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PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed
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| Name | Class |
|---|---|
| Depuy, Inc. | INDUSTRY |
This study is designed to compare prospectively, in a randomized Level 1 evidence fashion, the clinical, functional, and radiographic results of a modular polished tibial (MPT) tray with a moderately cross-linked polyethylene (XLK) insert to an all-polyethylene tibial (APT) design with GVF polyethylene. Comparing these two designs will afford us information in the following areas:
Answering these questions will allow surgeons to use both designs appropriately in different demand populations.
This study is designed to address the questions of whether an MPT/XLK design offers improvement in wear characteristics, Knee Society scores, KOOS, WOMAC, SF-36, or radiographic measures, over an APT design. The investigator's primary hypothesis is that there will be no difference in these outcome measures at a minimum two year follow-up. A secondary hypothesis based on the long-term follow-up of this group, up to twenty years, is that there will be no difference in implant survival.
Summary is detailed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modular Metal Tibial Baseplate | Experimental | Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA |
|
| All Polyethylene Tibial Baseplate | Active Comparator | Patients who were randomized to receive the nonmodular APT/GVF TKA design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKA surgery with modular polished tibial baseplate/XLK design | Procedure | TKA surgery with modular polished tibial baseplate/XLK design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36) | Patient recorded outcome measures as noted | 2 year follow-up intervals up to 20 years |
| Measure | Description | Time Frame |
|---|---|---|
| Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene | Wear characteristics as above | 2 year followup intervals to 20 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terence J Gioe, M.D. | Minneapolis VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VAMC | Minneapolis | Minnesota | 55417 | United States |
PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed
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| ID | Title | Description |
|---|---|---|
| FG000 | Modular Metal Tibial Baseplate | Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA TKA surgery with modular polished tibial baseplate/XLK design: TKA surgery with modular polished tibial baseplate/XLK design P.F.C.® Sigma Knee System: P.F.C.® Sigma Knee System with modular XLK poly |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| TKA surgery with the nonmodular APT/GVF design | Procedure | TKA surgery with the nonmodular APT/GVF design |
|
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| P.F.C.® Sigma Knee System | Device | P.F.C.® Sigma Knee System with modular XLK poly |
|
| P.F.C.® Sigma Knee System | Device | P.F.C. ® Sigma Knee System with an all-poly GVF tibia |
|
| All Polyethylene Tibial Baseplate |
Patients who were randomized to receive the nonmodular APT/GVF TKA design. TKA surgery with the nonmodular APT/GVF design: TKA surgery with the nonmodular APT/GVF design P.F.C.® Sigma Knee System: P.F.C. ® Sigma Knee System with an all-poly GVF tibia |
| COMPLETED |
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| NOT COMPLETED |
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PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed
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| ID | Title | Description |
|---|---|---|
| BG000 | Modular Metal Tibial Baseplate | Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA TKA surgery with modular polished tibial baseplate/XLK design: TKA surgery with modular polished tibial baseplate/XLK design P.F.C.® Sigma Knee System: P.F.C.® Sigma Knee System with modular XLK poly |
| BG001 | All Polyethylene Tibial Baseplate | Patients who were randomized to receive the nonmodular APT/GVF TKA design. TKA surgery with the nonmodular APT/GVF design: TKA surgery with the nonmodular APT/GVF design P.F.C.® Sigma Knee System: P.F.C. ® Sigma Knee System with an all-poly GVF tibia |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
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| Age, Continuous | |||||||||||||||||||||||||||||||
| Sex: Female, Male |
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| Ethnicity (NIH/OMB) |
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| Race (NIH/OMB) |
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| Region of Enrollment | participants |
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| PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. |
| 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 | Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36) | Patient recorded outcome measures as noted | PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed | Posted | 2 year follow-up intervals up to 20 years |
|
| ||||||||||||||||||||||
| Secondary | Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene | Wear characteristics as above | PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed | Posted | 2 year followup intervals to 20 years |
|
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PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed
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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 | Modular Metal Tibial Baseplate | Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA TKA surgery with modular polished tibial baseplate/XLK design: TKA surgery with modular polished tibial baseplate/XLK design P.F.C.® Sigma Knee System: P.F.C.® Sigma Knee System with modular XLK poly | 0 | 0 | 0 | 0 | ||
| EG001 | All Polyethylene Tibial Baseplate | Patients who were randomized to receive the nonmodular APT/GVF TKA design. TKA surgery with the nonmodular APT/GVF design: TKA surgery with the nonmodular APT/GVF design P.F.C.® Sigma Knee System: P.F.C. ® Sigma Knee System with an all-poly GVF tibia | 0 | 0 | 0 | 0 |
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PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terence Gioe M.D. | Minneapolis VAMC | 612-467-1780 | tjgioe@gmail.com |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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