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Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study

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ClinicalTrials.gov Identifier: NCT00957723
Recruitment Status : Completed
First Posted : August 12, 2009
Results First Posted : April 8, 2014
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Arthroplasty, Replacement, Knee
Intervention Device: Triathlon® CR Total Knee System
Enrollment 419
Recruitment Details  
Pre-assignment Details 467/500 participants/knees enrolled;56 participants/60 knees censored = 411/440 participants/knees followed
Arm/Group Title Triathlon® CR Total Knee System
Hide Arm/Group Description Participants who received the Triathlon® CR Total Knee System can have one or both knees replaced. If both knees were replaced, but only one knee completed the study, the participant is counted as having completed.
Period Title: Overall Study
Started 411
Completed 298 [1]
Not Completed 113
Reason Not Completed
Death             3
Revision/ Removal of Study Implant             3
Lost to Follow-up             8
Withdrawal by Subject             24
Investigative Site Terminated             61
Intercurrent Illness             2
2yr ROM Data Not Evaluable             12
[1]
Completed/Not completed counts are based on participant status at the 2yr primary outcome interval.
Arm/Group Title Triathlon® CR Total Knee System
Hide Arm/Group Description Participants who received the Triathlon® CR Total Knee System and were not censored from analysis.
Overall Number of Baseline Participants 411
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 411 participants
65.5  (8.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 411 participants
Female
239
  58.2%
Male
172
  41.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 411 participants
411
1.Primary Outcome
Title Active Range of Motion
Hide Description [Not Specified]
Time Frame 2 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants/knees with available data.
Arm/Group Title Triathlon® CR Total Knee System
Hide Arm/Group Description:
Non-censored participants/knees who received the Triathlon® CR Total Knee System
Overall Number of Participants Analyzed 298
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
317
Mean (Standard Deviation)
Unit of Measure: Degrees
119.2  (10.66)
2.Secondary Outcome
Title Change in Knee Society Score (KSS) Over Time
Hide Description The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as “excellent,” “good,” “fair,” or “poor,” a higher value represents a better outcome.
Time Frame preoperative, 1, 2, and 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population.
Arm/Group Title Triathlon® CR Total Knee System
Hide Arm/Group Description:
Non-censored participants/knees who received the Triathlon® CR Total Knee System
Overall Number of Participants Analyzed 410
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
439
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pain/Motion Mean Preoperative Score Number Analyzed 414 knees [1] 
37.39  (13.80)
Pain/Motion Mean 1 Year Score Number Analyzed 364 knees [2] 
92.12  (10.13)
Pain/Motion Mean 2 Year Score Number Analyzed 298 knees [3] 
93.83  (7.93)
Pain/Motion Mean 5 Year Score Number Analyzed 190 knees [4] 
94.86  (8.48)
Function Mean Preoperative Score Number Analyzed 439 knees
53.34  (17.46)
Function Mean 1 Year Score Number Analyzed 385 knees [5] 
86.04  (17.40)
Function Mean 2 Year Score Number Analyzed 309 knees [6] 
86.08  (17.98)
Function Mean 5 Year Score Number Analyzed 203 knees [7] 
85.49  (19.62)
[1]
387 participants
[2]
340 participants
[3]
280 participants
[4]
185 participants
[5]
359 participants
[6]
290 participants
[7]
198 participants
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triathlon® CR Total Knee System
Comments Change from pre-op to 1 year, 2 year and 5 year
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
3.Secondary Outcome
Title Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM)
Hide Description Knee range of motion is measured by the number of degrees flexion and extension observed. Active motion is the number of degrees that a participant can extend and flex their knee independently. Passive motion is the number of degrees that an examiner is able to extend and flex the knee without the assistance of the participant. The Knee Society Score range of motion utilized for this study defines the range from 0 degrees of extension to 125 degrees of flexion.
Time Frame 1, 2, and 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants/knees with available data. Overall number of participants and units analyzed is based upon preoperative population.
Arm/Group Title Triathlon® CR Total Knee System
Hide Arm/Group Description:
Non-censored participants/knees who received the Triathlon® CR Total Knee System
Overall Number of Participants Analyzed 360
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
386
Mean (Standard Deviation)
Unit of Measure: degrees
Active Flexion 1 Year Number Analyzed 386 knees
118.47  (10.59)
Active Flexion 2 Years Number Analyzed 317 knees [1] 
119.53  (10.26)
Active Flexion 5 Years Number Analyzed 201 knees [2] 
120.74  (9.00)
Active Extension 1 Year Number Analyzed 386 knees
0.37  (1.66)
Active Extension 2 Years Number Analyzed 317 knees [1] 
0.28  (1.71)
Active Extension 5 Years Number Analyzed 201 knees [2] 
0.26  (1.49)
Passive Flexion 1 Year Number Analyzed 385 knees [3] 
121.55  (10.43)
Passive Flexion 2 Years Number Analyzed 312 knees [4] 
122.89  (10.39)
Passive Flexion 5 Years Number Analyzed 197 knees [5] 
123.41  (8.53)
Passive Extension 1 Year Number Analyzed 385 knees [3] 
0.19  (1.23)
Passive Extension 2 Years Number Analyzed 312 knees [4] 
0.08  (0.91)
Passive Extension 5 Years Number Analyzed 197 knees [5] 
0.16  (1.01)
[1]
298 participants
[2]
196 participants
[3]
359 participants
[4]
293 participants
[5]
192 participants
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triathlon® CR Total Knee System
Comments Change from pre-op to 1, 2, and 5 year
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
4.Secondary Outcome
Title Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score
Hide Description Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths in millimeters are added for each zone for each of the three prostheses. The total produces a numerical score for each component. Failure is defined as a score of 10 or greater, regardless of symptoms.
Time Frame 1, 2, and 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants/knees with available data. Overall number of participants and units analyzed is based upon the one year population.
Arm/Group Title Triathlon® CR Total Knee System
Hide Arm/Group Description:
Non-censored participants/knees who received the Triathlon® CR Total Knee System
Overall Number of Participants Analyzed 347
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
370
Measure Type: Number
Unit of Measure: Total number of knees
Radiographic Failure at 1 Year Number Analyzed 370 knees
1
Radiographic Failure at 2 Years Number Analyzed 314 knees [1] 
1
Radiographic Failure at 5 Years Number Analyzed 203 knees [2] 
0
[1]
295 participants
[2]
198 participants
5.Secondary Outcome
Title Change in SF-36 Health Survey Over Time
Hide Description 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 preoperative, 1, 2, 3, 4, and 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population.
Arm/Group Title Triathlon® CR Total Knee System
Hide Arm/Group Description:
Non-censored participants/knees who received the Triathlon® CR Total Knee System
Overall Number of Participants Analyzed 403
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
432
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Score Preoperative Number Analyzed 432 knees
32.54  (7.50)
Physical Score 1 Year Number Analyzed 379 knees [1] 
47.77  (7.96)
Physical Score 2 Years Number Analyzed 303 knees [2] 
47.48  (8.71)
Physical Score 3 Years Number Analyzed 270 knees [3] 
46.94  (9.06)
Physical Score 4 Years Number Analyzed 223 knees [4] 
46.22  (9.46)
Physical score 5 Years Number Analyzed 195 knees [5] 
46.04  (9.57)
Mental Score Preoperative Number Analyzed 432 knees
52.55  (12.13)
Mental Score 1 Year Number Analyzed 379 knees [1] 
55.60  (7.79)
Mental Score 2 Years Number Analyzed 303 knees [2] 
55.79  (7.86)
Mental Score 3 Years Number Analyzed 270 knees [3] 
55.53  (7.72)
Mental Score 4 Years Number Analyzed 223 knees [4] 
54.72  (7.87)
Mental Score 5 Years Number Analyzed 195 knees [5] 
55.65  (8.37)
[1]
356 participants
[2]
284 participants
[3]
258 participants
[4]
219 participants
[5]
190 participants
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triathlon® CR Total Knee System
Comments SF36 Physical Component Score change from preop to 1 year
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Triathlon® CR Total Knee System
Comments SF36 Mental Component Score change from preop to 1 year
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Triathlon® CR Total Knee System
Comments SF36 Physical Component Score change from preop to 2 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Triathlon® CR Total Knee System
Comments SF36 Mental Component Score change from preop to 2 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0177
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Triathlon® CR Total Knee System
Comments SF36 Physical Component Score change from preop to 3 year
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Triathlon® CR Total Knee System
Comments SF36 Mental Component Score change from preop to 3 year
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0393
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Triathlon® CR Total Knee System
Comments SF36 Physical Component Score change from preop to 4 year
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Triathlon® CR Total Knee System
Comments SF36 Mental Component Score change from preop to 4 year
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4905
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Triathlon® CR Total Knee System
Comments SF36 Physical Component Score change from preop to 5 year
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Triathlon® CR Total Knee System
Comments SF36 Mental Component Score change from preop to 5 year
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0037
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
6.Secondary Outcome
Title Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time
Hide Description The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.
Time Frame preoperative,1, 2, 3, 4 and 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants/knees with available data. Data for the WOMAC is only available at the 2, 3, 4 and 5 year intervals in limited numbers due to typographical errors noted on earlier interval forms rendering them invalid for comparison.
Arm/Group Title Triathlon® CR Total Knee System
Hide Arm/Group Description:
Non-censored participants/knees who received the Triathlon® CR Total Knee System
Overall Number of Participants Analyzed 94
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
97
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total WOMAC 2 Years Number Analyzed 1 knees [1] 
94.54
Total WOMAC 3 Years Number Analyzed 1 knees [1] 
11.68
Total WOMAC 4 Years Number Analyzed 51 knees [2] 
36.33  (48.92)
Total WOMAC 5 Years Number Analyzed 97 knees
26.71  (36.18)
[1]
1 participants
[2]
50 participants
7.Secondary Outcome
Title Change in Lower-Extremity Activity Scale (LEAS) Over Time
Hide Description 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 preoperative, 1, 2, 3, 4, and 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population.
Arm/Group Title Triathlon® CR Total Knee System
Hide Arm/Group Description:
Non-censored participants/knees who received the Triathlon® CR Total Knee System
Overall Number of Participants Analyzed 409
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
438
Mean (Standard Deviation)
Unit of Measure: units on a scale
LEAS Preoperative Number Analyzed 438 knees
9.30  (2.87)
LEAS 1 Year Number Analyzed 380 knees [1] 
11.22  (2.71)
LEAS 2 Years Number Analyzed 304 knees [2] 
11.45  (2.91)
LEAS 3 Years Number Analyzed 273 knees [3] 
11.10  (2.76)
LEAS 4 Years Number Analyzed 222 knees [4] 
11.10  (2.89)
LEAS 5 Years Number Analyzed 201 knees [5] 
11.44  (2.94)
[1]
356 participants
[2]
286 participants
[3]
261 participants
[4]
218 participants
[5]
196 participants
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triathlon® CR Total Knee System
Comments LEAS score change from preop to 1, 2, 3, 4, and 5 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
8.Secondary Outcome
Title Patellar Subluxation, Dislocation and Fracture Rate
Hide Description The incidence of patellar subluxation, dislocation or fracture is reported.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants/knees with available data at 5 years.
Arm/Group Title Triathlon® CR Total Knee System
Hide Arm/Group Description:
Non-censored participants/knees who received the Triathlon® CR Total Knee System
Overall Number of Participants Analyzed 210
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
215
Count of Units
Unit of Measure: knees
Patellar fracture
4
   1.9%
Patellar subluxation
0
   0.0%
Patellar dislocation
0
   0.0%
9.Secondary Outcome
Title Patient Outcome Long Term Follow-up Questionnaire Over Time
Hide Description

Patient-reported outcome is collected using a long-term follow-up questionnaire at 6, 7, 8, 9, and 10 years postoperative for the subjects who consent to participation in the long-term follow-up study. The questionnaire consists of three yes or no questions:

  1. Do you have any pain in your knee that has the study knee replacement?
  2. Are you satisfied with the results of your study total knee replacement?
  3. Have you had any surgery on your study knee since the time of your last study required visit/contact?
Time Frame 6, 7, 8, 9, and 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants/knees with available data. Overall number of participants and units analyzed is based upon the eight year postoperative population, as this was the largest available population between the 6-10 year postoperative intervals.
Arm/Group Title Triathlon® CR Total Knee System
Hide Arm/Group Description:
Non-censored participants/knees who received the Triathlon® CR Total Knee System, and consented to the long-term follow-up study.
Overall Number of Participants Analyzed 93
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
93
Count of Units
Unit of Measure: knees
Pain in Study Knee at 6 Yr Number Analyzed 47 knees [1] 
8
  17.0%
Pain in Study Knee at 7 Yr Number Analyzed 79 knees [2] 
9
  11.4%
Pain in Study Knee at 8 Yr Number Analyzed 93 knees
8
   8.6%
Pain in Study Knee at 9 Yr Number Analyzed 87 knees [3] 
9
  10.3%
Pain in Study Knee at 10 Yr Number Analyzed 91 knees [4] 
9
   9.9%
Satisfied with Results of Knee Replacement at 6 Yr Number Analyzed 47 knees [1] 
47
 100.0%
Satisfied with Results of Knee Replacement at 7 Yr Number Analyzed 79 knees [2] 
79
 100.0%
Satisfied with Results of Knee Replacement at 8 Yr Number Analyzed 93 knees
88
  94.6%
Satisfied with Results of Knee Replacement at 9 Yr Number Analyzed 87 knees [3] 
83
  95.4%
Satisfied with Results of Knee Replacement at 10Yr Number Analyzed 91 knees [4] 
89
  97.8%
Absence of Surgery on Study Knee at 6 Yr Number Analyzed 47 knees [1] 
47
 100.0%
Absence of Surgery on Study Knee at 7 Yr Number Analyzed 79 knees [2] 
79
 100.0%
Absence of Surgery on Study Knee at 8 Yr Number Analyzed 93 knees
93
 100.0%
Absence of Surgery on Study Knee at 9 Yr Number Analyzed 87 knees [3] 
87
 100.0%
Absence of Surgery on Study Knee at 10 Yr Number Analyzed 91 knees [4] 
91
 100.0%
[1]
46 participants
[2]
79 participants
[3]
87 participants
[4]
90 participants
10.Secondary Outcome
Title Implant Survivorship
Hide Description Implant survivorship at 10 years postoperative is determined using the Kaplan-Meier method.
