Triathlon Total Stabilizer (TS) Outcomes Study

• Sponsor: Stryker Orthopaedics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00958789
• Collaborator: (none)
• Enrollment: 180
• Locations: 12
• Arm: 1
• Duration (Months): 116.9
• Patients Per Site: 15
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study will be a prospective, non-randomized evaluation of the change between preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee System for a revision knee operation. The mean total Knee Society Score (for pain, motion and function) change is not 10% worse than, or is superior to, the expected change according to published revision total knee replacement data, for cases implanted with the Triathlon® TS Total Knee System as compared from preoperative to 2 years postoperative.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty, Replacement, Knee	Device: Triathlon TS Knee System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Total Stabilizer (TS) Total Knee System
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Apr 25, 2016
• Actual Study Completion Date: Mar 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Triathlon TS Knee Triathlon TS Knee System	Device: Triathlon TS Knee System; Total knee replacement for revision cases

Outcome Measures

Primary Outcome Measures

1. Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years [pre-op, 2 years]

   KSS Pain score, KSS Function score, Total Combined KSS The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (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. Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200).

Secondary Outcome Measures

1. Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative [2 years, 5 years]

   This outcome measure shows the results of the KSS Functional Score for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to > 5mm. The Functional Score of the Knee Society Clinical Rating System ranges from a potential minimum score of 0 to a maximum score of 100 points. It is based on points assigned to ability to walk, climb stairs and the use of ambulatory aids. A higher value represents a better outcome.

2. Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative [2 year and 5 year postoperative]

   Measures the knee stability results for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by amount in mm that the joint line was restored to physiological joint line postoperative. One group were restored to ≤ 5 mm and the other were restored to > 5mm. Knee stability is evaluated in the anterior-posterior (AP) and medial-lateral (ML) planes. AP drawer test determines instability in mm of the tibia. It was done in the AP plane in both JLR groupings (≤ 5mm and > 5mm) at 2 years and 5 years. The AP measurements were sub categorized into 5mm and 5-10mm. ML is tested with a varus valgus stress test to determine any instability as measured in degrees. The ML measurements were done in both JLR groupings (≤ 5mm and > 5mm) at 2 years and 5 years with all results in only one category of < 5 degrees. The higher the number of degrees or mm measured the more instability in the knee.

3. Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative [2 year and 5 year postoperative]

   Measures the presence or absence of anterior knee pain in the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to > 5mm. Anterior knee pain is determined by clinical examination with patient and clinician whether it is present or absent.

4. Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits [pre-op, 1, 2, 5 years]

   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.

5. Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative [1, 2, 5 years]

   The scoring system was based on the Knee Society guidelines and determined by measuring the width of the radiolucent lines for each of the zones of the implant components in millimeters. The total widths are added for each zone which produces a numerical score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Failure is defined as a score of 10 or greater, regardless of symptoms and considered as radiographic instability.

6. Number of Knees With a Revision of Femoral and/or Tibial Baseplate Component [5 years]

   Revision was defined as the removal of either the femoral component or the tibial baseplate component.

7. Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits [pre-op, 1, 2, 5 years]

   KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

8. Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits [pre-op, 1, 2, 5 years]

   The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint. It consists of one score from 0-100 with a score of 100 indicating no pain, no functional limitations, no tenderness or crepitus and normal quadriceps strength.

9. Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits [pre-op, 1, 2, 5 years]

   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.

10. Knee Society Score (KSS) Change From Pre-op to Post-op Visits [pre-op, 1,2, 5 year]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.

• Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.

• Patient is a candidate for revision of all femoral and tibial components of a total knee replacement.

• Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

• Patient has a Body Mass Index (BMI) > 40.

• Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.

• Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.

• Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.

• Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).

• Patient has a failed unicondylar knee prosthesis.

• Patient has a known sensitivity to device materials.

• Patient is a prisoner.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The CORE Institute	Phoenix	Arizona	United States	85023
2	Heekin Institute for Orthopedic Research	Jacksonville	Florida	United States	32204
3	Midwest Orthopaedics at Rush	Chicago	Illinois	United States	60612
4	Tufts Medical Center	Boston	Massachusetts	United States	02111
5	Rothman Institute	Egg Harbor Township	New Jersey	United States	08234
6	Ridgewood Orthopedics	Ridgewood	New Jersey	United States	07450
7	Upstate Bone and Joint Center	East Syracuse	New York	United States	13057
8	University of North Carolina Orthopedics	Chapel Hill	North Carolina	United States	27599
9	Duke University Medical Center	Durham	North Carolina	United States	27703
10	Wellington Orthopaedic & Sports Medicine	Cincinnati	Ohio	United States	45255
11	The Orthopaedic Center	Tulsa	Oklahoma	United States	74120
12	Scott & White Clinic	Temple	Texas	United States	76508

Sponsors and Collaborators

• Stryker Orthopaedics

Investigators

• Study Chair: Kirby D Hitt, M.D., Scott & White Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 27, 2013
• Informed Consent Form - Apr 28, 2008

More Information

Publications

None provided.

• Responsible Party: Stryker Orthopaedics
• ClinicalTrials.gov Identifier: NCT00958789
• Other Study ID Numbers: 65
• First Posted: Aug 13, 2009
• Last Update Posted: Oct 22, 2021
• Last Verified: Oct 1, 2021

Study Results

Participant Flow

Pre-assignment Detail	226 participants/228 knees were enrolled in the study. 47 participants/47 knees were censored from the main cohort. One bilateral participant had one knee censored and one knee included in study so this participant counts in the total. Therefore, 180 participants/181 knees are followed and applicable data is reflected in this record.

Arm/Group Title	Triathlon TS Knee
Arm/Group Description	Triathlon TS Knee System: Total knee replacement for revision cases
Period Title: Overall Study
STARTED	180
COMPLETED	130
NOT COMPLETED	50

Baseline Characteristics

Arm/Group Title	Triathlon TS Knee
Arm/Group Description	Triathlon TS Knee System: Total knee replacement for revision cases
Overall Participants	180
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.25 (9.59)
Sex: Female, Male (Count of Participants)
Female	99 55%
Male	81 45%

Outcome Measures

1. Primary Outcome

Title	Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
Description	KSS Pain score, KSS Function score, Total Combined KSS The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (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. Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200).
Time Frame	pre-op, 2 years

Outcome Measure Data

Analysis Population Description

KSS Function Score at 2 years - One case had a calculable score for Function and not for Pain/Motion. Therefore, the case was not included in the Combined KSS Score and Participant Flow completed total of 130.

Arm/Group Title	Triathlon TS Knee
Arm/Group Description	Triathlon TS Knee System: Total knee replacement for revision cases
Measure Participants	177
Measure knees	178
KSS Pain/motion score preoperative	39.81 (21.12)
KSS Pain/motion score 2 yrs.	83.97 (15.95)
KSS Function score preoperative	41.43 (23.09)
KSS Function score 2 yrs.	72.90 (25.12)
Combined KSS score preoperative	82.96 (34.96)
Combined KSS score 2 yrs.	157.05 (36.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Triathlon TS Knee
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	For the primary efficacy hypothesis, H0, the total KSS change from preoperative to 2 years postoperative will be less than or equal to delta. The alternative hypothesis, Ha, will be that the total KSS change from preop to 2 years postoperative is greater than delta. When delta=63, the hypothesis will test for non-inferiority. When delta=70, the hypothesis will test for superiority. H0: mean 2-year - mean preop less than or equal to delta. Ha: mean 2-year - mean preop greater than delta.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	70.70
	Confidence Interval	(1-Sided) 95%; 64.43 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Description	This outcome measure shows the results of the KSS Functional Score for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to > 5mm. The Functional Score of the Knee Society Clinical Rating System ranges from a potential minimum score of 0 to a maximum score of 100 points. It is based on points assigned to ability to walk, climb stairs and the use of ambulatory aids. A higher value represents a better outcome.
Time Frame	2 years, 5 years

Outcome Measure Data

Analysis Population Description

Data based on knees with available radiographic and clinical data at 2 years and 5 years postoperative.

