Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System). Prospective, Monocentric, Randomized, Open Label Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- proportion of patients with Angle Hip Knee Ankle (HKA) (lower limb axis) restitution at 178 ° +/- 2 ° when the foot is touched with the floor and during the single support phase.
研究概览
简要总结
Unicompartmental knee arthroplasty by unicompartmental prosthesis (PUC) is a treatment for isolated internal femoro-tibial osteoarthritis. This intervention is justified in cases of significant discomfort, failure of medical treatment and the absence of osteoarthritis in femoro tibial external and patellofemoral femoro compartments. It aims to replace the native internal femoral tibial articulation by a joint between two implants, without intervening on the other compartments. The functional results of PUC are superior and faster than those obtained with total knee arthroplasty (TKA). Its indications and its realization are on the other hand very demanding to allow an optimal functional result.
Robotic-assisted surgery provides an excellent level of precision, which could allow better positioning of implants, compared to the use of a mechanical ancillary, according to the first published studies. The functional results and survival of these implants could also be improved.
The internal PUC with mechanical ancillary is carried out for many years in the orthopedic surgery department of Croix Rousse. For 3 years this surgery is sometimes performed with robotic assistance.
The investigators would like to prospectively evaluate the clinical and radiological impact of robotic-assisted surgery when performing a Journey unicompartmental prosthesis (Smith & Nephew).
The assessment of alignment during walking seems to be a paramount parameter in the results of the PUC and has not so far been evaluated in this type of robotic-assisted surgery.
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
- •Male or female adult (age ≥ 18 years)
- •Diagnosis of unicompartmental knee osteoarthritis ( osteoarthritis internal femoral tibial (AFTI))
- •Indication of unicompartmental knee arthroplasty of first intention posed
排除标准
- •History of femoral or tibial osteotomy of valgization or varisation
- •Reconstruction of the associated cruciate ligament
- •Refusal to participate in the study
- •Pregnant women, parturient or nursing mothers
- •Persons deprived of their liberty by a judicial decision or administrative staff, persons under psychiatric care, persons admitted to a health or social institution to other purposes.
- •Major persons subject to a legal protection measure or unable to express their consent
- •Patient not affiliated to a social security scheme
- •Patient participating in another interventional research excluding routine care research (former regulation) and category 2 searches not interfering with criterion analysis main
研究组 & 干预措施
internal PUC implanted with mechanical ancillary
干预措施: internal PUC implanted with mechanical ancillary (Procedure)
Internal PUC implanted with robotic assistance
干预措施: Internal PUC implanted with robotic assistance (Procedure)
结局指标
主要结局
proportion of patients with Angle Hip Knee Ankle (HKA) (lower limb axis) restitution at 178 ° +/- 2 ° when the foot is touched with the floor and during the single support phase.
时间窗: At 6 month postsurgery
This criterion will be measured using a KneeKG system for dynamic analysis of knee movements. This system is non-invasive, non-radiating, non-painful. It is a dynamic tibiofemoral tracing device by infrared camera validated. The KneeKG system will be used according to its instructions for use.
次要结局
- Radiological positioning of implants(At 6 month and 24 month postsurgery)
- Comparison of the means of the International Knee Society (IKS) overall score between the groups.(At 6 month and 24 month postsurgery)
- Comparison of the Forgotten Joint Score(At 6 month and 24 month postsurgery)