Trial Outcomes & Findings for Clinical Outcome Study for the Triathlon Cruciate Retaining (CR) Total Knee (NCT NCT02535741)

Last Updated: 2024-02-22

Results Overview

Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data.

Recruitment status

COMPLETED

Study phase

Target enrollment

168 participants

Primary outcome timeframe

2 years follow-up

Results posted on

2024-02-22

Participant Flow

The first patient included in the study was enrolled in October 2006. 168 cases received the Triathlon CR knee system over a 56 month period in a consecutive manner in 6 centers.

Participant milestones

Participant milestones
Measure	Triathlon CR Total Knee System Primary total knee replacement Triathlon CR Total Knee System: Primary total knee replacement
Overall Study STARTED	168
Overall Study COMPLETED	136
Overall Study NOT COMPLETED	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Triathlon CR Total Knee System Primary total knee replacement Triathlon CR Total Knee System: Primary total knee replacement
Overall Study Adverse Event	3
Overall Study Withdrawal by Subject	9
Overall Study Lost to Follow-up	10
Overall Study Exclusion criteria: Bilateral implant	4
Overall Study Missing data	6

Baseline Characteristics

Clinical Outcome Study for the Triathlon Cruciate Retaining (CR) Total Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triathlon CR Total Knee System n=168 Participants Progressive data: Primary total knee replacement
Age, Continuous	66 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	114 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants
Range of Motion (ROM)	107.21 degree STANDARD_DEVIATION 12.5 • n=5 Participants

PRIMARY outcome

Timeframe: 2 years follow-up

Population: Comparison to data from the literature was not done.

Outcome measures

Outcome measures
Measure	Triathlon CR Total Knee System n=134 Participants Prospective data of the Triathlon CR primary total knee replacement
Mean Triathlon CR Active Range of Motion (ROM)	112.96 degree Standard Deviation 13.708

SECONDARY outcome

Timeframe: Pre-operative, 3 months, 1, 2 and 5 years follow-up

Population: Radiographic data were not collected

Plain radiographs will be obtained for assessment of fixation of the device.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up

Population: The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.

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.

Outcome measures

Outcome measures
Measure	Triathlon CR Total Knee System n=164 Participants Prospective data of the Triathlon CR primary total knee replacement
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) KSS Pain/Motion pre-operative	38.2 units on a scale Standard Deviation 21.7
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) KSS Pain/Motion 3 months	75.2 units on a scale Standard Deviation 15.4
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) KSS Pain/Motion 1 year	81.7 units on a scale Standard Deviation 13.8
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) KSS Pain/Motion 2 years	86 units on a scale Standard Deviation 11.5
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) KSS Pain/Motion 5 years	88 units on a scale Standard Deviation 9.7
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) KSS Function Score pre-operative	58.9 units on a scale Standard Deviation 14.2
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) KSS Function Score 3 months	78.9 units on a scale Standard Deviation 17.5
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) KSS Function Score 1 year	82.2 units on a scale Standard Deviation 18.5
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) KSS Function Score 2 years	86.2 units on a scale Standard Deviation 18
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) KSS Function Score 5 years	81.5 units on a scale Standard Deviation 20.5

SECONDARY outcome

Timeframe: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up

Population: The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.

The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical (PSC) and mental status component (MCS) 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=163 Participants Prospective data of the Triathlon CR primary total knee replacement
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire 2 years MCS	50.8 units on a scale Standard Deviation 10.5
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire pre-operative PCS	30.0 units on a scale Standard Deviation 8.2
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire 3 months PCS	37.5 units on a scale Standard Deviation 8.8
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire 1 year PCS	42.0 units on a scale Standard Deviation 9.4
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire 2 years PCS	44.6 units on a scale Standard Deviation 9.7
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire 3 years PCS	41.9 units on a scale Standard Deviation 10.8
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire 4 years PCS	42.1 units on a scale Standard Deviation 10.7
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire 5 years PCS	43.0 units on a scale Standard Deviation 11.1
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire pre-operative MCS	47.5 units on a scale Standard Deviation 13.5
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire 3 months MCS	50.7 units on a scale Standard Deviation 10.8
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire 1 year MCS	52.2 units on a scale Standard Deviation 9.5
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire 3 years MCS	51.4 units on a scale Standard Deviation 11.3
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire 4 years MCS	50.7 units on a scale Standard Deviation 10.5
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire 5 years MCS	53.9 units on a scale Standard Deviation 10.3

SECONDARY outcome

Timeframe: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up

Population: The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.

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=159 Participants Prospective data of the Triathlon CR primary total knee replacement
Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire 5 years total score	43.64 units on a scale Standard Deviation 53.1
Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire 1 year total score	45.04 units on a scale Standard Deviation 47.14
Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire 2 years total score	40.6 units on a scale Standard Deviation 41.30
Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire 3 years total score	46.28 units on a scale Standard Deviation 51.02
Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire 4 years total score	47.94 units on a scale Standard Deviation 52.21
Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire pre-operative total score	166.42 units on a scale Standard Deviation 60.88
Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire 3 months total score	78.99 units on a scale Standard Deviation 58.98

Adverse Events

Triathlon CR Total Knee System

Serious events: 23 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Triathlon CR Total Knee System n=168 participants at risk Triathlon CR Primary total knee replacement
Nervous system disorders Apoplex	0.60% 1/168 • Number of events 1 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Musculoskeletal and connective tissue disorders Arthrofibrosis	3.6% 6/168 • Number of events 6 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Musculoskeletal and connective tissue disorders Loosening of tibial component	0.60% 1/168 • Number of events 1 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	1.2% 2/168 • Number of events 2 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Musculoskeletal and connective tissue disorders Contralateral knee pain	0.60% 1/168 • Number of events 1 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Musculoskeletal and connective tissue disorders Contralateral total knee replacement	4.2% 7/168 • Number of events 7 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Musculoskeletal and connective tissue disorders Hip Replacement	1.2% 2/168 • Number of events 2 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Renal and urinary disorders Deep joint infection	1.8% 3/168 • Number of events 3 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Renal and urinary disorders Haematuria	0.60% 1/168 • Number of events 1 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Musculoskeletal and connective tissue disorders Knee instability	1.2% 2/168 • Number of events 2 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Musculoskeletal and connective tissue disorders Knee pain	0.60% 1/168 • Number of events 1 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Vascular disorders Knee pain, poor ROM	0.60% 1/168 • Number of events 1 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Endocrine disorders Multinodular goiter	0.60% 1/168 • Number of events 1 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Musculoskeletal and connective tissue disorders Patellar Subluxation	1.2% 2/168 • Number of events 2 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Musculoskeletal and connective tissue disorders Poor ROM	0.60% 1/168 • Number of events 1 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Infections and infestations Pulmonal infection	0.60% 1/168 • Number of events 1 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Injury, poisoning and procedural complications Soft tissue trauma	1.2% 2/168 • Number of events 2 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
Musculoskeletal and connective tissue disorders Flexion Contracture	1.8% 3/168 • Number of events 3 • 3 months, 1 year, 2 years, 5 years Adverse event data were collected for the Triathlon CR arm during the follow-up visits.

Other adverse events

Adverse event data not reported

Additional Information

Doug McGurty

Stryker European Operations BV

Phone: +44(0)1635 500690

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60