Trial Outcomes & Findings for Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study (NCT NCT00957723)

NCT ID: NCT00957723

Last Updated: 2018-10-12

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

419 participants

Primary outcome timeframe

2 Years

Results posted on

2018-10-12

Participant Flow

467/500 participants/knees enrolled;56 participants/60 knees censored = 411/440 participants/knees followed

Participant milestones

Participant milestones
Measure	Triathlon® CR Total Knee System 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.
Overall Study STARTED	411
Overall Study COMPLETED	298
Overall Study NOT COMPLETED	113

Reasons for withdrawal

Reasons for withdrawal
Measure	Triathlon® CR Total Knee System 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.
Overall Study Death	3
Overall Study Revision/ Removal of Study Implant	3
Overall Study Lost to Follow-up	8
Overall Study Withdrawal by Subject	24
Overall Study Investigative Site Terminated	61
Overall Study Intercurrent Illness	2
Overall Study 2yr ROM Data Not Evaluable	12

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triathlon® CR Total Knee System n=411 Participants Participants who received the Triathlon® CR Total Knee System and were not censored from analysis.
Age, Continuous	65.5 years STANDARD_DEVIATION 8.63 • n=5 Participants
Sex: Female, Male Female	239 Participants n=5 Participants
Sex: Female, Male Male	172 Participants n=5 Participants
Region of Enrollment United States	411 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 Years

Population: Participants/knees with available data.

Outcome measures

Outcome measures
Measure	Triathlon® CR Total Knee System n=298 Participants Non-censored participants/knees who received the Triathlon® CR Total Knee System
Active Range of Motion	119.2 Degrees Standard Deviation 10.66

SECONDARY outcome

Timeframe: preoperative, 1, 2, and 5 years

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

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.

Outcome measures

Outcome measures
Measure	Triathlon® CR Total Knee System n=439 knees Non-censored participants/knees who received the Triathlon® CR Total Knee System
Change in Knee Society Score (KSS) Over Time Pain/Motion Mean 1 Year Score	92.12 units on a scale Standard Deviation 10.13
Change in Knee Society Score (KSS) Over Time Pain/Motion Mean Preoperative Score	37.39 units on a scale Standard Deviation 13.80
Change in Knee Society Score (KSS) Over Time Pain/Motion Mean 2 Year Score	93.83 units on a scale Standard Deviation 7.93
Change in Knee Society Score (KSS) Over Time Pain/Motion Mean 5 Year Score	94.86 units on a scale Standard Deviation 8.48
Change in Knee Society Score (KSS) Over Time Function Mean Preoperative Score	53.34 units on a scale Standard Deviation 17.46
Change in Knee Society Score (KSS) Over Time Function Mean 1 Year Score	86.04 units on a scale Standard Deviation 17.40
Change in Knee Society Score (KSS) Over Time Function Mean 2 Year Score	86.08 units on a scale Standard Deviation 17.98
Change in Knee Society Score (KSS) Over Time Function Mean 5 Year Score	85.49 units on a scale Standard Deviation 19.62

SECONDARY outcome

Timeframe: 1, 2, and 5 years

Population: Participants/knees with available data. Overall number of participants and units analyzed is based upon preoperative population.

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.

Outcome measures

Outcome measures
Measure	Triathlon® CR Total Knee System n=386 knees Non-censored participants/knees who received the Triathlon® CR Total Knee System
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) Active Flexion 1 Year	118.47 degrees Standard Deviation 10.59
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) Active Flexion 2 Years	119.53 degrees Standard Deviation 10.26
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) Active Flexion 5 Years	120.74 degrees Standard Deviation 9.00
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) Active Extension 1 Year	0.37 degrees Standard Deviation 1.66
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) Active Extension 2 Years	0.28 degrees Standard Deviation 1.71
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) Active Extension 5 Years	0.26 degrees Standard Deviation 1.49
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) Passive Flexion 1 Year	121.55 degrees Standard Deviation 10.43
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) Passive Flexion 2 Years	122.89 degrees Standard Deviation 10.39
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) Passive Flexion 5 Years	123.41 degrees Standard Deviation 8.53
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) Passive Extension 1 Year	0.19 degrees Standard Deviation 1.23
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) Passive Extension 2 Years	0.08 degrees Standard Deviation 0.91
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) Passive Extension 5 Years	0.16 degrees Standard Deviation 1.01

SECONDARY outcome

Timeframe: 1, 2, and 5 years

Population: Participants/knees with available data. Overall number of participants and units analyzed is based upon the one year population.

