Osteoarthritis, Knee
Conditions
Keywords
knee arthritis, total knee arthroplasty, total knee replacement, metal backed tibial component, all-polyethylene tibia, modular polished tibial baseplate
Brief summary
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: 1. Does a MPT/XLK design have improved wear characteristics over a nonmodular APT/GVF design? 2. Is there a clear clinical advantage to the MPT/XLK design in certain patient populations that justify its use over the APT/GVF design? 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.
Detailed description
Summary is detailed
Interventions
PROCEDURETKA surgery with modular polished tibial baseplate/XLK design
TKA surgery with modular polished tibial baseplate/XLK design
PROCEDURETKA surgery with the nonmodular APT/GVF design
TKA surgery with the nonmodular APT/GVF design
DEVICEP.F.C.® Sigma Knee System
P.F.C.® Sigma Knee System with modular XLK poly
Sponsors
Depuy, Inc.
Minneapolis Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* generally accepted clinical and radiographic criteria for total knee arthroplasty
Exclusion criteria
* Significant angular or bony deformity necessitating structural bone grafting or more extensive modular designs will be excluded at the discretion of the principle investigator * Routine contraindications to TKA (active sepsis, Charcot arthropathy) * Patients whose mental function preclude them from responding to our standard questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36) | 2 year follow-up intervals up to 20 years | Patient recorded outcome measures as noted |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene | 2 year followup intervals to 20 years | Wear characteristics as above |
Countries
United States
Participant flow
Pre-assignment details
PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| 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 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36)
Patient recorded outcome measures as noted
Time frame: 2 year follow-up intervals up to 20 years
Population: PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed
Secondary
Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene
Wear characteristics as above
Time frame: 2 year followup intervals to 20 years
Population: PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed