Control)
Serious events: 24 serious events
Other events: 20 other events
Deaths: 0 deaths
Plates
Serious events: 32 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Wire (Control)
n=70 participants at risk
patients will have their sternum closed using stainless steel wires.
|
Plates
n=70 participants at risk
patients will have their sternum closed by rigid fixation using SternaLock plates.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Cardiac disorders
Cardiac arrest
|
2.9%
2/70 • Number of events 2 • 0 to 6 months
Adverse events were classified for severity and causality
|
4.3%
3/70 • Number of events 4 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Cardiac disorders
Cardiac arrhythmias
|
2.9%
2/70 • Number of events 2 • 0 to 6 months
Adverse events were classified for severity and causality
|
2.9%
2/70 • Number of events 2 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/70 • 0 to 6 months
Adverse events were classified for severity and causality
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Cardiac disorders
Low cardiac output
|
2.9%
2/70 • Number of events 2 • 0 to 6 months
Adverse events were classified for severity and causality
|
0.00%
0/70 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Cardiac disorders
Multiple organ failure due to disecting aorta
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
0.00%
0/70 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Cardiac disorders
Pacemaker implantation
|
0.00%
0/70 • 0 to 6 months
Adverse events were classified for severity and causality
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Gastrointestinal disorders
GI Bleed
|
0.00%
0/70 • 0 to 6 months
Adverse events were classified for severity and causality
|
2.9%
2/70 • Number of events 2 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
General disorders
Convulsion
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
0.00%
0/70 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/70 • 0 to 6 months
Adverse events were classified for severity and causality
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Infections and infestations
Sepsis
|
0.00%
0/70 • 0 to 6 months
Adverse events were classified for severity and causality
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
General disorders
Multi-organ failure
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
0.00%
0/70 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Suspicion of lung fibrosis; bronchitis ongoing
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
0.00%
0/70 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Nervous system disorders
Stroke
|
2.9%
2/70 • Number of events 3 • 0 to 6 months
Adverse events were classified for severity and causality
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Renal and urinary disorders
Acute renal failure
|
2.9%
2/70 • Number of events 2 • 0 to 6 months
Adverse events were classified for severity and causality
|
2.9%
2/70 • Number of events 2 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
0.00%
0/70 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/70 • 0 to 6 months
Adverse events were classified for severity and causality
|
4.3%
3/70 • Number of events 4 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
4.3%
3/70 • Number of events 5 • 0 to 6 months
Adverse events were classified for severity and causality
|
2.9%
2/70 • Number of events 2 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Surgical and medical procedures
Resternotomy
|
10.0%
7/70 • Number of events 7 • 0 to 6 months
Adverse events were classified for severity and causality
|
15.7%
11/70 • Number of events 11 • 0 to 6 months
Adverse events were classified for severity and causality
|
Other adverse events
| Measure |
Wire (Control)
n=70 participants at risk
patients will have their sternum closed using stainless steel wires.
|
Plates
n=70 participants at risk
patients will have their sternum closed by rigid fixation using SternaLock plates.
|
|---|---|---|
|
Cardiac disorders
Cardiac arrhythmias
|
12.9%
9/70 • Number of events 9 • 0 to 6 months
Adverse events were classified for severity and causality
|
17.1%
12/70 • Number of events 12 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Renal and urinary disorders
Acute renal failure
|
1.4%
1/70 • Number of events 1 • 0 to 6 months
Adverse events were classified for severity and causality
|
5.7%
4/70 • Number of events 4 • 0 to 6 months
Adverse events were classified for severity and causality
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
10/70 • Number of events 10 • 0 to 6 months
Adverse events were classified for severity and causality
|
11.4%
8/70 • Number of events 8 • 0 to 6 months
Adverse events were classified for severity and causality
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER