Prospective, Comparative, Randomized Study of GVF Versus Cross-linked Polyethylene in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 938
- 试验地点
- 9
- 主要终点
- Survivorship (Revision of Any Component for Any Reason)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
GVF
Gamma Vacuum Foil polyethylene tibial insert
干预措施: total knee arthroplasty (Device)
P.F.C.
Cross-linked polyethylene tibial insert
干预措施: total knee arthroplasty (Device)
结局指标
主要结局
Survivorship (Revision of Any Component for Any Reason)
时间窗: 5 years
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.
次要结局
- American Knee Society Evaluation - Total Score(Minimum 5 years, up to 7.6 years)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score(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)
- American Knee Society Evaluation - Total Score(2 year)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score(2 year)