NCT03097471Unknown不适用
Prospektive, Klinische Studie Zur Marktbeobachtung (Post Market Follow-Up Study) Der Knieendoprothese BPK-S Integration Aus Keramikwerkstoff BIOLOX (R) Delta (Prospective Clinical Post Market Follow-up Study of the Total Knee Endoprosthesis BPK-S (Brehm Precision Knee System)Made of Ceramic Material BIOLOX (R) Delta
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Improvement of Knee Society Score
研究概览
简要总结
Post-market prospective clinical study with a medical device. Data from patients that routinely receive a primary BPK-S-integration knee implant made of ceramic will be documented with a follow-up time of 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital or acquired knee joint defects/deformation which necessitate the implantation of a knee joint replacement
- •Defects or malfunctions of the knee joint
- •Degenerative, rheumatic, post-traumatic arthritis/arthrosis
- •Symptomatic knee instability
- •Reconstruction of flexibility
- •Patients with material hypersensitivity
排除标准
- •Obesity or overweight of the patient
- •Acute or chronic infections near the implantation
- •Diseases that impair bone growth such as cancer, renal dialysis, osteopenia, etc.
- •Sensitivity to foreign matter in the implant materials
- •Bone tumors in the area of the implant anchoring
- •Illnesses which can be treated without using a knee implant
- •Lack of patient cooperation
- •Abuse of medication, drug abuse, alcoholism or mental disease
- •Pregnancy
- •Serious osteoporosis
- •Serious damage to the bone and soft tissue structures which impedes stable anchoring and joint function
- •Systemic diseases and metabolic disorders
- •Overload of the knee implant to be expected
结局指标
主要结局
Improvement of Knee Society Score
时间窗: 12 months
次要结局
- Improvement of EQ-5D (Euroquol 5 dimension) score(3 month, 12 months, 24 months)
- Documentation of Complications(3 month, 12 months, 24 months)
- Improvement of Knee Society Score over the course of the study(3 months, 24 months)
- Improvement of Oxford Score(3 month, 12 months, 24 months)
研究者
Klemens Trieb
Univ. Prof. Dr. Klemens Trieb
Klinikum Wels-Grieskirchen
相似试验
已完成
不适用
Prospective Observational Study for the Evaluation of VEOFIX Varisation StaplesHallux ValgusNCT05523219Societe dEtude, de Recherche et de Fabrication81
终止
不适用
Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the DeviceHip DiseaseHip FracturesNCT04193163FH ORTHO10
进行中（未招募）
不适用
Study Conducted on Patients Operated With a FHK ASYMETRIQUE to Confirm Security and Performance of the DeviceKnee DiseaseNCT04221581FH ORTHO43
已完成
不适用
LifeVest Safety and Efficacy in Real Life Settings in FranceLeft Ventricular DysfunctionCardiac EventCardiac ArrythmiasSudden Cardiac DeathNCT03319160Zoll Medical Corporation1,164
招募中
不适用
An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac ArrhythmiasNCT04750798Biosense Webster, Inc.8,000