Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis Indicated for the Treatment of Primary and Secondary First Line Gonarthrosis and Revision Arthroplasty - 2 Years Follow-up - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- FH ORTHO
- 入组人数
- 92
- 试验地点
- 14
- 主要终点
- Functional performance
研究概览
简要总结
The life expectancy worldwide is increasing and leading to an increase of knee arthroplasty. Also, as millions of people around the world are currently living with a Total Knee Arthroplasty (TKA), the need for revision surgery represents a large public health burden. In this context, FH ORTHO company develops FHK®-CK (prosthesis + ancillary equipment) which is a knee prosthesis for complex first intention and revision knee arthroplasty. This new medical device complements the FHK® standard first-line range (CE marked).
The FHK®-CK ancillary equipment were designed by expert knee surgeons and is simple, reliable and reproducible. It allows for maximum versatility while remaining compact.
By completing the FHK® range of first intention prostheses, the FHK®-CK allows the surgeon to be on the same level as the competitors by having a first intention and semi-constrained prosthesis. This prosthetic arsenal allows the surgeon to opt for the best solution for his patient so that he can regain mobility and a satisfactory quality of life. Also, in case of failure of the FHK® first-line prosthesis, it will provide the surgeon and the patient with a simple alternative to prosthesis replacement. As it has been developed in line with the first intention, inter-compatibility between the two systems is possible, which simplifies the surgical procedure and reduces the risks for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 requiring knee arthroplasty for primary or secondary gonarthrosis:
- •* For primary intention arthroplasty: Patient with either
- •major axial deviation,
- •major peripheral failure or
- •bone defect;
- •* For prosthesis revision surgery: Patient who have had a failed 1st implantation, with or without bone defects.
- •Patient able to understand and answer the questionnaires provided by the protocol;
- •Subject affiliated to a health insurance system or is a beneficiary;
- •Signed informed consent form (ICF) for participation to the research.
排除标准
- •Patient with an ongoing acute infection, outside knee to be operated;
- •Patient with a mental or neuromuscular disorder that would create an unacceptable risk of prosthetic instability, prosthetic fixation failure or post-operative complications;
- •Patient with a known allergy to any of the components of the FHK®-CK implants (Nickel, Cobalt, Chromium);
- •Patient with a dependency (drug, alcohol,...) that could affect his/ her ability to comply with the protocol, at the investigator's discretion;
- •Patient requiring knee reconstruction;
- •Patient with any medically significant findings or significant history that may impact the safety, interpretation of results, and/ or participation of the subject in the clinical trial, as determined by the investigator;
- •Patient with an existing knee or hip prosthesis (outside knee to be operated) that may impact the evaluation of the FHK®-CK prosthesis;
- •Patient concurrently participating in another clinical trial or who has recently participated in another clinical trial for which the exclusion period has not been completed.
- •Vulnerable subjects :
- •Pregnant, parturient, or breastfeeding women,
- •Subject deprived of liberty, hospitalized without consent or admitted to a health or social establishment for purposes other than that of research,
- •Adult under protective supervision (tutorship, curatorship),
- •Subject not able to understand the subject information leaflet (e.g. for linguistic or psychiatric reasons) and/or to give informed consent
研究组 & 干预措施
Knee replacement
Implantation of FHK-CK prosthesis either for a complex primary arthroplasty or for revision intend
干预措施: Total Knee arthroplasty (Device)
结局指标
主要结局
Functional performance
时间窗: Baseline (preoperatively), at 6 weeks, 6 months, 12 months and 24 months after surgery.
Evolution of the functional performance of FHK®-CK prosthesis using the KSS scoring system, which is composed of 2 sections : Knee score (KSKS) and function score (KSFS). Each section is scored on a scale of 0 to 100 ; the higher the score, the better the overall functionality of the knee. The functional performance of the FHK®-CK prosthesis will be demonstrated at 2 years if an improvement of the KSKS and KSFS scores at least equal to the Minimal Clinically Important Difference (MCID) values is observed.
次要结局
- Adverse and serious adverse events evaluation(Through study completion, an average of 2 years)
- Revision rate evaluation(At 6 weeks, 6 months, 12 months and 24 months after surgery.)
- Evaluation of patient's tolerance of the FHK-CK prosthesis(At 6 weeks, 6 months, 12 months and 24 months after surgery.)
- Device deficiencies evaluation(Through study completion, an average of 2 years)
- Patient's satisfaction about FHK®-CK prosthesis(At 6 months, 12 months and 24 months after surgery)
- Surgeon's satisfaction about FHK®-CK equipment(During surgery)
- Quality of life assessment(Baseline (preoperatively), at 6 months, 12 months and 24 months after surgery.)