Trial Outcomes & Findings for In Vivo Kinematics for Subjects With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA (NCT NCT04612036)

Results Overview

Anterior Posterior (AP) translations, in mm, of medial femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.

Recruitment status

COMPLETED

Target enrollment

60 participants

Primary outcome timeframe

At least 6 months postoperative

Results posted on

2023-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	Journey II Bi-Cruciate Stabilized Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected Journey II Bi-Cruciate Stabilized TKA: Total Knee Arthroplasty System	Journey II Cruciate Retaining Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained) Journey II Cruciate Retaining TKA: Total Knee Arthroplasty System	Journey II Bi-Cruciate Retaining Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained Journey II Bi-Cruciate Retaining TKA: Total Knee Arthroplasty System
Overall Study STARTED	25	25	10
Overall Study COMPLETED	25	25	10
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=25 Participants Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected Journey II Bi-Cruciate Stabilized TKA: Total Knee Arthroplasty System	Journey II Cruciate Retaining n=25 Participants Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained) Journey II Cruciate Retaining TKA: Total Knee Arthroplasty System	Journey II Bi-Cruciate Retaining n=10 Participants Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained Journey II Bi-Cruciate Retaining TKA: Total Knee Arthroplasty System	Total n=60 Participants Total of all reporting groups
Age, Customized <18	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=10 Participants	0 Participants n=60 Participants
Age, Customized 18-85	25 Participants n=25 Participants	25 Participants n=25 Participants	10 Participants n=10 Participants	60 Participants n=60 Participants
Age, Customized 85+	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=10 Participants	0 Participants n=60 Participants
Sex: Female, Male Female	18 Participants n=25 Participants	17 Participants n=25 Participants	5 Participants n=10 Participants	40 Participants n=60 Participants
Sex: Female, Male Male	7 Participants n=25 Participants	8 Participants n=25 Participants	5 Participants n=10 Participants	20 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: At least 6 months postoperative

Anterior Posterior (AP) translations, in mm, of medial femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.

Outcome measures

Outcome measures
Measure	Journey II Bi-Cruciate Stabilized n=25 Participants Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected Journey II Bi-Cruciate Stabilized TKA: Total Knee Arthroplasty System	Journey II Cruciate Retaining n=25 Participants Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained) Journey II Cruciate Retaining TKA: Total Knee Arthroplasty System	Journey II Bi-Cruciate Retaining n=10 Participants Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained Journey II Bi-Cruciate Retaining TKA: Total Knee Arthroplasty System
Medial AP Translations, in mm	-6.9 millimeters Standard Deviation 2.8	-0.2 millimeters Standard Deviation 4.3	-4.4 millimeters Standard Deviation 3.8

PRIMARY outcome

Timeframe: At least 6 months postoperative

Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion.

Outcome measures

Outcome measures
Measure	Journey II Bi-Cruciate Stabilized n=25 Participants Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected Journey II Bi-Cruciate Stabilized TKA: Total Knee Arthroplasty System	Journey II Cruciate Retaining n=25 Participants Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained) Journey II Cruciate Retaining TKA: Total Knee Arthroplasty System	Journey II Bi-Cruciate Retaining n=10 Participants Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained Journey II Bi-Cruciate Retaining TKA: Total Knee Arthroplasty System
Lateral AP Translations, in mm	-12.5 millimeters Standard Deviation 5.0	-4.7 millimeters Standard Deviation 6.2	-9.4 millimeters Standard Deviation 6.1

PRIMARY outcome

Timeframe: At least 6 months postoperative

Maximum weight-bearing flexion, in degrees, during Deep Knee Bend Activity. Maximum flexion indicated how far a participant can bend their knee during a DKB. A larger number indicates greater flexion, i.e. more bending.

Outcome measures

Outcome measures
Measure	Journey II Bi-Cruciate Stabilized n=25 Participants Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected Journey II Bi-Cruciate Stabilized TKA: Total Knee Arthroplasty System	Journey II Cruciate Retaining n=25 Participants Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained) Journey II Cruciate Retaining TKA: Total Knee Arthroplasty System	Journey II Bi-Cruciate Retaining n=10 Participants Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained Journey II Bi-Cruciate Retaining TKA: Total Knee Arthroplasty System
Maximum Flexion, in Degrees	108 degrees Standard Deviation 13	121 degrees Standard Deviation 6	105 degrees Standard Deviation 13

PRIMARY outcome

Timeframe: At least 6 months postoperative

Axial Rotation, in degrees, during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their squat activity. A positive number indicates external femorotibial axial rotation from full extension to maximum flexion, and a negative number indicates internal femorotibial axial rotation from full extension to maximum flexion.

Outcome measures

Outcome measures
Measure	Journey II Bi-Cruciate Stabilized n=25 Participants Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected Journey II Bi-Cruciate Stabilized TKA: Total Knee Arthroplasty System	Journey II Cruciate Retaining n=25 Participants Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained) Journey II Cruciate Retaining TKA: Total Knee Arthroplasty System	Journey II Bi-Cruciate Retaining n=10 Participants Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained Journey II Bi-Cruciate Retaining TKA: Total Knee Arthroplasty System
Axial Rotation, in Degrees	7.1 degrees Standard Deviation 4.2	5.6 degrees Standard Deviation 5.7	6.0 degrees Standard Deviation 7.0

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: 865-974-9376

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place