se of a reinforced injectable calcium phosphate bone cement in the treatment of Tibial Plateau fractures - Norian Drillable

Synthes GmbH0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•1.Subjects with closed tibial plateau fractures classified as OTA B2, B3 or C3 resulting in a bone void.
•2.At least 18 years of age.
•3.Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.

•1.Critically ill
•2.Mentally ill or mentally disordered
•3.Wards of the state
•4.Prisoners
•5.Refugees
•6.In an employer - employee, teacher - student relationship or any other dependant with the researchers or their associates
•7.Active or suspected infection - systemic or local
•8.Gustillo classification of 2 or 3
•9.Bilateral tibial plateau fractures when both fracture patterns extend into the joint
•10.Have an existing calcium metabolism disorder (e.g. hypercalcemia)
•11.Chronic renal disease/renal failure
•12.Insulin dependent diabetes
•13.Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
•14.Rheumatoid arthritis or other autoimmune disease.
•15.Systemic disease including AIDS, HIV, hepatitis.
•16.Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
•17.Subjects involved in other studies within the last month, prior to screening.
•18.Pregnant or interested in becoming pregnant in the next 18 months. Females of child-bearing potential must use an acceptable method of contraception during trial participation.

发起方