Trial Outcomes & Findings for Triathlon® Partial Knee Replacement (PKR) Outcomes Study (NCT NCT00966979)

Last Updated: 2023-09-13

Results Overview

The Knee Society Score (KSS) consists of two distinct sub-scores: one for pain, range of motion, joint stability and alignment (Pain/Motion KSS) and one for distance walked, stair climbing and walking aids (Functional KSS). This outcome measure was only for the KSS Function Score at 10-years. The KSS Function score subscale is 0-100, with 100 representing a better outcome. Although the specific scores are not distinguished as "excellent", "good", "fair", or "poor", a higher value represents a better outcome.

Recruitment status

TERMINATED

Study phase

Target enrollment

111 participants

Primary outcome timeframe

10 years

Results posted on

2023-09-13

Participant Flow

There were 112 knees in 111 patients that were enrolled in the study (one bilateral case).

Of the 111 participants enrolled, there were 23 cases that were censored due to not having the study device, surgery canceled or an inclusion exclusion violation. Therefore, 89 knees in 88 participants are followed who did receive the study device and met protocol criteria. Those applicable data are reflected in this record.

Unit of analysis: Knees

Participant milestones

Participant milestones
Measure	Triathlon PKR Unicompartmental Knee All subjects enrolled will receive the Triathlon PKR device. Triathlon PKR: Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee for a primary replacement indication.
Overall Study STARTED	111 112
Overall Study COMPLETED	13 13
Overall Study NOT COMPLETED	98 99

Reasons for withdrawal

Reasons for withdrawal
Measure	Triathlon PKR Unicompartmental Knee All subjects enrolled will receive the Triathlon PKR device. Triathlon PKR: Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee for a primary replacement indication.
Overall Study Death	1
Overall Study Lost to Follow-up	6
Overall Study Withdrawal by Subject	14
Overall Study Adverse Event	5
Overall Study Sponsor terminated early	49
Overall Study Censored because surgery not done	2
Overall Study Censored because study device was not implanted	14
Overall Study Censored because of Inclusion/exclusion violation	7

Baseline Characteristics

Triathlon® Partial Knee Replacement (PKR) Outcomes Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triathlon PKR n=88 Participants All subjects enrolled will receive the Triathlon PKR device. Triathlon PKR: Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee.
Age, Continuous	61.83 years n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	86 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 years

Population: Due to early study termination the primary outcome was only reached for a minimal number of participants (12) reaching 10 years. These only included prospective cases. No retrospective cases reached the 10-year time interval.

Outcome measures

Outcome measures
Measure	Triathlon PKR Unicompartmental Knee n=12 Knees All subjects enrolled will receive the Triathlon PKR device. Triathlon PKR: Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee for a primary replacement indication.
Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS).	98.33 units on a scale Standard Deviation 5.77

SECONDARY outcome

Timeframe: 10-years

Population: This primary outcome measure at 10 years is a statistical estimation based on 80 prospective knees as per the protocol.

For the purpose of this study the Kaplan-Meier survival curves are a statistical method to estimate the survival function from lifetime data of a knee replacement after treatment. Survivorship is defined as a percentage of knees free of any component revision for any reason.

Outcome measures

Outcome measures
Measure	Triathlon PKR Unicompartmental Knee n=80 Knees All subjects enrolled will receive the Triathlon PKR device. Triathlon PKR: Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee for a primary replacement indication.
10-years Kaplan Meier Survival Analysis	91.35 percentage of knees Interval 80.12 to 96.37

Adverse Events

Operative Adverse Events

Serious events: 11 serious events

Other events: 26 other events

Deaths: 0 deaths

Non-Operative Adverse Events

Serious events: 20 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Operative Adverse Events n=89 participants at risk Operative site adverse 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.	Non-Operative Adverse Events n=88 participants at risk Non-operative site adverse events are reported by participant.
Cardiac disorders Non-operative	— 0/0 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.	6.8% 6/88 • Number of events 6 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.
Gastrointestinal disorders Non-operative	— 0/0 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.	3.4% 3/88 • Number of events 3 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.
General disorders Non-operative	— 0/0 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.	2.3% 2/88 • Number of events 2 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.
Injury, poisoning and procedural complications Operative site	1.1% 1/89 • Number of events 1 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.	— 0/0 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.
Musculoskeletal and connective tissue disorders Operative site	11.2% 10/89 • Number of events 10 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.	— 0/0 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-operative	— 0/0 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.	4.5% 4/88 • Number of events 4 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.
Psychiatric disorders Non-operative site	— 0/0 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.	1.1% 1/88 • Number of events 1 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.
Renal and urinary disorders Non-operative	— 0/0 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.	2.3% 2/88 • Number of events 2 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.
Respiratory, thoracic and mediastinal disorders Non-operative	— 0/0 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.	1.1% 1/88 • Number of events 1 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.
Vascular disorders Non-operative	— 0/0 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.	1.1% 1/88 • Number of events 1 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.

Other adverse events

Other adverse events
Measure	Operative Adverse Events n=89 participants at risk Operative site adverse 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.	Non-Operative Adverse Events n=88 participants at risk Non-operative site adverse events are reported by participant.
Musculoskeletal and connective tissue disorders Operative	29.2% 26/89 • Number of events 26 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.	0.00% 0/88 • This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval. The date of occurrence, date diagnosed, type of complication/adverse event and treatment were collected.

Additional Information

Stryker JR Clinical Research

Stryker Orthopaedics

Phone: 201-831-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There is an agreement between Principal Investigators and the Sponsor (or its agents) that requires Investigators to allow Sponsor at least 60 days to review material intended for publications to ensure that confidential information is not disclosed and that the data is accurately represented. The investigators can submit publication proposals prior to the study completion date for Sponsor consideration and for up to 7 years after study completion.
Publication restrictions are in place

Restriction type: OTHER