Trial Outcomes & Findings for Journey 2 Multi Center Kinematic Study (NCT NCT05107414)

NCT ID: NCT05107414

Last Updated: 2026-06-23

Results Overview

The condylar rollback of the medial condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in \[mm\].

Recruitment status

COMPLETED

Target enrollment

201 participants

Primary outcome timeframe

Baseline, at time of observation

Results posted on

2026-06-23

Participant Flow

Subjects recruited from surgeon's previously implanted population

One knee analyzed per participant

Participant milestones

Participant milestones
Measure
Journey II Bi-Cruciate Stabilized
Participants who have been implanted with a Smith \& Nephew Journey II BCS TKA
Journey II Cruciate Retaining
Participants who have been implanted with a Smith \& Nephew Journey II CR TKA
Journey II Bi-Cruciate Retaining
Participants who have been implanted with a Smith \& Nephew Journey II BCR TKA
Overall Study
STARTED
101
71
29
Overall Study
COMPLETED
101
71
29
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Journey II Bi-Cruciate Stabilized
n=101 Participants
Participants who have been implanted with a Smith \& Nephew Journey II BCS TKA
Journey II Cruciate Retaining
n=71 Participants
Participants who have been implanted with a Smith \& Nephew Journey II CR TKA
Journey II Bi-Cruciate Retaining
n=29 Participants
Participants who have been implanted with a Smith \& Nephew Journey II BCR TKA
Total
n=201 Participants
Total of all reporting groups
Age, Continuous
65.2 years
STANDARD_DEVIATION 9.3 • n=101 Participants
67.9 years
STANDARD_DEVIATION 7.2 • n=71 Participants
64.9 years
STANDARD_DEVIATION 9.6 • n=29 Participants
66.0 years
STANDARD_DEVIATION 8.7 • n=201 Participants
Sex: Female, Male
Female
51 Participants
n=101 Participants
36 Participants
n=71 Participants
17 Participants
n=29 Participants
104 Participants
n=201 Participants
Sex: Female, Male
Male
50 Participants
n=101 Participants
35 Participants
n=71 Participants
12 Participants
n=29 Participants
97 Participants
n=201 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Baseline, at time of observation

The condylar rollback of the medial condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in \[mm\].

Outcome measures

Outcome measures
Measure
Journey II Bi-Cruciate Retaining
n=29 Participants
Participants who have been implanted with a Smith \& Nephew Journey II BCR TKA
Journey II Bi-Cruciate Stabilized
n=101 Participants
Participants who have been implanted with a Smith \& Nephew Journey II BCS TKA
Journey II Cruciate Retaining
n=71 Participants
Participants who have been implanted with a Smith \& Nephew Journey II CR TKA
Femorotibial Medial Condylar Rollback
-0.6 mm
Standard Deviation 4.4
-7.3 mm
Standard Deviation 3.9
1.1 mm
Standard Deviation 3.1

PRIMARY outcome

Timeframe: Baseline, at time of observation

The condylar rollback of the lateral condyle will be observed at a single instance in time. Higher rollback indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in \[mm\].

Outcome measures

Outcome measures
Measure
Journey II Bi-Cruciate Retaining
n=29 Participants
Participants who have been implanted with a Smith \& Nephew Journey II BCR TKA
Journey II Bi-Cruciate Stabilized
n=101 Participants
Participants who have been implanted with a Smith \& Nephew Journey II BCS TKA
Journey II Cruciate Retaining
n=71 Participants
Participants who have been implanted with a Smith \& Nephew Journey II CR TKA
Femorotibial Lateral Condylar Rollback
-5.2 mm
Standard Deviation 5.6
-13.5 mm
Standard Deviation 5.3
-4.5 mm
Standard Deviation 5.9

PRIMARY outcome

Timeframe: Baseline, at time of observation

The femorotibial axial rotation will be observed at a single instance in time. Higher rotation indicates more motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in \[deg\].

Outcome measures

Outcome measures
Measure
Journey II Bi-Cruciate Retaining
n=29 Participants
Participants who have been implanted with a Smith \& Nephew Journey II BCR TKA
Journey II Bi-Cruciate Stabilized
n=101 Participants
Participants who have been implanted with a Smith \& Nephew Journey II BCS TKA
Journey II Cruciate Retaining
n=71 Participants
Participants who have been implanted with a Smith \& Nephew Journey II CR TKA
Femorotibial Axial Rotation
6.1 degrees
Standard Deviation 4.7
7.6 degrees
Standard Deviation 5.5
6.8 degrees
Standard Deviation 6.2

PRIMARY outcome

Timeframe: Baseline, at time of observation

The femorotibial weight bearing flexion will be observed at a single instance in time. Higher flexion indicates greater range of motion and improved kinematics. Participants will have previously undergone a total knee arthroplasty but data cannot be collected on their preoperative kinematics. Outcome will be measured in \[deg\].

Outcome measures

Outcome measures
Measure
Journey II Bi-Cruciate Retaining
n=29 Participants
Participants who have been implanted with a Smith \& Nephew Journey II BCR TKA
Journey II Bi-Cruciate Stabilized
n=101 Participants
Participants who have been implanted with a Smith \& Nephew Journey II BCS TKA
Journey II Cruciate Retaining
n=71 Participants
Participants who have been implanted with a Smith \& Nephew Journey II CR TKA
Femorotibial Weight Bearing Flexion
115.0 degrees
Standard Deviation 14.4
116.3 degrees
Standard Deviation 15.1
113.9 degrees
Standard Deviation 11.4

Adverse Events

Journey II Bi-Cruciate Stabilized

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Journey II Cruciate Retaining

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Journey II Bi-Cruciate Retaining

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael LaCour

University of Tennessee

Phone: 865-974-4159

Results disclosure agreements

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