Trial Outcomes & Findings for Optimized Loading Response by JOURNEY II BCS Knee Increases Daily Physical Activity and Functions (NCT NCT02335710)
NCT ID: NCT02335710
Last Updated: 2019-10-21
Results Overview
Anterior Posterior (AP) translations of medial femoral condyles during DKB Anterior Posterior (AP) translations of lateral femoral condyles during DKB
Recruitment status
COMPLETED
Target enrollment
50 participants
Primary outcome timeframe
3 months post-operative
Results posted on
2019-10-21
Participant Flow
Participant milestones
| Measure |
Smith & Nephew Journey II BCS TKA
Subjects must be implanted with a Smith \& Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA
|
Normal Knee
Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
10
|
|
Overall Study
COMPLETED
|
40
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimized Loading Response by JOURNEY II BCS Knee Increases Daily Physical Activity and Functions
Baseline characteristics by cohort
| Measure |
Smith & Nephew Journey II BCS TKA
n=40 Participants
Subjects must be implanted with a Smith \& Nephew Journey II bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) implanted by Dr. Harold Cates
Journey II BCS TKA
|
Normal Knee
n=10 Participants
Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Age, Continuous
|
69.76 years
STANDARD_DEVIATION 8.30 • n=99 Participants
|
57.44 years
STANDARD_DEVIATION 7.15 • n=107 Participants
|
67.29 years
STANDARD_DEVIATION 9.43 • n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months post-operativeAnterior Posterior (AP) translations of medial femoral condyles during DKB Anterior Posterior (AP) translations of lateral femoral condyles during DKB
Outcome measures
| Measure |
Smith & Nephew Journey II BCS TKA
n=40 Participants
Subjects must be implanted with a Smith \& Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA
|
Normal Knee
n=10 Participants
Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
|
|---|---|---|
|
Kinematics Translations During Deep Knee Bend (DKB) Activity
AP trans lateral femoral condyles 0-90 degrees
|
-10.11 mm
Standard Deviation 4.80
|
-13.15 mm
Standard Deviation 4.78
|
|
Kinematics Translations During Deep Knee Bend (DKB) Activity
AP trans medial femoral condyles 0-90 degrees
|
-5.15 mm
Standard Deviation 2.51
|
-4.93 mm
Standard Deviation 1.78
|
PRIMARY outcome
Timeframe: 3 months post-operativeMaximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB
Outcome measures
| Measure |
Smith & Nephew Journey II BCS TKA
n=40 Participants
Subjects must be implanted with a Smith \& Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA
|
Normal Knee
n=10 Participants
Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
|
|---|---|---|
|
Kinematics During Deep Knee Bend (DKB) Activity
Max weight-bearing flexion deep knee bend
|
95.6 degrees
Standard Deviation 20.5
|
143.6 degrees
Standard Deviation 10.5
|
|
Kinematics During Deep Knee Bend (DKB) Activity
AR of the femur 0-90 degrees
|
6.23 degrees
Standard Deviation 4.44
|
17.88 degrees
Standard Deviation 5.57
|
PRIMARY outcome
Timeframe: 3 months post-operativeAnterior Posterior (AP) translations of lateral femoral condyles during squat to stand (S2S) activity Anterior Posterior (AP) translations of medial femoral condyles during S2S
Outcome measures
| Measure |
Smith & Nephew Journey II BCS TKA
n=40 Participants
Subjects must be implanted with a Smith \& Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA
|
Normal Knee
n=10 Participants
Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
|
|---|---|---|
|
Kinematics Translations During Squat to Stand (S2S) Activity
AP trans of lateral femoral condyle 90-0 degrees
|
11.82 mm
Standard Deviation 4.68
|
11.30 mm
Standard Deviation 4.66
|
|
Kinematics Translations During Squat to Stand (S2S) Activity
AP trans of medial femoral condyle 90-0 degrees
|
5.49 mm
Standard Deviation 2.25
|
4.37 mm
Standard Deviation 2.12
|
PRIMARY outcome
Timeframe: 3 months post-operativeMaximum weight-bearing flexion during squat to stand (S2S) activity Axial Rotation (AR) of the femur during S2S
Outcome measures
| Measure |
Smith & Nephew Journey II BCS TKA
n=40 Participants
Subjects must be implanted with a Smith \& Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA
|
Normal Knee
n=10 Participants
Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
|
|---|---|---|
|
Kinematics During Squat to Stand (S2S) Activity
|
-7.78 degrees
Standard Deviation 4.92
|
-15.31 degrees
Standard Deviation 6.21
|
PRIMARY outcome
