Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate long-term clinical and radiographic data between geometrically identical GVF and cross-linked polyethylene-bearing inserts in total knee arthroplasty.

Detailed Description
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In 1996, Gamma Vacuum Foil (GVF) polyethylene was introduced as the first polyethylene to be gamma irradiated and packaged in an inert environment. This polyethylene, with its patented process and packaging, continues to be the only barrier-packaged process that is impermeable to both Hydrogen (H2) and Oxygen (O2), and allows the polyethylene to recombine and cross-link in the package. Though the new moderately cross-linked polyethylene being evaluated in this protocol is comparable to GVF geometrically and mechanically, the P.F.C.® Sigma™ cross-linked polyethylene also has the added benefit of being completely oxidatively stable both on the shelf and in-vivo. The P.F.C. Sigma tibial tray component being assessed in this study is made of Cobalt Chrome (CoCr). The new CoCr tibial tray has the same design geometrically as the original titanium (Ti) tray, however, it features a highly polished top surface where it is joined to the polyethylene. This polished surface is designed to decrease the coefficient of friction between the polyethylene and the tray, thus minimizing backside wear. A comparative clinical study will be conducted to evaluate long-term clinical and radiographic data between geometrically identical cemented implants using GVF and crosslinked polyethylene tibial tray bearing inserts in Total Knee Arthroplasty (TKA) using the P.F.C. Sigma Total Knee System. Patients will be assigned to study treatment groups at random if they meet specific demographic and pathophysiologic criteria for cemented total knee arthroplasty. The anticipated duration of this investigation is a minimum six years, which includes a one-year enrollment phase. The specific aims of this study are as follows: Examine whether crosslinked polyethylene performs as well, if not better, than GVF polyethylene through standard clinical evaluations. Evaluate long-term survivorship rates. Report complications/adverse events. Report radiographic findings of geometrically identical implants.

Official Title
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Prospective, Comparative, Randomized Study of GVF Versus Cross-linked Polyethylene in Total Knee Arthroplasty

Conditions
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Osteoarthritis, Knee, Arthritis, Rheumatoid

Intervention / Treatment
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* Device: total knee arthroplasty
* Device: total knee arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis of the affected joint appropriate for Total Knee Arthroplasty. Diagnosis of any of the following: rheumatoid or other inflammatory arthritis, post-traumatic arthritis, juvenile rheumatoid arthritis. Radiographic evidence of sufficient sound bone stock to seat and support the prosthesis. Subject requires a primary total knee replacement and is considered to be suitable for the specific knee prosthesis identified in protocol. Subject has given consent to the transfer of his/her information to sponsor. Subject will be compliant with requirements of protocol by returning for follow-up visits. Exclusion Criteria: History of recent/active joint sepsis. Charcot neuropathy. Psycho-social disorders that would limit rehabilitation. Women who are pregnant or planning on being pregnant. Greater than 80 years of age at the time of surgery. Prior ipsilateral knee arthroplasty. Metabolic disorders of calcified tissues, such as Paget's disease. Severe diabetes mellitus that is not controlled by diet or oral agents. Require joint replacement due to immunodeficiency syndromes. Skeletal immaturity. Avascular necrosis of the affected knee. Chronic renal disease. Subjects involved in medical-legal or worker's compensation claims.

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GVF<br>Gamma Vacuum Foil polyethylene tibial insert | Device: total knee arthroplasty<br>* Gamma Vacuum Foil polyethylene tibial insert<br>|
| Active Comparator: P.F.C.<br>Cross-linked polyethylene tibial insert | Device: total knee arthroplasty<br>* cross-linked polyethylene tibial insert<br>* Other names: P.F.C. Sigma cross-linked bearing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship (Revision of Any Component for Any Reason) | Survival was estimated by Kaplan-Meier method. Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Knee Society Evaluation - Total Score | American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability. | 2 year | 
| American Knee Society Evaluation - Total Score | American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability. | Minimum 5 years, up to 7.6 years | 
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score | WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome. | 2 year | 
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score | WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome. | Minimum 5 years, up to 7.6 years | 
| Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm) |  | Minimum 5 years, up to 7.6 years | 
| Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm) |  | Minimum 5 years, up to 7.6 years | 
| Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm) |  | Minimum 5 years, up to 7.6 years | 
| Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm) |  | Minimum 5 years, up to 7.6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Replacement, Knee