Time Frame 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data.
Arm/Group Title Triathlon® CR Total Knee System
Hide Arm/Group Description:
Non-censored participants/knees who received the Triathlon® CR Total Knee System, and consented to the long-term follow-up study.
Overall Number of Participants Analyzed 411
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
440
Measure Type: Number
Unit of Measure: percentage of knees
Kaplan-Meier estimate (based on 5-year cases) Number Analyzed 440 knees
98.62
Kaplan-Meier estimate (based on 10-year cases) Number Analyzed 108 knees [1] 
100
[1]
106 participants
Time Frame To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Years 6-10 operative-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Adverse Event Reporting Description Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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 Adverse Events Systemic Adverse Events
Hide Arm/Group Description Participants who received the Triathlon® CR Total Knee System and were not censored from analysis. Operative-site events are reported by knee. Participants who received the Triathlon® CR Total Knee System and were not censored from analysis. Systemic events are reported by participant.
All-Cause Mortality
Operative-Site Adverse Events Systemic Adverse Events
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Operative-Site Adverse Events Systemic Adverse Events
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/440 (4.77%)      90/411 (21.90%)    
Blood and lymphatic system disorders     
Operative Site *  1/440 (0.23%)  1 0/0  0
Systemic *  0/0  0 3/411 (0.73%)  3
Cardiac disorders     
Systemic *  0/0  0 22/411 (5.35%)  25
Eye disorders     
Systemic *  0/0  0 1/411 (0.24%)  1
Gastrointestinal disorders     
Systemic *  0/0  0 16/411 (3.89%)  18
General disorders     
Systemic *  0/0  0 4/411 (0.97%)  4
Infections and infestations     
Systemic *  0/440 (0.00%)  0 5/411 (1.22%)  6
Injury, poisoning and procedural complications     
Systemic *  0/440 (0.00%)  0 1/411 (0.24%)  1
Musculoskeletal and connective tissue disorders     
Operative-Site *  13/440 (2.95%)  15 0/0  0
Systemic *  0/0  0 13/411 (3.16%)  14
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Systemic *  0/0  0 19/411 (4.62%)  26
Nervous system disorders     
Operative-Site *  2/440 (0.45%)  2 0/0  0
Systemic *  0/0  0 3/411 (0.73%)  4
Psychiatric disorders     
Systemic *  0/0  0 1/411 (0.24%)  1
Renal and urinary disorders     
Systemic *  0/0  0 6/411 (1.46%)  6
Reproductive system and breast disorders     
Systemic *  0/0  0 1/411 (0.24%)  1
Respiratory, thoracic and mediastinal disorders     
Operative-Site *  3/440 (0.68%)  3 0/0  0
Systemic *  0/0  0 11/411 (2.68%)  11
Skin and subcutaneous tissue disorders     
Systemic *  0/440 (0.00%)  0 1/411 (0.24%)  1
Vascular disorders     
Operative-Site *  5/440 (1.14%)  5 0/0  0
Systemic *  0/0  0 10/411 (2.43%)  10
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Operative-Site Adverse Events Systemic Adverse Events
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   79/440 (17.95%)      0/411 (0.00%)    
Musculoskeletal and connective tissue disorders     
Operative Site *  79/440 (17.95%)  93 0/411 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Each investigator shall have privileges for their own center’s results at the completion of the study. These manuscripts and 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 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.
Results Point of Contact
Name/Title: Director of Clinical Research
Organization: Stryker Orthopaedics
Phone: 201-831-5401
Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00957723     History of Changes
Other Study ID Numbers: 56
First Submitted: August 10, 2009
First Posted: August 12, 2009
Results First Submitted: June 13, 2013
Results First Posted: April 8, 2014
Last Update Posted: October 12, 2018