Timeframe: 3 months post-operativeAP Translations of the Medial and Lateral Femoral Condyles During Ramp Up activity
Outcome measures
| Measure |
Smith & Nephew Journey II BCS TKA
n=40 Participants
Subjects must be implanted with a Smith \& Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA
|
Normal Knee
n=10 Participants
Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
|
|---|---|---|
|
Kinematics Translations During Ramp up Activity
Medial Anterior Posterior Translation 0% to 33%
|
0.81 mm
Standard Deviation 3.05
|
-1.51 mm
Standard Deviation 1.62
|
|
Kinematics Translations During Ramp up Activity
Medial Anterior Posterior Translation 33% to 66%
|
1.21 mm
Standard Deviation 2.69
|
1.20 mm
Standard Deviation 1.15
|
|
Kinematics Translations During Ramp up Activity
Medial Anterior Posterior Translation 66% to 100%
|
-3.16 mm
Standard Deviation 3.83
|
0.63 mm
Standard Deviation 1.44
|
|
Kinematics Translations During Ramp up Activity
Lateral Anterior Posterior Translation 0-33%
|
0.40 mm
Standard Deviation 1.88
|
-2.72 mm
Standard Deviation 3.18
|
|
Kinematics Translations During Ramp up Activity
Lateral Anterior Posterior Translation 33%-66%
|
1.88 mm
Standard Deviation 3.50
|
3.43 mm
Standard Deviation 2.20
|
|
Kinematics Translations During Ramp up Activity
Lateral Anterior Posterior Translation 66%-100%
|
-4.39 mm
Standard Deviation 5.63
|
-2.24 mm
Standard Deviation 2.01
|
PRIMARY outcome
Timeframe: 3 months post-operativeAR of the femur during Ramp Up activity
Outcome measures
| Measure |
Smith & Nephew Journey II BCS TKA
n=40 Participants
Subjects must be implanted with a Smith \& Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA
|
Normal Knee
n=10 Participants
Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
|
|---|---|---|
|
Kinematics During Ramp up Activity
AR 0% to 33%
|
0.50 degrees
Standard Deviation 2.97
|
2.25 degrees
Standard Deviation 4.15
|
|
Kinematics During Ramp up Activity
AR 33% to 66%
|
-0.82 degrees
Standard Deviation 2.50
|
-3.64 degrees
Standard Deviation 3.13
|
|
Kinematics During Ramp up Activity
AR 66% to 100%
|
1.51 degrees
Standard Deviation 3.67
|
3.76 degrees
Standard Deviation 3.03
|
PRIMARY outcome
Timeframe: 3 months post-operativeAP Translations of the Medial and Lateral Femoral Condyles during Ramp down activity
Outcome measures
| Measure |
Smith & Nephew Journey II BCS TKA
n=40 Participants
Subjects must be implanted with a Smith \& Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA
|
Normal Knee
n=10 Participants
Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
|
|---|---|---|
|
Kinematics Translations During Ramp Down Activity
Medial Anterior Posterior Translation 0% to 33%
|
-0.56 mm
Standard Deviation 2.93
|
-1.20 mm
Standard Deviation 1.39
|
|
Kinematics Translations During Ramp Down Activity
Medial Anterior Posterior Translation 33% to 66%
|
-1.34 mm
Standard Deviation 1.94
|
0.08 mm
Standard Deviation 1.21
|
|
Kinematics Translations During Ramp Down Activity
Medial Anterior Posterior Translation 66% to 100%
|
-0.35 mm
Standard Deviation 3.33
|
0.20 mm
Standard Deviation 2.25
|
|
Kinematics Translations During Ramp Down Activity
Lateral Anterior Posterior Translation 0-33%
|
-1.45 mm
Standard Deviation 4.52
|
-2.59 mm
Standard Deviation 3.56
|
|
Kinematics Translations During Ramp Down Activity
Lateral Anterior Posterior Translation 33%-66%
|
-2.57 mm
Standard Deviation 3.15
|
-1.85 mm
Standard Deviation 2.38
|
|
Kinematics Translations During Ramp Down Activity
Lateral Anterior Posterior Translation 66%-100%
|
-0.24 mm
Standard Deviation 4.90
|
1.36 mm
Standard Deviation 2.46
|
PRIMARY outcome
Timeframe: 3 months post-operativeAR of the femur during ramp down activity
Outcome measures
| Measure |
Smith & Nephew Journey II BCS TKA
n=40 Participants
Subjects must be implanted with a Smith \& Nephew Journey II BCS TKA implanted by Dr. Harold Cates
Journey II BCS TKA
|
Normal Knee
n=10 Participants
Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
|
|---|---|---|
|
Kinematics During Ramp Down Activity
AR 0% to 33%
|
1.10 degrees
Standard Deviation 3.18
|
3.30 degrees
Standard Deviation 5.15
|
|
Kinematics During Ramp Down Activity
AR 33% to 66%
|
1.54 degrees
Standard Deviation 3.39
|
3.04 degrees
Standard Deviation 3.35
|
|
Kinematics During Ramp Down Activity
AR 66% to 100%
|
-0.15 degrees
Standard Deviation 3.30
|
-1.81 degrees
Standard Deviation 3.01
|
Adverse Events
Smith & Nephew Journey II BCS TKA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Knee
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place