Clinical Evaluation of the Total Knee Prosthesis Persona Medial Congruent® With Preservation or Sacrifice of the Posterior Cruciate Ligament: a Multicentric Perspective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Evaluate the safety based on implant survivorship at 5 years follow up
研究概览
简要总结
Prospective, multicenter study on the Total Knee Prosthesis available on the market "Persona Medial Congruent® knee".
Primary endpoint
-Evaluation of the survival of the implant after 5 years of follow-up
Secondary endpoints
- Evaluation of the survival of the implant at 10 years of follow up.
- Evaluation of clinical and radiographic outcomes in Italian patients undergoing total knee replacement with the Persona Medial Congruent® implant with sacrifice or retention of the posterior cruciate ligament (PCL)
详细描述
Prospective, multicenter study on the Total Knee Prosthesis available on the market "Persona Medial Congruent® knee" Up to 10 Italian centers will provide a maximum of 200 patients undergoing total knee replacement with Persona prosthesis and Medial Congruent® insert.
20 cases per center will be performed, 10 with posterior cruciate ligament sacrifice, 10 with posterior cruciate ligament preservation.
Patients will be recruited and enrolled in the study according to the inclusion and exclusion criteria specified below. In order to minimize the selection bias, patients will be enrolled consecutively; the first 10 patients will constitute a treatment group and the remaining 10 the complementary group.
Each patient will sign an informed consent for participation in the prospective study. The patients will be recruited at the Orthopedic and Traumatological Clinic 2nd of the Rizzoli Orthopedic Institute on an outpatient or hospitalization basis.
After the surgical treatment, the patient will continue his hospitalization at the Orthopedic and Traumatological Clinic 2nd of the Rizzoli Orthopedic Institute and, if deemed appropriate by the medical team, he will be discharged by planning the subsequent post-operative checks and diagnostic evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The Co-Investigator who assesses the outcomes will be blind to the treatment group's allocation
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient qualifies for a primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
- •Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis
- •Collagen disorders and/or avascular necrosis of the femoral condyle
- •Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
- •Moderate valgus, varus, or flexion deformities
- •The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee
- •Patient is willing and able to complete scheduled study procedures and follow-up evaluations
- •Independent of study participation, patient is a candidate for commercially available Persona MC knee implants. Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
- •Patient has participated in the Informed Consent process and has signed the Ethics Committee approved 'Informed Consent'.
排除标准
- •Patient is currently participating in any other surgical intervention studies or pain management studies
- •Patient is unwilling or unable to give consent or to comply with the follow-up program.
- •Patient meets exclusion criteria of the Instruction for Use Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
- •Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
- •Insufficient bone stock on femoral or tibial surfaces
- •Skeletal immaturity
- •Neuropathic arthropathy
- •Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
- •Stable, painless arthrodesis in a satisfactory functional position
- •Severe instability secondary to the absence of collateral ligament integrity
- •Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
- •Patient has a known or suspected sensitivity or allergy to one or more of the implant materials
结局指标
主要结局
Evaluate the safety based on implant survivorship at 5 years follow up
时间窗: 72 months
Implant survival will be evaluated by radiographic parameters on standard and long leg standing radiographs that indicate prosthesis mobilization (radiolucency lines, fracture, osteolysis)
次要结局
- Adverse Event Report(132 months)
- Return to work(132 months)
- Euro Quality of Life-5 Dimensions-5 Levels Health Questionnaire(132 months)
- Evaluation of medication taken by the patient(132 months)
- Evaluation of muscle strength(132 months)
- Patient Satisfaction Questionnaire(132 months)
- Oxford Knee Score(132 months)
- American Knee Society Score(132 months)
- Evaluation of pain(132 months)
- Evaluate the safety based on implant survivorship at 10 years follow up(132 months)
- Forgotten Joint Score(132 months)
- Explanted Device Form(132 months)