Osteoarthritis of Knee
Conditions
Keywords
Total knee arthroplasty, Mobile bearing, Fixed bearing, Range of motion, Knee Society Score
Brief summary
The purpose of this study is to compare the clinical and radiological outcomes of mobile-bearing with that of fixed-bearing in total knee arthroplasty.
Detailed description
Double blind, randomized prospective study Mobile or fixed bearing of the same company * Mobile bearing group : group M * Fixed bearing group : group F Inclusion criteria * patients expected primary total knee arthroplasty without severe deformity Clinical outcomes * Range of motion * Complication * Scorings * KSS, KSFS, HSS score, WOMAC score, Oxford score, SF-36 Radiological outcomes * Alignment angles in knee * Positions of femoral and tibial components * Position of patella * Radiolucency
Interventions
DEVICEMobile bearing
Mobile bearing in total knee arthroplasty
DEVICEFixed bearing
Fixed bearing in total knee arthroplasty
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* primary total knee arthroplasty
Exclusion criteria
* infection * severe deformity in knee * revision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rotational Angle Between Femur and Tibia | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Knee Society Score | 6 months |
Countries
South Korea
Participant flow
Recruitment details
Recruitment was started from Sep 2005 to Aug 2006 in medical clinic and randomly allocated into two groups.
Participants by arm
| Arm | Count |
|---|---|
| Mobile Bearing Mobile bearing vs Fixed bearing | 40 |
| Fixed Bearing Mobile bearing vs Fixed bearing | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Fixed Bearing | Mobile Bearing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 31 Participants | 54 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 9 Participants | 26 Participants |
| Age Continuous | 66.08 years STANDARD_DEVIATION 5.55 | 68.36 years STANDARD_DEVIATION 5.61 | 67.24 years STANDARD_DEVIATION 5.81 |
| Region of Enrollment Korea, Republic of | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 39 Participants | 38 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Rotational Angle Between Femur and Tibia
Time frame: 2 weeks
Population: The rotational angle between the femur and tibia was collected by postoperative CT and asssessed between the transepicondylar angle in the femur and the vertical line of the AP axis of the tibia(the line between the insertion of the PCL and the medial 1/3 point of the tibial tuberosity).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile Bearing | Rotational Angle Between Femur and Tibia | -0.48 degree | Standard Deviation 2.18 |
| Fixed Bearing | Rotational Angle Between Femur and Tibia | -0.66 degree | Standard Deviation 1.52 |
Secondary
Knee Society Score
Time frame: 6 months