A Prospective, Single-blind, Multi-Centre, Randomised Controlled Study to Evaluate the Clinical and Patient Reported Outcomes Following Unicompartmental Knee Arthroplasty With a Robotic Assisted Technique
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 280
- 试验地点
- 10
- 主要终点
- Implant Survival at 10 years
研究概览
简要总结
The overall aim of this trial is to compare functional and patient-reported outcomes and to assess the safety and effectiveness and long-term performance of the Smith+Nephew Robotic Systems for Unicompartmental Knee Replacements to non-robotic, conventionally implanted Unicompartmental Knee Replacements.
详细描述
There are two phases for this study:
- Phase 1: The primary objective of this study is to compare Forgotten Joint Score (FJS) 12-month patient reported outcome scores, in patients undergoing robotic assisted Unicompartmental Knee Replacements as compared to those undergoing conventionally implanted Unicompartmental Knee Replacements
- Phase 2: The primary objective of Phase 2 of this study is evaluate the revisions rates of the JII UK unicompartmental knee at 10 years
Research participants / locations:
280 research participants will be recruited from up to 15 sites in the UK, US and Europe. There will be 140 participants undergoing robotic assisted Unicompartmental Knee Replacements and 140 participants undergoing non-robotic, conventionally implanted Unicompartmental Knee Replacements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single-blinded to study participant. The study participants will not be aware of the treatment received. For those not being put under general anesthetic during the procedure, a screen will be put up between the subjects face and the ongoing procedure and associated platforms/instrumentation so that they are unable to see any of the procedure and are unable to guess whether they are having robotics assisted surgery or conventional surgery. Extra incisions (maximum of 4 based on approach that the operating surgeon uses) are required to conduct robotic assisted surgery, those subjects receiving conventional surgery will receive sham incisions.
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
- •The subject or, legal guardian (in the case of difficulty reading and/or writing,) must provide written informed consent, including consent for any incidental findings to be reported to their General Practitioner (reference section 7.5).
- •Subjects eighteen (18) years and older and considered to be skeletally mature at the time of surgery.
- •Willing and able to make all required study visits (for both phases of the study, up to 10 years postoperatively).
- •Able to follow instructions and deemed capable of completing all the study questionnaires.
- •The subject has primary arthritis of the knee joint involving one (UKA) compartment (medial or lateral), and is suitable for JOURNEY II UK in the opinion of the surgeon.
- •The subject can, and is willing to have radiographic images taken to include non-standard of care imaging (for long leg radiographs at follow up).
排除标准
- •Contraindications or hypersensitivity to the use of the JII UK implant components (e.g., oxinium femoral, Tibial Baseplate, XPLE insert).
- •The subject is contraindicated for the use of robotic-assisted knee arthroplasty.
- •Participation in the treatment period of another clinical trial within thirty (30) days of the preoperative visit, or during the study.
- •Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
- •Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.
- •Subjects who have participated previously in this trial through UKR on other knee.
- •The subject is listed for a simultaneous bilateral knee arthroplasty
- •Subjects experiencing severe pain in both knees and consequently anticipating bilateral surgery within 12 months.
- •The subject requires a complex implant or any other implant, other than a standard UKR (e.g. stems, augments or custom-made devices)
- •Subject has an active infection or sepsis or has had previous intra-articular infections
- •Subjects with a history of poor compliance with medical treatment
- •The subject, in the opinion of the investigator, has a neuromuscular disorder (e.g. Charcot joint) that prohibits control of the index joint
- •Cases where bone stock is poor and would therefore make the procedure unjustifiable
- •Subjects with a BMI of 40 or higher
- •Those with incomplete/sufficient soft tissue around the joint.
- •Subjects with Conditions that tend to place increased loads on implants such as age, weight, and activity level, which are incompatible with a satisfactory long-term result.
- •Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
结局指标
主要结局
Implant Survival at 10 years
时间窗: 10 years post operative
Number of participants with implant survival at 10 years with survival defined as lack of unicompartmental knee arthroplasty (UKA) revision.
Forgotten Joint Score 12 (FJS-12) at 12 Months Post Operative
时间窗: 12 months post operative
The Forgotten Joint Score 12 (FJS-12) is a self-administered score where subjects are asked to rate their awareness of their knee arthroplasty in 12 questions with a five-point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores are summed and linearly transformed in a 0 to 100 scale with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living.
次要结局
- EuroQol Five-Dimensional Five-Level (EQ-5D-5L) - Descriptive System(Pre-operative, 6 weeks, 6 months, 12 months, 2 years, 5 years, 10 years post operative)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Pre-operative, 12 months, 2 years, 5 years, 10 years post operative)
- Forgotten Joint Score 12 (FJS-12)(Baseline, 6 weeks, 6 months, 2 years, 5 years, 10 years post operative)
- EuroQol Five-Dimensional Five-Level (EQ-5D-5L) - Visual Analogue Scale (VAS)(Pre-operative, 6 weeks, 6 months, 12 months, 2 years, 5 years, 10 years post operative)
- Oxford Knee Score (OKS)(Pre-operative, 6 weeks, 6 months, 1 year, 2 years, 5 years, 10 years post operative)
- Oxford Arthroplasty Early Recovery Score (OARS)(Day 1, day 2, day 3, day 7, day 14, 6 weeks post operative)
- Oxford Arthroplasty Early Change Score (OACS)(Day 1, day 2, day 3, day 7, day 14, 6 weeks post operative)
- Implant Survival at 2 Years and 5 Years(2 years and 5 years post operative)
- Visual Analogue Scale (VAS) - Pain Score(Pre-operative, 6 weeks, 6 months, 12 months, 2 years, 5 years, 10 years post operative)