Arm/Group Title	Joint Line Restoration (JLR) ≤ 5 mm	Joint Line Restoration (JLR) > 5 mm
Arm/Group Description	The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.	The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
Measure Participants	49	32
Measure Knees	49	32
KSS Function Score at 2yr	75.31 (22.81)	70.00 (25.02)
KSS Function Score at 5yr	66.82 (23.31)	71.36 (26.78)

3. Secondary Outcome

Title	Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative
Description	Measures the knee stability results for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by amount in mm that the joint line was restored to physiological joint line postoperative. One group were restored to ≤ 5 mm and the other were restored to > 5mm. Knee stability is evaluated in the anterior-posterior (AP) and medial-lateral (ML) planes. AP drawer test determines instability in mm of the tibia. It was done in the AP plane in both JLR groupings (≤ 5mm and > 5mm) at 2 years and 5 years. The AP measurements were sub categorized into 5mm and 5-10mm. ML is tested with a varus valgus stress test to determine any instability as measured in degrees. The ML measurements were done in both JLR groupings (≤ 5mm and > 5mm) at 2 years and 5 years with all results in only one category of < 5 degrees. The higher the number of degrees or mm measured the more instability in the knee.
Time Frame	2 year and 5 year postoperative

Outcome Measure Data

Analysis Population Description

Data based on knees with available radiographic and clinical data at 2 years and 5 years postoperative.

Arm/Group Title	Joint Line Restoration (JLR) ≤ 5 mm	Joint Line Restoration (JLR) > 5mm
Arm/Group Description	The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.	The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
Measure Participants	49	32
Measure Knees	49	32
Knee Stability AP < 5mm at 2 years	47	29
Knee Stability AP 5-10mm at 2 years	2	3
Knee Stability AP < 5mm at 5 years	30	21
Knee Stability AP 5-10mm at 5 years	1	1
Knee Stability ML< 5 degrees at 2 years	49	32
Knee Stability ML < 5 degrees at 5 years	31	22

4. Secondary Outcome

Title	Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Description	Measures the presence or absence of anterior knee pain in the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to > 5mm. Anterior knee pain is determined by clinical examination with patient and clinician whether it is present or absent.
Time Frame	2 year and 5 year postoperative

Outcome Measure Data

Analysis Population Description

Data based on knees with available radiographic and clinical data at 2 years and 5 years postoperative. There was an one more anterior knee pain evaluation as compared to knee stability and KSS Function as there was one missing value on those two evaluations.

Arm/Group Title	Joint Line Restoration (JLR) ≤ 5 mm	Joint Line Restoration (JLR) > 5 mm
Arm/Group Description	The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.	The Joint Line Restoration (JLR) is a measure in mm that the joint line was restored to the physiological joint line postoperative.
Measure Participants	50	32
Measure Knees	50	32
Anterior Knee Pain Absent at 2 yrs	45	28
Anterior Knee Pain Present at 2 yrs.	5	4
Anterior Knee Pain Absent at 5 yrs.	26	20
Anterior Knee Pain Present at 5 yrs.	7	2

5. Secondary Outcome

Title	Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
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	pre-op, 1, 2, 5 years

Outcome Measure Data

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 TS Knee
Arm/Group Description	Triathlon TS Knee System Triathlon TS Knee System: Total knee replacement for revision cases
Measure Participants	178
Measure Knees	179
SF-36 Physical Score Preoperative	32.43 (8.07)
SF-36 Physical Score 1 year	41.30 (10.49)
SF-36 Physical Score 2 year	40.55 (11.60)
SF-36 Physical Score 5 year	38.42 (10.44)
SF-36 Mental Score Preoperative	45.85 (14.81)
SF-36 Mental Score 1 year	52.57 (12.33)
SF-36 Mental Score 2 year	52.42 (11.99)
SF-36 Mental Score 5 years	54.07 (11.81)

6. Secondary Outcome

Title	Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative
Description	The scoring system was based on the Knee Society guidelines and determined by measuring the width of the radiolucent lines for each of the zones of the implant components in millimeters. The total widths are added for each zone which produces a numerical score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Failure is defined as a score of 10 or greater, regardless of symptoms and considered as radiographic instability.
Time Frame	1, 2, 5 years

Outcome Measure Data

Analysis Population Description

Data based on knees with available data at 1, 2 and 5 years postoperative at the tibial and femoral component interface.

