Osteoarthritis, Knee
Conditions
Keywords
navigation system, palm-sized, total knee arthroplasty
Brief summary
Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments
Detailed description
Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments.
Interventions
DEVICEKneeAlign 2
Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Knee (either unilateral or bilateral) Osteoarthritis (varus deformity only) * Subjects willing to return for follow-up evaluations
Exclusion criteria
* Knee degenerative diseases other than Knee Osteoarthritis (such as necrosis / Rheumatoid Arthritis) * Severe OA deformation (FTA: \>185 degrees or \<175 degrees) * Active Infection (or within 6 weeks after infection) * Sepsis * Osteomyelitis * Any type of implant is inserted in the affected side of lower extremity * Hip disease on the affected side * Uncooperative patient or patient with neurologic disorders who are incapable of following directions * diagnosed Osteoporosis or Osteomalacia * Metabolic disorders which may impair bone formation * Distant foci of infections which may spread to the implant site * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * Vascular insufficiency, muscular atrophy or neuromuscular disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia | Postoperative 6 months | Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold | Postoperative 6 months | Deviation of tibial posterior slope angle from preoperative planned angle (within 2 degrees) |
| Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold | Postoperative 6 months | Deviation of femoral valus/valgus angle from preoperative planned angle (within 2 degrees) |
| Number of Participants With Adverse Events and/or Adverse Device Effects | Intra-operative and Post-operative 6 months | Number of participants, who experience adverse events and/or adverse device effects |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vanguard With KneeAlign 2 Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2.
KneeAlign 2: Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation. | 50 |
| Vanguard Without KneeAlign 2 Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Poor X-ray quality for measurement | 4 | 5 |
Baseline characteristics
| Characteristic | Vanguard With KneeAlign 2 | Vanguard Without KneeAlign 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 49 Participants | 46 Participants | 95 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 5 Participants |
| Age, Continuous | 75.8 years STANDARD_DEVIATION 5.2 | 74.0 years STANDARD_DEVIATION 6.6 | 74.9 years STANDARD_DEVIATION 6 |
| Body Mass Index | 26.3 kg/m^2 STANDARD_DEVIATION 4.2 | 27.3 kg/m^2 STANDARD_DEVIATION 4.3 | 26.8 kg/m^2 STANDARD_DEVIATION 4.3 |
| EQ-5D-3L | 0.553 point STANDARD_DEVIATION 0.117 | 0.582 point STANDARD_DEVIATION 0.091 | 0.568 point STANDARD_DEVIATION 0.105 |
| KSS-Function Score | 33.5 point STANDARD_DEVIATION 16.5 | 43.6 point STANDARD_DEVIATION 18.4 | 38.3 point STANDARD_DEVIATION 18 |
| KSS-Objective Score | 37.4 point STANDARD_DEVIATION 19.1 | 35.9 point STANDARD_DEVIATION 19.3 | 36.6 point STANDARD_DEVIATION 19.1 |
| KSS-Patient Expectation | 9.1 point STANDARD_DEVIATION 2.1 | 9.6 point STANDARD_DEVIATION 2.6 | 9.3 point STANDARD_DEVIATION 2.4 |
| KSS-Patient Satisfaction | 11.2 point STANDARD_DEVIATION 6.1 | 13.1 point STANDARD_DEVIATION 6 | 12.1 point STANDARD_DEVIATION 6.1 |
| Oxford Knee Score | 20.7 point STANDARD_DEVIATION 8 | 24.0 point STANDARD_DEVIATION 7.9 | 22.4 point STANDARD_DEVIATION 8.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 50 Participants | 50 Participants | 100 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 39 Participants | 40 Participants | 79 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 1 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia
Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups.
Time frame: Postoperative 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vanguard With KneeAlign 2 | Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia | within 2 degrees (success) | 41 Participants |
| Vanguard With KneeAlign 2 | Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia | outlier (failure) | 4 Participants |
| Vanguard Without KneeAlign 2 | Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia | within 2 degrees (success) | 31 Participants |
| Vanguard Without KneeAlign 2 | Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia | outlier (failure) | 14 Participants |
Secondary
Number of Participants With Adverse Events and/or Adverse Device Effects
Number of participants, who experience adverse events and/or adverse device effects
Time frame: Intra-operative and Post-operative 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vanguard With KneeAlign 2 | Number of Participants With Adverse Events and/or Adverse Device Effects | 1 Participants |
| Vanguard Without KneeAlign 2 | Number of Participants With Adverse Events and/or Adverse Device Effects | 0 Participants |
Secondary
Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold
Deviation of femoral valus/valgus angle from preoperative planned angle (within 2 degrees)
Time frame: Postoperative 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vanguard With KneeAlign 2 | Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold | within 2 degrees (success) | 35 Participants |
| Vanguard With KneeAlign 2 | Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold | outlier (failure) | 10 Participants |
| Vanguard Without KneeAlign 2 | Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold | within 2 degrees (success) | 28 Participants |
| Vanguard Without KneeAlign 2 | Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold | outlier (failure) | 17 Participants |
Secondary
Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold
Deviation of tibial posterior slope angle from preoperative planned angle (within 2 degrees)
Time frame: Postoperative 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vanguard With KneeAlign 2 | Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold | within 2 degrees (success) | 26 Participants |
| Vanguard With KneeAlign 2 | Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold | outlier (failure) | 19 Participants |
| Vanguard Without KneeAlign 2 | Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold | within 2 degrees (success) | 27 Participants |
| Vanguard Without KneeAlign 2 | Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold | outlier (failure) | 18 Participants |