Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SNUHOSK09MBFB | Other Identifier | Seoul national university hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Double blind, randomized prospective study Mobile or fixed bearing of the same company
Inclusion criteria
Clinical outcomes
Range of motion
Complication
Scorings
Radiological outcomes
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile bearing | Active Comparator | Mobile bearing type between polyethylene insert and tibial component MB type will be randomly used in total knee arthroplasty |
|
| Fixed bearing | Active Comparator | Fixed bearing type between polyethylene insert and tibial component FB type will be randomly used in total knee arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile bearing | Device | Mobile bearing in total knee arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rotational Angle Between Femur and Tibia | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Myung Chul Lee, M.D., Ph. D. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Seoul | South Korea |
Not provided
Recruitment was started from Sep 2005 to Aug 2006 in medical clinic and randomly allocated into two groups.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mobile Bearing | Mobile bearing vs Fixed bearing |
| FG001 | Fixed Bearing | Mobile bearing vs Fixed bearing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Bearing | Mobile bearing vs Fixed bearing |
| BG001 | Fixed Bearing | Mobile bearing vs Fixed bearing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rotational Angle Between Femur and Tibia | 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). | Posted | Mean | Standard Deviation | degree | 2 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mobile Bearing | Mobile bearing vs Fixed bearing |
Not provided
Not provided
First, our study population is composed of elderly patients with large female dominance
Second concern was inherent errors in making the measurements in this kind of study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dongwook Kim | Seoul National University Hospital | 821067395311 | daljookim@gmail.com |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fixed bearing | Device | Fixed bearing in total knee arthroplasty |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Knee Society Score | Not Posted | 6 months |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Fixed Bearing | Mobile bearing vs Fixed bearing | 0 | 40 | 0 | 40 |
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |