Comparing Hybrid and Cemented TKA Using the NexGen LPS Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Postoperative functional outcome as measured by the Knee and Osteoarthritis Outcome Score (KOOS) and compare if hybrid NexGen LPS TKA leads to equally successful results as the cemented NexGen LPS TKA.
研究概览
简要总结
Early total knee arthroplasty (TKA) implant systems most frequently used an all-polyethylene cemented tibial component1. Based on finite-element analysis studies reporting superior force distribution compared with conventional all-polyethylene components, metal-backed tibial baseplates have dominated the TKA implant market since the middle of the 1980's2. These modular implants provided excellent long-term implant survivorship3.
As TKA became increasingly successful, younger patients increasingly became eligible. Increasing life expectancy has raised the concern that cemented TKAs may not withstand prolonged use, particularly in younger patients4. Patients younger than 65 years are projected to account for more than 50% of patients undergoing TKA by 2016 and to more than 50% of patients undergoing revision surgery by 2011. The number of total knee revisions in the United States is expected to increase from 38,300 in 2005 to 268,200 in 20305.
Many authors have reported excellent and equivalent results of cemented and cementless TKA6-8. Despite these encouraging reports, the major concern with cementless TKA has been the tibial component, and, therefore, the preference for many surgeons still remains to cement the tibial component9,10. The femoral component may be the most suitable for cementless fixation11-13. However, the best femoral method of fixation is still being discussed. Currently, the decision to cement or not to cement the femoral component is based on the surgeon's preference14.
The current study was designed to compare the hybrid NexGen LPS (Zimmer Inc, Warsaw, IN) and the cemented NexGen LPS. The purpose of this study is to establish whether the hybrid NexGen LPS leads to equally successful results as the cemented TKA gold standard
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients may be included in the study only if they meet the following criteria:
- •Patient is able to provide informed consent.
- •Patient is between 18 and 75 years of age.
- •Patients are willing and able to attend all follow-up visits and complete all study requirements. They must agree to comply with all study related procedure, including understanding and adhering to the rehabilitation protocol.
- •Patient has primary or secondary knee osteoarthritis.
- •Patient has sufficient bone quality for total knee arthroplasty.
- •Patient is in stable health.
- •Female patients are not pregnant at times of surgery and do not plan on becoming pregnant during the study.
- •Note: patient can only enter the project with one knee
排除标准
- •Neuromuscular or vascular disease in the affected leg.
- •Patients with osteoporosis based on former diagnosis or preoperative DEXA-scan.
- •Fracture sequelae or previous HTO or previous extensive knee surgery.
- •Patients with need of a stem-elongation.
- •Patients who cannot refrain from taking NSAID post-operatively.
- •Patients with metabolic bone disease.
- •Patients with renal disease.
- •Patients with rheumatoid arthritis.
- •Postmenopausal women in estrogenic hormone substitution
- •Patients with a continuous need of systemic cortisone treatment.
- •Non-Spanish citizenship.
- •Patients who do not comprehend the Spanish language (read and speak).
- •Senile dementia.
- •Alcohol abuse - defined as men drinking more than 21 units a week and women drinking more than 14 units a week.
- •Drug abuse.
- •Major psychiatric disease.
- •Metastatic cancer disease and treatment with radiation therapy or chemotherapy
研究组 & 干预措施
Hybrid NEXGEN LPS
Noncemented femoral component with cemented tibial component with the NexGen LPS Total Knee Arthroplasty
干预措施: Total knee arthroplasty (Procedure)
Hybrid NEXGEN LPS
Noncemented femoral component with cemented tibial component with the NexGen LPS Total Knee Arthroplasty
干预措施: NEXGEN LPS total knee arthroplasty (Device)
Cemented NEXGEN LPS
Cemented femoral component with cemented tibial component with the NexGen LPS Total Knee Arthroplasty
干预措施: Total knee arthroplasty (Procedure)
Cemented NEXGEN LPS
Cemented femoral component with cemented tibial component with the NexGen LPS Total Knee Arthroplasty
干预措施: NEXGEN LPS total knee arthroplasty (Device)
结局指标
主要结局
Postoperative functional outcome as measured by the Knee and Osteoarthritis Outcome Score (KOOS) and compare if hybrid NexGen LPS TKA leads to equally successful results as the cemented NexGen LPS TKA.
时间窗: 1 year
The current study will be designed as equivalence trial. The amount of allowable difference is the margin that defines the "zone of indifference" within which the interventions are considered equivalent. The KOOS has a Minimally Clinically Important Difference (MCID) of 8 - 10 points, and the standard deviation in a cohort of TKA patients is ca. 15 points. The null hypothesis (of non-equivalence) of the study is that functional outcome at 10 years of follow-up in the hybrid group is not equal to the functional outcome at 10 years of follow-up in the cemented group, or: H: ϑ ≤ ϑ0 - δ1 or ϑ ≥ ϑ0 + δ1, versus the equivalence assumption that functional outcome at 10 years of follow-up in the hybrid group is equivalent to the functional outcome at 10 years of follow-up in the cemented group: K: ϑ0 - δ1 \< ϑ \< ϑ0 + δ1.
次要结局
- Postoperative functional outcome as measured by Knee Society Score.(up until 10 years of follow up)
- Incidence and extend of radiolucent lines (RLL) as measured by standard radiography.(Up to 10 years.)
研究者
Jesus Moreta Suarez
MD, FEBOT
Hospital Galdakao-Usansolo