Arm/Group Title	Triathlon TS Knee
Arm/Group Description	Triathlon TS Knee System: Total knee replacement for revision cases
Measure Participants	148
Measure Knees	149
Radiographically unstable at 1 year	2
Radiographically unstable at 2 year	0
Radiographically unstable at 5 year	0

7. Secondary Outcome

Title	Number of Knees With a Revision of Femoral and/or Tibial Baseplate Component
Description	Revision was defined as the removal of either the femoral component or the tibial baseplate component.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Knees enrolled in the study.

Arm/Group Title	Triathlon TS Knee
Arm/Group Description	Triathlon TS Knee System: Total knee replacement for revision cases
Measure Participants	180
Measure Knees	181
Aseptic Loosening	5
Septic Loosening	9

8. Secondary Outcome

Title	Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
Description	KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time Frame	pre-op, 1, 2, 5 years

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Triathlon TS Knee
Arm/Group Description	Triathlon TS Knee System: Total knee replacement for revision cases
Measure Participants	179
Measure Knees	180
KOOS Pain Preoperative	41.51 (18.91)
KOOS Pain 1 year	75.09 (21.55)
KOOS Pain 2 year	74.67 (21.36)
KOOS Pain 5 year	73.95 (21.31)
KOOS Symptoms Preoperative	43.39 (18.93)
KOOS Symptoms 1 year	73.02 (21.02)
KOOS Symptoms 2 year	72.95 (19.11)
KOOS Symptoms 5 year	75.88 (17.25)
KOOS Daily Living Preoperative	45.56 (20.41)
KOOS Daily Living 1 year	76.43 (21.19)
KOOS Daily Living 2 year	76.17 (21.83)
KOOS Daily Living 5 year	74.99 (20.34)
KOOS Function Sports and Recreational Preoperative	12.56 (19.95)
KOOS Function Sports and Recreational 1 year	44.10 (34.39)
KOOS Function Sports and Recreational 2 year	41.86 (33.26)
KOOS Function Sports and Recreational 5 year	42.77 (43.41)
KOOS Quality of Life Preoperative	18.06 (17.90)
KOOS Quality of Life 1 year	55.99 (28.20)
KOOS Quality of Life 2 year	55.74 (27.71)
KOOS Quality of Life 5 year	57.37 (27.56)

9. Secondary Outcome

Title	Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits
Description	The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint. It consists of one score from 0-100 with a score of 100 indicating no pain, no functional limitations, no tenderness or crepitus and normal quadriceps strength.
Time Frame	pre-op, 1, 2, 5 years

Outcome Measure Data

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 TS Knee
Arm/Group Description	Triathlon TS Knee System: Total knee replacement for revision cases
Measure Participants	170
Measure Knees	171
HSS Patella Score Preoperative	45.09 (18.43)
HSS Patella Score 1 year	76.68 (21.48)
HSS Patella Score 2 year	80.08 (19.31)
HSS Patella Score 5 year	78.56 (20.24)

10. Secondary Outcome

Title	Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits
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	pre-op, 1, 2, 5 years

Outcome Measure Data

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 TS Knee
Arm/Group Description	Triathlon TS Knee System: Total knee replacement for revision cases
Measure Participants	179
Measure Knees	180
LEAS Score Preoperative	7.80 (2.86)
LEAS Score 1 year	9.65 (3.18)
LEAS Score 2 year	9.60 (3.26)
LEAS Score 5 year	9.75 (3.39)

11. Secondary Outcome

Title	Knee Society Score (KSS) Change From Pre-op to Post-op Visits
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	pre-op, 1,2, 5 year

Outcome Measure Data

Analysis Population Description

Data based on knees with available data at 1,2 and 5 years postoperative.