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.

Outcome measures

Outcome measures
Measure	Triathlon® CR Total Knee System n=370 knees Non-censored participants/knees who received the Triathlon® CR Total Knee System
Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score Radiographic Failure at 1 Year	1 Total number of knees
Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score Radiographic Failure at 2 Years	1 Total number of knees
Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score Radiographic Failure at 5 Years	0 Total number of knees

SECONDARY outcome

Timeframe: preoperative, 1, 2, 3, 4, and 5 years

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

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.

Outcome measures

Outcome measures
Measure	Triathlon® CR Total Knee System n=432 knees Non-censored participants/knees who received the Triathlon® CR Total Knee System
Change in SF-36 Health Survey Over Time Physical Score 3 Years	46.94 units on a scale Standard Deviation 9.06
Change in SF-36 Health Survey Over Time Physical Score 4 Years	46.22 units on a scale Standard Deviation 9.46
Change in SF-36 Health Survey Over Time Physical score 5 Years	46.04 units on a scale Standard Deviation 9.57
Change in SF-36 Health Survey Over Time Mental Score Preoperative	52.55 units on a scale Standard Deviation 12.13
Change in SF-36 Health Survey Over Time Mental Score 4 Years	54.72 units on a scale Standard Deviation 7.87
Change in SF-36 Health Survey Over Time Physical Score Preoperative	32.54 units on a scale Standard Deviation 7.50
Change in SF-36 Health Survey Over Time Physical Score 1 Year	47.77 units on a scale Standard Deviation 7.96
Change in SF-36 Health Survey Over Time Physical Score 2 Years	47.48 units on a scale Standard Deviation 8.71
Change in SF-36 Health Survey Over Time Mental Score 1 Year	55.60 units on a scale Standard Deviation 7.79
Change in SF-36 Health Survey Over Time Mental Score 2 Years	55.79 units on a scale Standard Deviation 7.86
Change in SF-36 Health Survey Over Time Mental Score 3 Years	55.53 units on a scale Standard Deviation 7.72
Change in SF-36 Health Survey Over Time Mental Score 5 Years	55.65 units on a scale Standard Deviation 8.37

SECONDARY outcome

Timeframe: preoperative,1, 2, 3, 4 and 5 years

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Triathlon® CR Total Knee System n=97 knees Non-censored participants/knees who received the Triathlon® CR Total Knee System
Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time Total WOMAC 2 Years	94.54 units on a scale
Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time Total WOMAC 3 Years	11.68 units on a scale
Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time Total WOMAC 4 Years	36.33 units on a scale Standard Deviation 48.92
Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time Total WOMAC 5 Years	26.71 units on a scale Standard Deviation 36.18

SECONDARY outcome

Timeframe: preoperative, 1, 2, 3, 4, and 5 years

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

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.

Outcome measures

Outcome measures
Measure	Triathlon® CR Total Knee System n=438 knees Non-censored participants/knees who received the Triathlon® CR Total Knee System
Change in Lower-Extremity Activity Scale (LEAS) Over Time LEAS 1 Year	11.22 units on a scale Standard Deviation 2.71
Change in Lower-Extremity Activity Scale (LEAS) Over Time LEAS 2 Years	11.45 units on a scale Standard Deviation 2.91
Change in Lower-Extremity Activity Scale (LEAS) Over Time LEAS Preoperative	9.30 units on a scale Standard Deviation 2.87
Change in Lower-Extremity Activity Scale (LEAS) Over Time LEAS 3 Years	11.10 units on a scale Standard Deviation 2.76
Change in Lower-Extremity Activity Scale (LEAS) Over Time LEAS 4 Years	11.10 units on a scale Standard Deviation 2.89
Change in Lower-Extremity Activity Scale (LEAS) Over Time LEAS 5 Years	11.44 units on a scale Standard Deviation 2.94

SECONDARY outcome

Timeframe: 5 years

Population: Participants/knees with available data at 5 years.

