Prospective, open-label, multicentre, non-randomized, non-interventional, exploratory, comparative, uncontrolled Post Market Clinical Follow-Up Study of the Modular Revision Support (MRS)-Titan® Comfort - 2015-01-MRS-C

PETER BREHM GmbH0 个研究点目标入组 120 人开始时间: 2018年6月29日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Congenital or acquired hip joint defects
•Arthrosis (degenerative, rheumatic)
•Joint replacement (revision) already carried out and worn or in case of failed surgery
•Defect of the geometric rotation center
•Defects or malfunctions of the hip joint
•Post-traumatic arthritis
•Severe deformities (e.g. osteomyelitis)

•Obesity or overweight of the patient
•Acute or chronic infections near the implantation
•All cases in which a stable anchoring of the implant cannot be achieved
•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 hip implant
•Lack of patient cooperation
•Abuse of medication, drug abuse, alcoholism or mental disease
•Pregnancy
•Serious damage to the bone structures, which might endanger stable implantation of the implant components (at least 1 mandrel screw)
•Systemic diseases and metabolic disorders
•Overload of the hip implant to be expected
•In justified cases in which, despite one of the contra-indications described above, an implantation is considered to be medically necessary, the following must be observed:
•The load capability of the material used in the device and for the fixation is limited.
•Contra-indications must be reduced as far as possible.
•Patients younger than 18 years
•Participate in another clinical trial and receive / use experimental or unauthorized medicines or medical devices.
•Existing disease of the other (unscheduled) hip with planned (surgical) intervention within the next 12 months.
•Patients who can be put under pressure to volunteer.

发起方