Trident® Tritanium™ Acetabular Shell Revision Study

• Sponsor: Stryker Orthopaedics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00535626
• Collaborator: (none)
• Enrollment: 241
• Locations: 15
• Arm: 1
• Duration (Months): 118
• Patients Per Site: 16.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty, Replacement, Hip	Device: Trident® Tritanium™ Acetabular Shell	N/A

Detailed Description

Total hip replacement is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. Clinical results for cementless acetabular components have demonstrated excellent long-term fixation of these devices. However, so called 'first generation' cementless acetabular components have not had similar success rates. In these cases the acetabular component is often revised due to loosening, wear or infection.

Revision hip arthroplasty also becomes a challenge as patients often present with severe bone loss and poor bone quality. This can lead to compromised initial stability, which in turn leads to lack of long-term fixation and failure. Acetabular revision with a cementless component has shown improved results over cemented fixation.

Radiographic evaluation of the Trident® Tritanium™ Acetabular Shell will provide valuable early to intermediate information that may help predict the long-term success of this new system.

It is the intention of this study to closely follow subjects that have undergone revision hip replacement with regard to implant survivorship, signs of radiographic loosening, subjects' function evaluated through Harris Hip Score and Lower Extremity Activity Scale, subject quality of life through SF-36 and adverse events.

The primary efficacy hypothesis is that the rate of revision or pending revision (as defined by radiographic parameters) due to instability or lack of fixation for the Trident® Tritanium™ Acetabular Shell will be less than 10% at 5 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 241 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Post-market, Non-randomized, Open Label, Multi-center Clinical Study of the Trident Tritanium Acetabular Shell
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Trident® Tritanium™ Acetabular Shell Trident® Tritanium™ Acetabular Shell used in revision total hip replacement	Device: Trident® Tritanium™ Acetabular Shell; Trident® Tritanium™ Acetabular Shell

Outcome Measures

Primary Outcome Measures

1. Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation [5 years post-operative]

Secondary Outcome Measures

1. Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits [pre-op, 3 month, 1, 2, 3, 4, 5 years]

   The change in HHS is reported by comparing the mean pre-operative, 3-month, 1, 2, 3, 4, and 5 year post-operative scores. Scores can range from 0 to 100, with 0 being the worst and 100 being the best score. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.

2. Change in SF-36 From Pre-operative to Post-operative Visits [pre-op, 3 month, 1, 2, 3, 4, 5 years]

   The change in SF-36 is reported by comparing the mean preoperative, 3 month, 1, 2, 3, 4, and 5 year scores. The SF-36 Health Survey is a 36 item patient-completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.

3. Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones [3 month, 1, 2, 3, 4, 5 years]

   Defined as a lucent area seen parallel and in close proximity to the device at the prosthesis/bone interface encompassing at least 50% of the zone, and at least 1 mm or greater in width. May be accompanied by a radiopaque (reactive) line. Assessed for each of the three modified DeLee Charnley zones.

4. Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction [3 month, 1, 2, 3, 4, 5 years]

   Defined as the measurable change in the acetabular shell position relative to reproducible bony landmarks.

5. Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative [pre-op, 3 month, 1, 2, 3, 4, 5 years]

   The change in LEAS is reported by comparing the mean pre-operative, 3 month, 1, 2, 3, 4, and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Males and non-pregnant females, 21-85 years of age at the time of surgery.

2. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.

3. Patient has signed an IRB approved study consent form.

4. Patient is willing and able to comply with postoperative requirements including postoperative weight bearing restrictions and self-evaluations.

Exclusion Criteria:

1. Patient is morbidly obese, BMI > 40.

2. Patient has a systemic or metabolic bone disorder leading to progressive bone deterioration.

3. Patient is immunologically compromised or receiving steroids in excess of normal physiological requirements (> 30 days).

