Constraint choice in revision knee arthroplasty: study protocol of a randomised controlled trial assessing the effect of level of constraint on postoperative outcome - Not applicable

KH MOL GmbH0 个研究点目标入组 170 人开始时间: 2016年5月30日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Indications are:
•- Rheumatoid arthritis
•- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result
•- Failed osteotomies, unicompartmental replacement, or total knee replacement
•In addition, the patient has to fulfil the following criteria to be eligible for the study:
•- The patient is scheduled for elective primary or revision knee arthroplasty
•- The patient is 18 years or older. There are no upper age limits for the study, as long as the patient is healthy enough to undergo surgery
•- The patient is willing to provide informed consent

•- The patient participates in another concurrent study
•- Major psychiatric disease
•- Patients who do not comprehend the German language (read and speak)
•- Pregnancy, lactation, or childbearing potential without using adequate contraception
•- Acute or chronic infections, local or systemic (or corresponding previous incidents)
•- Severe muscle, nerve, or vascular diseases that endanger the extremity in question
•- Lacking bone substance or possessing inadequate bone quality that endangers a stable seating of the prosthesis
•- Extreme insufficiency of the knee extensor mechanism
•- Adipositas permagna
•- Local tumours
•- Known hypersensitivity to the material

发起方

KH MOL GmbH