Customized Knee Arthroplasty With or Without Posterior Cruciate Ligament Retention: A CR-PS Approach
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Forgotten Joint Score (FJS-12) at 24 Months Postoperatively
研究概览
简要总结
Background and Rationale:
Conventional mechanical implantation of total knee arthroplasty (TKA) aims to establish a lower-limb mechanical axis of 180°. Computer-assisted personalized implantation aims to restore a pre-arthritic alignment while respecting the soft-tissue envelope of the knee. Depending on design, TKA implants may either retain or sacrifice the posterior cruciate ligament (PCL). In mechanically implanted TKAs, functional outcomes of cruciate-retaining (CR) and posterior-stabilized (PS) designs are reported as comparable in the literature. However, these two designs have not been compared within a computer-assisted personalized implantation workflow. Objective and Hypothesis:
The objective of this randomized comparative study is to compare functional outcomes (patient-reported outcome measures - PROMs) at 24 months postoperatively following CR versus PS knee arthroplasty implanted with a personalized technique. The hypothesis is that there is no significant difference in functional outcomes between CR and PS prostheses implanted using a personalized technique. Study Design:
Single-center, open-label, randomized, two-arm parallel-group trial comparing a group of patients receiving a cruciate-retaining (CR) total knee prosthesis to a group receiving a posterior-stabilized (PS) total knee prosthesis.
详细描述
Prior to hospitalization, the study will be proposed to patients by telephone 21 days before surgery. Following explanation of the study, answering patient questions, and obtaining oral agreement, the information leaflet will be sent by mail for review until hospitalization, when written informed consent is obtained. After signing consent, participants are randomized to either the CR or PS group. Preoperative Phase:Active joint range of motion measured using a goniometer. Completion of patient-reported questionnaires: Forgotten Joint Score (FJS-12), Knee Injury and Osteoarthritis Outcome Score (KOOS), Subjective Knee Value (SKV), and Net Promoter Score (NPS). Standard preoperative imaging (weight-bearing radiographs, skyline view, goniometry) to assess anatomical alignment and plan implant positioning. Intraoperative Phase:Navigation data and surgical characteristics will be documented on the Case Report Form (CRF), including:Surgical approach and necessity for PCL or collateral ligament release. Rates of conversion from CR to PS prosthesis. Initial and final HKA angle and flexion contracture. Femoral and tibial resection parameters (thickness, slopes, cut obliquities, rotation). Thickness of the implanted polyethylene insert. Postoperative Follow-up Phase (3, 12, and 24 months):Distribution and completion of follow-up PROMs (FJS-12, KOOS, SKV, NPS) during routine follow-up visits. Evaluation of knee joint range of motion (ROM) and clinical stability. Assessment and recording of audible knee clicking, patellar complications, and surgery-related adverse events (including revision, manipulation under anesthesia, or prosthetic loosening).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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 information provided and signed written informed consent obtained in duplicate
- •Male and female participants aged 18 years or older
- •Primary total knee arthroplasty for knee osteoarthritis performed in the orthopaedic surgery department
排除标准
- •History of posterior cruciate ligament (PCL) rupture or prior ligamentoplasty
- •History of ipsilateral femur or tibia fracture
- •Coronal plane axial deviation greater than 15 degrees (HKA < 165° or > 195°)
- •Flexion contracture (flexum) greater than 15 degrees
- •Tibial slope greater than 10 degrees
- •Patient deprived of liberty by judicial or administrative decision
- •Patient not affiliated with or beneficiary of a national social security scheme
- •Patient unable to understand French
- •Patient whose place of residence is incompatible with close in-person follow-up consultations
- •Woman of childbearing potential not using effective contraception
- •Pregnant or breastfeeding woman
- •Adult patient unable or unfit to give informed consent
研究组 & 干预措施
A group of patients implanted with a knee prosthesis with preservation of the posterior cruciate (PC
干预措施: Implantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practice (Procedure)
A group of patients implanted with a knee prosthesis without preservation of the posterior cruciate
干预措施: Implantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practice (Procedure)
结局指标
主要结局
Forgotten Joint Score (FJS-12) at 24 Months Postoperatively
时间窗: 24 months postoperatively
Patient-reported joint awareness and functional outcome assessed using the Forgotten Joint Score (FJS-12) questionnaire. The total score ranges from 0 to 100, where 0 represents the worst outcome (high joint awareness) and 100 represents the best possible outcome (complete forgetfulness of the artificial joint). Higher scores indicate better functional outcome and joint naturalness.
次要结局
- Change from Baseline in Knee Range of Motion (ROM)(Baseline (preoperative), 3 months, 12 months, and 24 months postoperatively)
- Incidence of Audible Knee Clicking(3 months, 12 months, and 24 months postoperatively.)
- Rate of Patellar Complications(Through 24 months postoperatively.)
- Intraoperative Surgical Navigation and Alignment Parameters(Intraoperative (Day 0))
- Incidence of Surgery-Related Major Adverse Events(Through 24 months postoperatively)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Baseline (preoperative), 3 months, 12 months, and 24 months postoperatively)
- Forgotten Joint Score (FJS-12) at 3 and 12 Months Postoperatively(3 months and 12 months postoperatively.)
- Subjective Knee Value (SKV) Score(3 months, 12 months, and 24 months postoperatively.)
- Net Promoter Score (NPS) for Patient Satisfaction(3 months, 12 months, and 24 months postoperatively.)