4. Patient's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.

5. Patient has an active or suspected latent infection on or about the hip joint.

6. Patient is a prisoner.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orthopedic Specialty Institute	Orange	California	United States	92868
2	Heekin Institute for Orthopedic Research, Inc.	Jacksonville	Florida	United States	32204
3	Cedars Medical Center	Miami	Florida	United States	33136
4	Illinois Bone & Joint Institute	Glenview	Illinois	United States	60025
5	University of Louisville, 201 Abraham Flexner Way, Suite 100	Louisville	Kentucky	United States	40202
6	New England Baptist Hospital	Boston	Massachusetts	United States	02120
7	St Joseph Mercy Hospital	Ypsilanti	Michigan	United States	48197
8	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
9	NYU Hospital for Joint Diseases	New York	New York	United States	10003
10	Hospital for Special Surgery	New York	New York	United States	10021
11	Crystal Clinic	Akron	Ohio	United States	44333
12	Cleveland Clinic	Cleveland	Ohio	United States	44195
13	The Methodist Hospital	Houston	Texas	United States	77030
14	Scott & White Memorial Hospital	Temple	Texas	United States	76508
15	Rockwood Clinic	Spokane	Washington	United States	99202

Sponsors and Collaborators

• Stryker Orthopaedics

Investigators

• Study Chair: Arthur Malkani, MD, University of Louisville
• Principal Investigator: Michael Masini, MD, St Joseph Mercy Hospital
• Principal Investigator: Daniel Ward, MD, New England Baptist Hospital
• Principal Investigator: Benjamin Bierbaum, MD, New England Baptist Hospital
• Principal Investigator: Kirby Hitt, MD, Scott & White Memorial Hospital
• Principal Investigator: Kenneth Greene, MD, Crystal Clinic
• Principal Investigator: Jim Kudrna, MD, Illinois Bone & Joint Institute
• Principal Investigator: Ivan Tomek, MD, Dartmouth-Hitchcock Medical Center
• Principal Investigator: Stephen Kantor, MD, Dartmouth-Hitchcock Medical Center
• Principal Investigator: Steven Barnett, MD, Orthopedic Specialty Institute
• Principal Investigator: Carlos Higuera, MD, The Cleveland Clinic
• Principal Investigator: Joseph Zuckerman, MD, NYU Hospital for Joint Diseases
• Principal Investigator: Fredrick Jaffe, MD, NYU Hospital for Joint Diseases
• Principal Investigator: Stephen Incavo, MD, The Methodist Hospital Research Institute
• Principal Investigator: Timothy Lovell, MD, Rockwood Clinic
• Principal Investigator: Sean Scully, MD, Cedars Medical Center
• Principal Investigator: Amar Ranawat, MD, Hospital for Special Surgery, New York
• Principal Investigator: Geoffrey Westrich, MD, Hospital for Special Surgery, New York
• Principal Investigator: R D Heekin, MD, Heekin Institute for Orthopedic Research, Inc.
• Principal Investigator: Bryce Allen, MD, Scott & White Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stryker Orthopaedics
• ClinicalTrials.gov Identifier: NCT00535626
• Other Study ID Numbers: 61
• First Posted: Sep 26, 2007
• Last Update Posted: Nov 20, 2017
• Last Verified: Nov 1, 2017

Study Results

Participant Flow

Pre-assignment Detail	241 patients/245 hips - 51 patients/52 hips censored = 190 patients/193 hips followed

Arm/Group Title	Trident® Tritanium™ Acetabular Shell
Arm/Group Description	Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Period Title: Overall Study
STARTED	190
COMPLETED	85
NOT COMPLETED	105

Baseline Characteristics

Arm/Group Title	Trident® Tritanium™ Acetabular Shell
Arm/Group Description	Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Overall Participants	190
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.70 (11.45)
Sex: Female, Male (Count of Participants)
Female	85 44.7%
Male	105 55.3%
Region of Enrollment (Count of Participants)
United States	190 100%

Outcome Measures

1. Primary Outcome

Title	Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation
Time Frame	5 years post-operative

Outcome Measure Data

Analysis Population Description

No cases were pending revision.

