Trial Outcomes & Findings for Total Knee Replacement Component Alignment Using Manual Versus Custom Instrumentation (NCT NCT02579174)
NCT ID: NCT02579174
Last Updated: 2022-11-15
Results Overview
Measured HKA change from pre-operative EOS longstanding X-ray to post-operative EOS at 6wks. comparing groups receiving manual instrumentation versus custom instrumentation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
Pre-operative, 6 wks. post-op
Results posted on
2022-11-15
Participant Flow
Participant milestones
| Measure |
Manual (Tibia) and Manual (Femur)
Knee replacement with Medacta GMK Sphere implants using manual instrumentation for both the tibia component and the femur component
Medacta GMK Sphere
|
Manual (Tibia) and Custom (Femur)
Knee replacement with Medacta GMK Sphere implants using manual instrumentation for the tibia component and custom instrumentation for the femur component
Medacta GMK Sphere
|
Custom (Tibia) and Custom (Femur)
Knee replacement with Medacta GMK Sphere implants using custom instrumentation for both the tibia component and the femur component
Medacta GMK Sphere
|
Custom (Tibia) and Manual (Femur)
Knee replacement with Medacta GMK Sphere implants using custom instrumentation for the tibia component and manual instrumentation for the femur component
Medacta GMK Sphere
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
28
|
25
|
|
Overall Study
COMPLETED
|
18
|
16
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
11
|
14
|
12
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Manual (Tibia) and Manual (Femur)
n=18 Participants
Knee replacement with Medacta GMK Sphere implants using manual instrumentation for both the tibia component and the femur component
Medacta GMK Sphere
|
Manual (Tibia) and Custom (Femur)
n=16 Participants
Knee replacement with Medacta GMK Sphere implants using manual instrumentation for the tibia component and custom instrumentation for the femur component
Medacta GMK Sphere
|
Custom (Tibia) and Custom (Femur)
n=16 Participants
Knee replacement with Medacta GMK Sphere implants using custom instrumentation for both the tibia component and the femur component
Medacta GMK Sphere
|
Custom (Tibia) and Manual (Femur)
n=16 Participants
Knee replacement with Medacta GMK Sphere implants using custom instrumentation for the tibia component and manual instrumentation for the femur component
Medacta GMK Sphere
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=66 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=18 Participants
|
5 Participants
n=16 Participants
|
1 Participants
n=16 Participants
|
5 Participants
n=16 Participants
|
11 Participants
n=66 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=18 Participants
|
11 Participants
n=16 Participants
|
15 Participants
n=16 Participants
|
11 Participants
n=16 Participants
|
55 Participants
n=66 Participants
|
|
Age, Continuous
|
68.39 years
STANDARD_DEVIATION 9.91 • n=18 Participants
|
63.37 years
STANDARD_DEVIATION 5.25 • n=16 Participants
|
68.77 years
STANDARD_DEVIATION 7.22 • n=16 Participants
|
67.05 years
STANDARD_DEVIATION 8.67 • n=16 Participants
|
65.82 years
STANDARD_DEVIATION 8.17 • n=66 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=18 Participants
|
9 Participants
n=16 Participants
|
10 Participants
n=16 Participants
|
12 Participants
n=16 Participants
|
38 Participants
n=66 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=18 Participants
|
7 Participants
n=16 Participants
|
6 Participants
n=16 Participants
|
4 Participants
n=16 Participants
|
28 Participants
n=66 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Pre-operative, 6 wks. post-opPopulation: Sub group analysis of only participants who received both manual or both custom instrumentations.
Measured HKA change from pre-operative EOS longstanding X-ray to post-operative EOS at 6wks. comparing groups receiving manual instrumentation versus custom instrumentation
Outcome measures
| Measure |
Total Component Manual Instrumentation
n=18 Participants
Participants who received manual instrumentation guides for both the tibial and femoral component of the total knee implant; study group Manual-Manual
|
Total Component Custom Instrumentation
n=16 Participants
Participants who received custom instrumentation guides for both the tibial and femoral component of the total knee implant; study group Custom-Custom
|
|---|---|---|
|
Post-Operative Hip-Knee-Angle (HKA)
|
2.14 Degrees
Standard Deviation 1.79
|
3.06 Degrees
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: Pre-operative, 6 wks. post-opPopulation: Analysis combining groups receiving manual vs custom tibial instrumentation.
Measured change between pre-operative planning report \& post-operative EOS longstanding radiograph in varus deformity of the operative joint
Outcome measures
| Measure |
Total Component Manual Instrumentation
n=34 Participants
Participants who received manual instrumentation guides for both the tibial and femoral component of the total knee implant; study group Manual-Manual
|
Total Component Custom Instrumentation
n=32 Participants
Participants who received custom instrumentation guides for both the tibial and femoral component of the total knee implant; study group Custom-Custom
|
|---|---|---|
|
Tibial Varus Deformity
|
1.00 Degrees
Standard Deviation 0.79
|
1.38 Degrees
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Pre-operative, 6 wks. post-opPopulation: Combined analysis of participants who received manual vs custom femoral instrumentation.
Measured change between pre-operative planning report \& post-operative EOS longstanding radiograph in varus deformity of the operative joint
Outcome measures
| Measure |
Total Component Manual Instrumentation
n=34 Participants
Participants who received manual instrumentation guides for both the tibial and femoral component of the total knee implant; study group Manual-Manual
|
Total Component Custom Instrumentation
n=32 Participants
Participants who received custom instrumentation guides for both the tibial and femoral component of the total knee implant; study group Custom-Custom
|
|---|---|---|
|
Femoral Valgus Deformity
|
1.53 Degrees
Standard Deviation 1.22
|
1.76 Degrees
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Pre-Operative - 6 wk. Post-OperativePopulation: Combined analysis of participants who received manual vs custom tibial instrumentation
Deviation from pre-operative planning template \& 6 wk. post-operative longstanding EOS radiograph
Outcome measures
| Measure |
Total Component Manual Instrumentation
n=34 Participants
Participants who received manual instrumentation guides for both the tibial and femoral component of the total knee implant; study group Manual-Manual
|
Total Component Custom Instrumentation
n=32 Participants
Participants who received custom instrumentation guides for both the tibial and femoral component of the total knee implant; study group Custom-Custom
|
|---|---|---|
|
Tibial Posterior Slope (Mean Deviation)
|
2.70 Degrees
Standard Deviation 1.56
|
2.43 Degrees
Standard Deviation 1.78
|
Adverse Events
Manual (Tibia) and Manual (Femur)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Manual (Tibia) and Custom (Femur)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Custom (Tibia) and Custom (Femur)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Custom (Tibia) and Manual (Femur)
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