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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 |
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This study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will afford the investigators information in the following areas:
Answering these questions will allow surgeons to use RP designs appropriately in different demand populations.
This study was designed to address the questions of whether an RP design offers improvement in ROM, Knee Society scores, Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) scores, selected Medical Outcomes Short-Form Health Survey Short Form-36 (SF-36) scores or radiographic measures, over an APT design. The investigators' primary hypothesis was that there would be no difference in these outcome measures at a minimum two year followup. A secondary hypothesis based on the anticipated long-term followup of this group was that there would be no difference in implant survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rotating-platform design TKA | Active Comparator | patients who were randomized to receive the rotating platform mobile-bearing TKA design |
|
| all-polyethylene tibia design TKA | Active Comparator | patients who were randomized to receive the all-polyethylene tibial component design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKA surgery with the rotating platform mobile-bearing knee design | Procedure | Depuy Sigma RP rotating platform design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Postoperative Range of Motion (ROM) at 2 Years | range of motion of the knee postoperatively at 2 years | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival of the Implants to Subject Death or Implant Removal | 10 or more years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terence J Gioe, M.D. | Minneapolis VAMC, Dept. of Orthopaedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VAMC | Minneapolis | Minnesota | 55417 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19723986 | Result | Gioe TJ, Glynn J, Sembrano J, Suthers K, Santos ER, Singh J. Mobile and fixed-bearing (all-polyethylene tibial component) total knee arthroplasty designs. A prospective randomized trial. J Bone Joint Surg Am. 2009 Sep;91(9):2104-12. doi: 10.2106/JBJS.H.01442. |
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Patients that were recruited but not enrolled either failed the inclusion criteria or elected not to participate
October 1, 2001 to January 1, 2007 recruitment period from the Minneapolis VAMC Orthopaedic Clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotating-platform Design Total Knee Arthroplasty (TKA) | patients who were randomized to receive the rotating platform mobile-bearing TKA design |
| FG001 | All-polyethylene Tibia Design Total Knee Arthroplasty (TKA) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| TKA surgery with the all-polyethylene tibia knee design | Procedure | Depuy Sigma fixed-bearing design with all-polyethylene tibia |
|
patients who were randomized to receive the all-polyethylene tibial component design
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotating-platform Design Total Knee Arthroplasty (TKA) | patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design |
| BG001 | All-polyethylene Tibia Design Total Knee Arthroplasty (TKA) | patients who were randomized to receive the all-polyethylene tibial component design |
| 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 | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| range of motion of knee | Mean | Standard Deviation | degrees |
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| 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 | Knee Postoperative Range of Motion (ROM) at 2 Years | range of motion of the knee postoperatively at 2 years | Posted | Mean | Standard Deviation | degrees | 2 years |
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| Secondary | Survival of the Implants to Subject Death or Implant Removal | PI/study coordinator retired due to personal family health matters and study sponsor withdrew funding. Study was terminated and no data was collected or analyzed from any participant for this outcome measure. | Posted | 10 or more years |
|
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2 Years
PI/study coordinator retired due to personal family health matters and study sponsor then withdrew funding. Study terminated and no data was collected or analyzed from any participant.
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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 | Rotating-platform Design Total Knee Arthroplasty (TKA) | patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design | 0 | 200 | 0 | 200 | ||
| EG001 | All-polyethylene Tibia Design Total Knee Arthroplasty (TKA) | patients who were randomized to receive the all-polyethylene tibial component design | 0 | 200 | 0 | 200 |
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PI/study coordinator retired due to personal family health matters and study sponsor then withdrew funding. Study terminated and no data was collected or analyzed from any participant.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terence J. Gioe, M.D. | PI/study coordinator retired due to personal family health matters and study sponsor then withdrew funding. Study terminated and no data was collected or analyzed from any participant. | 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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| >=65 years |
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| Male |
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