Arm/Group Title	Trident® Tritanium™ Acetabular Shell
Arm/Group Description	Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Measure Participants	190
Measure hips	193
Count of Units [hips]	4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trident® Tritanium™ Acetabular Shell
	Comments
	Type of Statistical Test	Other
	Comments	To test if revision rate at 5 years is less than 10% (Ha - Alternative Hypothesis). Note: All cases enrolled in the study had to undergo revision whether from their primary procedure or a previous revision. Based on literature, 10% is the expected rate of another revision occurring in this cohort of enrolled patients.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Revision or Pending Revision Rate
	Estimated Value	2.43
	Confidence Interval	(2-Sided) 90%; 1.07 to 5.46
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated 2.43% revision rate was obtained by the Kaplan-Meier method.

2. Secondary Outcome

Title	Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits
Description	The change in HHS is reported by comparing the mean pre-operative, 3-month, 1, 2, 3, 4, and 5 year post-operative scores. Scores can range from 0 to 100, with 0 being the worst and 100 being the best score. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.
Time Frame	pre-op, 3 month, 1, 2, 3, 4, 5 years

Outcome Measure Data

Analysis Population Description

Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.

Arm/Group Title	Trident® Tritanium™ Acetabular Shell
Arm/Group Description	Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Measure Participants	171
Measure hips	173
Mean HHS score preoperative	53.40 (21.99)
Mean HHS score 3 months	79.46 (16.58)
Mean HHS score 1 year	86.11 (14.83)
Mean HHS score 2 years	85.34 (15.60)
Mean HHS score 3 years	86.56 (15.40)
Mean HHS score 4 years	83.87 (17.32)
Mean HHS score 5 years	86.29 (14.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trident® Tritanium™ Acetabular Shell
	Comments
	Type of Statistical Test	Other
	Comments	To test if the change from the pre-operative HHS compared to the post-operative HHS at all intervals is statistically significant.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	This p-value applies to all intervals.
	Method	t-test, 2 sided
	Comments	Paired t-test

3. Secondary Outcome

Title	Change in SF-36 From Pre-operative to Post-operative Visits
Description	The change in SF-36 is reported by comparing the mean preoperative, 3 month, 1, 2, 3, 4, and 5 year scores. The SF-36 Health Survey is a 36 item patient-completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Time Frame	pre-op, 3 month, 1, 2, 3, 4, 5 years

Outcome Measure Data

Analysis Population Description

Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.

Arm/Group Title	Trident® Tritanium™ Acetabular Shell
Arm/Group Description	Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Measure Participants	181
Measure hips	184
Physical score preoperative	33.26 (10.36)
Physical score 3 months	38.9 (10.7)
Physical score 1 year	43.04 (10.31)
Physical score 2 years	43.55 (10.7)
Physical score 3 years	43.54 (10.29)
Physical score 4 years	42.76 (11.27)
Physical score 5 years	43.82 (11.4)
Mental score preoperative	49.56 (13.08)
Mental score 3 months	52.07 (11.4)
Mental score 1 year	52.81 (10.44)
Mental score 2 years	53.37 (10.22)
Mental score 3 years	53.84 (9.67)
Mental score 4 years	53.63 (10.29)
Mental score 5 years	52.93 (9.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trident® Tritanium™ Acetabular Shell
	Comments
	Type of Statistical Test	Other
	Comments	To test whether the change from the pre-operative SF-36 Physical Score compared to each post-operative SF-36 Physical score is statistically significant.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	This p-value applies to all intervals.
	Method	t-test, 2 sided
	Comments	Paired t-test

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Trident® Tritanium™ Acetabular Shell
	Comments
	Type of Statistical Test	Other
	Comments	To test whether the change from the pre-operative SF-36 Mental Score compared to the 3 month SF-36 Mental Score is statistically significant.
Statistical Test of Hypothesis	p-Value	0.0139
	Comments
	Method	t-test, 2 sided
	Comments	Paired t-test

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Trident® Tritanium™ Acetabular Shell
	Comments
	Type of Statistical Test	Other
	Comments	To test whether the change from the pre-operative SF-36 Mental Score compared to the 1 year SF-36 Mental Score is statistically significant.
Statistical Test of Hypothesis	p-Value	0.0254
	Comments
	Method	t-test, 2 sided
	Comments	Paired t-test

