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The purpose of this study is to explore the benefit of X3 polyethlene inserts with larger diameter heads used in the Japanese population. Range of Motion (ROM) and lift-off distance for both 28mm, 32mm and 36mm in patients will be examined intraoperatively by using the Stryker computerized tomography (CT) based Navigation system. Another aspect of this study is to observe wear resistance performance of X3 over historical liner existing highly crosslinked polyethylene.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trident Acetabular X3 Insert | Other | 28mm, 32mm and 36mm liner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trident Acetabular X3 Insert | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion(ROM) (Degree) | Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation. | Intraoperative |
| Lift Off Distance in Dislocation Maneuver(mm) | Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Wear Rate(%) | Retrospective comparison of the wear amount over time between X3 liner and Crossfire insert. | 1 year, 2 years, 3 years and 5 years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya Kyoritsu Hospital | Nagoya | Aichi-ken | 454-0933 | Japan | ||
| Yokohama City University Hospital |
117 participants / 120 hips enrolled in study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trident Acetabular X3 Insert | Trident Acetabular X3 Insert 28mm, 32mm and 36mm liner |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | X3 Liner | X3 28mm, 32mm and 36mm liner Trident Acetabular X3 Insert |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Range of Motion(ROM) (Degree) | Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation. | Comparison between 28mm liner and 36mm line. Participants with available data : 119 hips in 117 participants. | Posted | Mean | Standard Deviation | Degree | Intraoperative | Hips | Hips |
|
|
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Adverse Events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | X3 Liner | X3 28mm, 32mm and 36mm liner Trident Acetabular X3 Insert |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yasuyuki Inatsugu, Associate manager of clinical affairs | Stryker Japan | 81 3 6894 8394 | yasuyuki.inatsugu@stryker.com |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| Yokohama |
| Kanagawa |
| 236-0004 |
| Japan |
| Kyowakai Hospital. | Suita | Osaka | 564-0001 | Japan |
| Osaka City General Hospital. | Osaka | 534-0021 | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hips |
|
|
| Primary | Lift Off Distance in Dislocation Maneuver(mm) | Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation. | participants with available data : 100 hips in 100 participants. | Posted | Mean | Standard Deviation | mm | Intraoperative | Hips | Hips |
|
|
|
| Secondary | Wear Rate(%) | Retrospective comparison of the wear amount over time between X3 liner and Crossfire insert. | Not Posted | 1 year, 2 years, 3 years and 5 years after surgery | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
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| Title | Measurements |
|---|---|
|