The incidence of patellar subluxation, dislocation or fracture is reported.

Outcome measures

Outcome measures
Measure	Triathlon® CR Total Knee System n=215 knees Non-censored participants/knees who received the Triathlon® CR Total Knee System
Patellar Subluxation, Dislocation and Fracture Rate Patellar fracture	4 knees
Patellar Subluxation, Dislocation and Fracture Rate Patellar subluxation	0 knees
Patellar Subluxation, Dislocation and Fracture Rate Patellar dislocation	0 knees

SECONDARY outcome

Timeframe: 6, 7, 8, 9, and 10 years

Population: 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.

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?

Outcome measures

Outcome measures
Measure	Triathlon® CR Total Knee System n=93 knees Non-censored participants/knees who received the Triathlon® CR Total Knee System
Patient Outcome Long Term Follow-up Questionnaire Over Time Satisfied with Results of Knee Replacement at 8 Yr	88 knees
Patient Outcome Long Term Follow-up Questionnaire Over Time Satisfied with Results of Knee Replacement at 9 Yr	83 knees
Patient Outcome Long Term Follow-up Questionnaire Over Time Satisfied with Results of Knee Replacement at 10Yr	89 knees
Patient Outcome Long Term Follow-up Questionnaire Over Time Absence of Surgery on Study Knee at 6 Yr	47 knees
Patient Outcome Long Term Follow-up Questionnaire Over Time Absence of Surgery on Study Knee at 7 Yr	79 knees
Patient Outcome Long Term Follow-up Questionnaire Over Time Absence of Surgery on Study Knee at 8 Yr	93 knees
Patient Outcome Long Term Follow-up Questionnaire Over Time Absence of Surgery on Study Knee at 9 Yr	87 knees
Patient Outcome Long Term Follow-up Questionnaire Over Time Pain in Study Knee at 6 Yr	8 knees
Patient Outcome Long Term Follow-up Questionnaire Over Time Absence of Surgery on Study Knee at 10 Yr	91 knees
Patient Outcome Long Term Follow-up Questionnaire Over Time Pain in Study Knee at 7 Yr	9 knees
Patient Outcome Long Term Follow-up Questionnaire Over Time Pain in Study Knee at 8 Yr	8 knees
Patient Outcome Long Term Follow-up Questionnaire Over Time Pain in Study Knee at 9 Yr	9 knees
Patient Outcome Long Term Follow-up Questionnaire Over Time Pain in Study Knee at 10 Yr	9 knees
Patient Outcome Long Term Follow-up Questionnaire Over Time Satisfied with Results of Knee Replacement at 6 Yr	47 knees
Patient Outcome Long Term Follow-up Questionnaire Over Time Satisfied with Results of Knee Replacement at 7 Yr	79 knees

SECONDARY outcome

Timeframe: 10 years

Population: Participants with available data.

Implant survivorship at 10 years postoperative is determined using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Triathlon® CR Total Knee System n=440 knees Non-censored participants/knees who received the Triathlon® CR Total Knee System
Implant Survivorship Kaplan-Meier estimate (based on 10-year cases)	100 percentage of knees
Implant Survivorship Kaplan-Meier estimate (based on 5-year cases)	98.62 percentage of knees

Adverse Events

Operative-Site Adverse Events

Serious events: 21 serious events

Other events: 79 other events

Deaths: 0 deaths

Systemic Adverse Events

Serious events: 90 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Operative-Site Adverse Events n=440 participants at risk Participants who received the Triathlon® CR Total Knee System and were not censored from analysis. Operative-site events are reported by knee.	Systemic Adverse Events n=411 participants at risk Participants who received the Triathlon® CR Total Knee System and were not censored from analysis. Systemic events are reported by participant.
Musculoskeletal and connective tissue disorders Operative Site	18.0% 79/440 • Number of events 93 • 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. 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.	0.00% 0/411 • 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. 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.

Additional Information

Director of Clinical Research

Stryker Orthopaedics

Phone: 201-831-5401

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER