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The purpose of this study is to compare the effect of post-operative ROM between Flex IM rod and Rigid IM rod, to collect bone morphology of Japanese lower extremity and to research the incidence of overhung with Flex IM rod.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flex IM Rod | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flex IM rod | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum postoperative flexion angle | 48 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life as assessed by36-Item Short-Form Health Survey (SF-36)questionnaire | 4 weeks , 24 weeks and 48 weeks after surgery | |
| Japanese Knee Osteoarthritis Measure(JKOM) | 4 weeks , 24 weeks and 48 weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasuyuki Inatsugu | Stryker Japan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hyogo College of Medicine Hospital | Nishinomiya | Hyōgo | 663-8501 | Japan | ||
| Saiseikai Yokohama East Hospital |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Knee Society Scale (KSS) | 4 weeks , 24 weeks and 48 weeks after surgery |
| Range of Motion (ROM) | 4 weeks , 24 weeks and 48 weeks after surgery |
| Yokohama |
| Kanagawa |
| 230-8765 |
| Japan |
| Osaka General Medical Center | Osaka | 558-8558 | Japan |
| D012216 |
| Rheumatic Diseases |