Prospective, Multicenter Study Evaluating the Midterm Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Knee Implant
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aesculap AG
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Functional patient-reported outcome
研究概览
简要总结
The study is designed as a prospective, observational, mid-term, multi-center follow-up study. It is planned to include 150 patients from 4 different study centres in Germany.
详细描述
The product under investigation is used in routine clinical practice and according to the authorized Instructions for Use (IfU). The data that is obtained in routine clinical use will be documented in an electronical Case Report Form (eCRF). The study's main purpose is the collection of clinical data on the safety and performance of the redesigned univation® XF Pro implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Indication for a primary medial unicompartmental knee endoprosthesis
- •Acc. to Instructions for Use:
- •Both cruciate ligaments intact
- •Lateral ligaments intact
- •Leg axis amenable to passive correction
- •Varus deformity under 15°
- •Bending capability of at least 90°
- •Extension deficit no greater than 5-10°
- •Written informed consent of patient
- •Kellgran & Lawrence Score > II (only straight or varus
- •Patients with moderate radiological symptoms
- •Patients without clinical symptoms
排除标准
- •Pregnancy
- •Patient age <18 and > 75 years
- •High risk patients ASA > III
研究组 & 干预措施
univation® XF Pro
Primary medial unicompartmental knee arthroplasty treated with implantation of unicompartmental knee prosthesis univation® XF Pro
干预措施: univation® XF Pro (Device)
结局指标
主要结局
Functional patient-reported outcome
时间窗: 5 years post-op
The Oxford Knee Score (OKS) is a reliable 12-item, patient-reported questionnaire originally developed and validated specifically to assess function and pain in patients undergoing total knee replacement. It is short, reproducible, valid and sensitive to clinically important changes over time. Each of the 12 questions on the OKS is scored in the same way with the score decreasing as the reported symptoms increase (i.e. become worse). All questions are laid out with response categories denoting least (or no) symptoms to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0), as detailed for question 1 below. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome.
次要结局
- Implant survival [Kaplan-Meier](until 5 years postoperatively)
- Quality of Life [EQ-5D-5L] compared to baseline(Preoperatively (baseline) and 3 months, 1 year, 2 years, 5 years postoperatively)
- Progress of Clinical Outcome [Forgotten Joint Score-12] over follow-up period(3 months, 1 year, 2 years, 5 years postoperatively)
- Radiological assessment: axis alignment (long leg x-ray) over time(at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively)
- Radiological assessment: comparison of tibial slope over time(at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively)
- Radiological assessment: Patella x-ray(at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively)
- Number of Adverse events / serious adverse events over time(During the course of the study up to 5 years postoperatively)
- Number of Participants with radiological complications over time(During the course of the study up to 5 years postoperatively)