Arm/Group Title	Triathlon TS Knee
Arm/Group Description	Triathlon TS Knee System: Total knee replacement for revision cases
Measure Participants	177
Measure Knees	178
Pain Motion Mean Preoperative	39.81 (21.12)
Pain Motion Mean 1 year	85.45 (15.14)
Pain Motion Mean 2 year	83.97 (15.95)
Pain Motion Mean 5 year	82.06 (17.24)
Function Mean Preoperative	41.43 (23.09)
Function Mean 1 year	74.18 (24.00)
Function Mean 2 year	72.90 (25.12)
Function Mean 5 year	70.71 (26.51)

Adverse Events

Time Frame	This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Adverse Event Reporting Description	Specific Adverse Event terms not used for all Adverse Events.
Arm/Group Title	Operative Adverse Events		Non-Operative Adverse Events
Arm/Group Description	Triathlon TS Knee System: Total knee replacement for revision cases Operative site events are reported by knee because in the case of bilateral participants (this is when one participant has both knees enrolled in the study), an event can occur in one knee, both knees or the same knee at different times and are counted separately for this reason.		Triathlon TS Knee System: Total knee replacement for revision cases Non-Operative Site Events are reported by participant.
All Cause Mortality
	Operative Adverse Events		Non-Operative Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/181 (0%)		7/180 (3.9%)
Serious Adverse Events
	Operative Adverse Events		Non-Operative Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/181 (20.4%)		40/180 (22.2%)
Blood and lymphatic system disorders
Non-operative Site	0/0 (NaN)	0	2/180 (1.1%)	2
Cardiac disorders
Non-operative Site	0/0 (NaN)	0	11/180 (6.1%)	11
Gastrointestinal disorders
Non-operative Site	0/0 (NaN)	0	5/180 (2.8%)	5
General disorders
Non-operative site	0/0 (NaN)	0	2/180 (1.1%)	2
Infections and infestations
Operative Site	15/181 (8.3%)	17	0/0 (NaN)	0
Non-operative Site	0/0 (NaN)	0	7/180 (3.9%)	8
Injury, poisoning and procedural complications
Operative Site	4/181 (2.2%)	4	0/0 (NaN)	0
Metabolism and nutrition disorders
Non-operative Site	0/0 (NaN)	0	1/180 (0.6%)	1
Musculoskeletal and connective tissue disorders
Non-operative Site	0/0 (NaN)	0	10/180 (5.6%)	14
Operative Site	24/181 (13.3%)	25	0/0 (NaN)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-operative Site	0/0 (NaN)	0	3/180 (1.7%)	3
Nervous system disorders
Non-operative Site	0/0 (NaN)	0	2/180 (1.1%)	2
Operative Site	0/0 (NaN)	0	0/0 (NaN)	0
Psychiatric disorders
Non-operative Site	0/0 (NaN)	0	2/180 (1.1%)	2
Renal and urinary disorders
Non-operative Site	0/0 (NaN)	0	5/180 (2.8%)	6
Operative Site	0/0 (NaN)	0	0/0 (NaN)	0
Reproductive system and breast disorders
Non-operative Site	0/0 (NaN)	0	1/180 (0.6%)	2
Respiratory, thoracic and mediastinal disorders
Non-operative Site	0/0 (NaN)	0	5/180 (2.8%)	9
Skin and subcutaneous tissue disorders
Non-operative Site	0/0 (NaN)	0	1/180 (0.6%)	1
Operative Site	0/0 (NaN)	0	0/0 (NaN)	0
Social circumstances
Non-operative Site	0/0 (NaN)	0	2/180 (1.1%)	2
Vascular disorders
Non-operative Site	0/0 (NaN)	0	5/180 (2.8%)	5
Other (Not Including Serious) Adverse Events
	Operative Adverse Events		Non-Operative Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	59/181 (32.6%)		0/180 (0%)
Musculoskeletal and connective tissue disorders
Operative Site	59/181 (32.6%)	66	0/0 (NaN)	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.