Randomized Controlled Trial to Compare Persona OsseoTi Keel Cementless TKA vs Persona Keel Cemented TKA
概览
- 阶段
- 不适用
- 干预措施
- Cementless Persona Knee System
- 疾病 / 适应症
- Knee Pain Chronic
- 发起方
- Zimmer Biomet
- 入组人数
- 300
- 试验地点
- 15
- 主要终点
- Oxford Knee Score (OKS)
- 状态
- 进行中（未招募）
- 最后更新
- 5天前
概览
简要总结
The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.
详细描述
This is a prospective, multi-center, randomized controlled trial to demonstrate safety, performance, and clinical benefits of the Persona Keel CR Knee System and instrumentation. Participants that meet eligibility criteria and sign an institutional review board (IRB) Informed Consent form will be randomized to receive either the Persona OsseoTi Keel Cementless System or the Persona Keel Cemented System. Participants will be blinded to which arm they have been randomized to until after surgery. All study participants will undergo preoperative clinical evaluations prior to their total knee arthroplasty. Investigators will collect clinical data for up to 5 years; follow-up clinic visits will occur at 3 months, 1 year, 2 years, and 5 years after surgery. A maximum of 10 sites will contribute to this study. There will be a maximum of 300 participants enrolled (150 Cementless, 150 Cemented).
研究者
入排标准
入选标准
- •Patient is of legal age and skeletally mature
- •Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document
- •Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
- •Independent of study participation, patient qualifies for either cemented or cementless total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Keel Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling.
排除标准
- •Patient is unwilling to sign the Informed Consent
- •Patient is currently participating in any other surgical intervention or pain management study
- •Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study would be inappropriate (e.g., prisoner; pediatric patients)
- •Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
- •Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study
- •Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
- •Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
- •Study Device-Specific Exclusion Criteria:
- •Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
- •Insufficient bone stock on femoral or tibial surfaces.
研究组 & 干预措施
Cementless Persona Keel Knee System
Persona PPS CoCr Cementless Femur and Persona OsseoTi Keel Cementless Tibia
干预措施: Cementless Persona Knee System
Cemented Persona Keel Knee System
Persona Keel Cemented Tibia
干预措施: Cemented Persona Knee System
结局指标
主要结局
Oxford Knee Score (OKS)
时间窗: 5 years
A 12-item PROM was specifically designed and developed to assess function and pain after TKA. This tool is short, reproducible, valid, and sensitive to clinically important changes. Possible scores range from a minimum 0 to maximum 48 points, with higher scores indicating less pain and fewer functional limitations. The primary endpoint is based on the change in OKS scores from baseline to 2-year postoperative follow-up as well as from baseline to 5-year postoperative follow-up.
次要结局
- Frequency and types of Adverse Events(5 years)
- EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire(5 years)
- Patient Expectations Pre- and Post-op(5 years)
- Survival Rate of Implant(5 years)
- Rate of Radiolucencies(5 years)
- Numeric Rating Scale (Pain)(5 years)