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Trident® Tritanium™ Acetabular Shell
	Comments
	Type of Statistical Test	Other
	Comments	To test whether the change from the SF-36 Mental Score compared to the 2 year SF-36 Mental Score is statistically significant.
Statistical Test of Hypothesis	p-Value	0.1506
	Comments
	Method	t-test, 2 sided
	Comments	Paired t-test

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Trident® Tritanium™ Acetabular Shell
	Comments
	Type of Statistical Test	Other
	Comments	To test whether the change from the pre-operative SF-36 Mental Score compared to the 3 year SF-36 Mental Score is statistically significant.
Statistical Test of Hypothesis	p-Value	0.0936
	Comments
	Method	t-test, 2 sided
	Comments	Paired t-test

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Trident® Tritanium™ Acetabular Shell
	Comments
	Type of Statistical Test	Other
	Comments	To test if the change from the pre-operative SF-36 Mental Score compared to the 4 year SF-36 Mental Score is statistically significant.
Statistical Test of Hypothesis	p-Value	0.0909
	Comments
	Method	t-test, 2 sided
	Comments	Paired t-test

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Trident® Tritanium™ Acetabular Shell
	Comments
	Type of Statistical Test	Other
	Comments	To test whether the change from the pre-operative SF-36 Mental Score compared to the 5 year SF-36 Mental Score is statistically significant.
Statistical Test of Hypothesis	p-Value	0.048
	Comments
	Method	t-test, 2 sided
	Comments	Paired t-test

4. Secondary Outcome

Title	Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones
Description	Defined as a lucent area seen parallel and in close proximity to the device at the prosthesis/bone interface encompassing at least 50% of the zone, and at least 1 mm or greater in width. May be accompanied by a radiopaque (reactive) line. Assessed for each of the three modified DeLee Charnley zones.
Time Frame	3 month, 1, 2, 3, 4, 5 years

Outcome Measure Data

Analysis Population Description

Participants/hips are based on evaluable films for this data point. Overall number of participants and hips analyzed is based upon the 3 month population.

Arm/Group Title	Trident® Tritanium™ Acetabular Shell
Arm/Group Description	Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Measure Participants	152
Measure hips	154
RLL> 2mm in all zones at 3 months	3
RLL> 2mm in all zones at 1 year	0
RLL> 2mm in all zones at 2 years	0
RLL> 2mm in all zones at 3 years	0
RLL> 2mm in all zones at 4 years	0
RLL> 2mm in all zones at 5 years	0

5. Secondary Outcome

Title	Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction
Description	Defined as the measurable change in the acetabular shell position relative to reproducible bony landmarks.
Time Frame	3 month, 1, 2, 3, 4, 5 years

Outcome Measure Data

Analysis Population Description

Participants/hips are based on evaluable films for this data point. Overall number of participants and hips is based upon the 3 month population.

Arm/Group Title	Trident® Tritanium™ Acetabular Shell
Arm/Group Description	Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Measure Participants	156
Measure hips	158
Migration >5mm at 3 months	0
Migration >5mm at 1 year	0
Migration >5mm at 2 years	0
Migration >5mm at 3 years	0
Migration >5mm at 4 years	0
Migration >5mm at 5 years	0

6. Secondary Outcome

Title	Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative
Description	The change in LEAS is reported by comparing the mean pre-operative, 3 month, 1, 2, 3, 4, and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Time Frame	pre-op, 3 month, 1, 2, 3, 4, 5 years

Outcome Measure Data

Analysis Population Description

Participants/hips with available data. Overall number of participants and hips analysed is based upon the preoperative population.

Arm/Group Title	Trident® Tritanium™ Acetabular Shell
Arm/Group Description	Trident® Tritanium™ Acetabular Shell used in revision total hip replacement
Measure Participants	186
Measure hips	189
LEAS preoperative	8.32 (3.27)
LEAS 3 month	9.25 (2.74)
LEAS 1 year	10.5 (2.95)
LEAS 2 years	10.37 (3.25)
LEAS 3 years	10.6 (3.26)
LEAS 4 years	10.25 (3.18)
LEAS 5 years	10.15 (3.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trident® Tritanium™ Acetabular Shell
	Comments
	Type of Statistical Test	Other
	Comments	To test whether the change from the pre-operative LEAS Score compared to the 3 month LEAS Score is statistically significant.
Statistical Test of Hypothesis	p-Value	0.0011
	Comments
	Method	t-test, 2 sided
	Comments	Paired t-test

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Trident® Tritanium™ Acetabular Shell
	Comments
	Type of Statistical Test	Other
	Comments	To test whether the change from the pre-operative LEAS compared to the 1, 2 and 3 year LEAS are statistically significant.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	This p-value applies to pre-op to 1, 2 and 3 year intervals.
	Method	t-test, 2 sided
	Comments	Paired t-test

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Trident® Tritanium™ Acetabular Shell
	Comments
	Type of Statistical Test	Other
	Comments	To test whether the change from the pre-operative LEAS compared to the 4 year LEAS is statistically significant.
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	t-test, 2 sided
	Comments	Paired t-test

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Trident® Tritanium™ Acetabular Shell
	Comments
	Type of Statistical Test	Other
	Comments	To test whether the change from the pre-operative LEAS compared to the 5 year LEAS is statistically significant.
Statistical Test of Hypothesis	p-Value	0.0009
	Comments
	Method	t-test, 2 sided
	Comments	Paired t-test

Adverse Events

Time Frame	Reportable adverse events for this study include those that are serious or related to the device.
Adverse Event Reporting Description	Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular & bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, & mid-foot/flat-foot surgery.
Arm/Group Title	Operative Site Events		Non-operative Site Events
Arm/Group Description	Trident® Tritanium™ Acetabular Shell used in revision total hip replacement. Operative site events are reported by hip.		Trident® Tritanium™ Acetabular Shell used in revision total hip replacement. Non-Operative site events are reported by participant.
All Cause Mortality
	Operative Site Events		Non-operative Site Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Operative Site Events		Non-operative Site Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/193 (14.5%)		41/190 (21.6%)
Cardiac disorders
Non-operative site	0/0 (NaN)	0	10/190 (5.3%)	11
Gastrointestinal disorders
Non-operative site	0/0 (NaN)	0	2/190 (1.1%)	3
General disorders
Non-operative site	0/0 (NaN)	0	6/190 (3.2%)	6
Hepatobiliary disorders
Non-operative site	0/0 (NaN)	0	1/190 (0.5%)	1
Infections and infestations
Operative site	9/193 (4.7%)	10	0/0 (NaN)	0
Non-operative site	0/0 (NaN)	0	9/190 (4.7%)	9
Metabolism and nutrition disorders
Non-operative site	0/0 (NaN)	0	2/190 (1.1%)	2
Musculoskeletal and connective tissue disorders
Operative site	18/193 (9.3%)	19	0/0 (NaN)	0
Non-operative site	0/0 (NaN)	0	10/190 (5.3%)	10
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-operative site	0/0 (NaN)	0	5/190 (2.6%)	7
Nervous system disorders
Non-operative site	0/0 (NaN)	0	1/190 (0.5%)	1
Renal and urinary disorders
Non-operative site	0/0 (NaN)	0	2/190 (1.1%)	2
Respiratory, thoracic and mediastinal disorders
Non-operative site	0/0 (NaN)	0	2/190 (1.1%)	2
Vascular disorders
Non-operative site	0/0 (NaN)	0	5/190 (2.6%)	5
Operative site	1/193 (0.5%)	1	0/0 (NaN)	0
Other (Not Including Serious) Adverse Events
	Operative Site Events		Non-operative Site Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/193 (0%)		0/190 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Each investigator shall have privileges for their own center's results at the completion of the study.These manuscripts & abstracts will be delayed until after the multi-center publication is submitted.All publications shall be submitted to the sponsor for review at least 60 days prior to the submission for publication.The sponsor shall not edit or otherwise influence the publications other than to ensure that confidential information is not disclosed and that the data is accurately represented.