NCT07843966尚未招募不适用
Post-Market Clinical Follow-Up Study to Provide Long-term Safety, Performance and Clinical Benefits Data of the Persona® Revision Knee System (Implants and Instrumentation)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Zimmer, GmbH
- 入组人数
- 238
- 试验地点
- 2
- 主要终点
- Change in Oxford Knee Score (OKS) from Baseline to 2 Years
研究概览
简要总结
The purpose of this post-market clinical follow-up study is to confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and Instrumentation in revision Total Knee Arthroplasty.
详细描述
Study Design:
This is a multicenter, Prospective, Non-controlled, Non-randomized, Consecutive series of patients, Dual cohort study.
Objectives:
- Confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and its Instrumentation when used in revision TKA.
- Confirm that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording Patient-Reported clinical Outcome Measures (PROMs) and radiographic outcomes (if standard of care).
Condition Being Treated/Target population:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient qualifies for a revision knee arthroplasty with the Persona Revision Knee System. Full or partial/hybrid revision cases that fall within the revision knee indication are allowed to be included in the study (not first joint replacement).
- •Patient experiences severe knee pain and disability due to:
- •The salvage of previously failed knee surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
- •One-stage revision performed for infection OR
- •Second stage (reimplantation) of a planned two-stage revision.
- •Patient is ≥ 18 years.
- •Patient is skeletally mature.
- •Patient is willing and able to complete scheduled follow-up evaluations as described in the Protocol and Informed Consent Form.
- •Patient has participated in the Informed Consent process and is willing and able to sign the Informed Consent Form.
排除标准
- •Patient received the study device for any condition not listed in the indications or in combination with a non-compatible device.
- •First Knee Replacement patients.
- •Patient with only inlay/bearing exchange/revision.
- •Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition.
- •Patient has any of the following contraindications:
- •Any active or suspected latent infection in or about the knee joint or distant foci of infection which may cause hematogenous spread to the implant site: In any case, the infection needs to be treated prior to the revision surgery.
- •Insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and/or fixation to the prosthesis.
- •Skeletal immaturity.
- •Neuropathic arthropathy.
- •Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.
- •A stable, painless arthrodesis in a satisfactory functional position
- •Severe instability secondary to the absence of collateral ligament integrity.
- •Diagnosis of rheumatoid arthritis in conjunction with any of the following at the preoperative appointment: An ulcer of the skin, history of recurrent breakdown of the skin, use of steroids.
- •Patients in whom the Persona Revision Knee System is used as a temporary, interim, spacer-type, or destination-spacer construct are not eligible, including use in a 1.5-stage revision strategy or as the first-stage construct in a planned 2-stage revision. Enrollment is restricted to subjects in whom the Persona Revision Knee System is implanted as the surgeon-intended definitive revision knee arthroplasty following infection eradication.
- •Patient underwent contralateral total knee arthroplasty within 3 months of the planned index procedure or has a contralateral total knee arthroplasty planned within 3 months of the index procedure.
- •Patient is known to be pregnant or planning to become pregnant during the time they will be participating in the study.
- •Patient is a member of a vulnerable population group, such as
- •A prisoner.
- •A known alcohol or drug abuser.
- •Mentally incompetent or unable to understand what participation in this study entails.
- •Patient with suspected or confirmed metal sensitivity or allergy to the metals of the device.
研究组 & 干预措施
Cohort 1: Persona Revision Knee + CCK articular surface
From the total sample size (238 cases), 119 cases will be implanted with the Persona Revision Knee and the CCK articular surface.
Cohort 2: Persona Revision Knee + CPS or PS articular surface
From the total sample size (238 cases), 119 cases will be implanted with the Persona Revision Knee and CPS or PS articular surface.
结局指标
主要结局
Change in Oxford Knee Score (OKS) from Baseline to 2 Years
时间窗: From baseline (pre-operative assessment) to 2 years after surgery
Average change in Oxford Knee Score (OKS) from baseline to 2 years follow-up. The average change will be evaluated against the Minimal Clinically Important Difference (MCID) of 4.0 points.
次要结局
- All-Cause Implant Survival(From surgery up to 10 years post-surgery)
- Adverse events / Safety(From surgery up to 10 years of follow-up)
- Oxford Knee Score - follow-up beyond the primary endpoint(Baseline, 3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery)
- EQ-5D-5L Health Related Quality of Life(Baseline, 3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery)
- Patient Satisfaction with the Study Knee and Treatment(3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery)
- Percentage (%) of Participants with significant radiographic findings(From baseline up to 10 years after surgery)
研究者
研究点 (2)
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