se of patient-specific implants by means of Computer- Assisted Planning in Craniomaxillofacial Reconstruction. - PSI CAP

Medizinische Hochschule Hannover0 个研究点目标入组 60 人开始时间: 2014年8月1日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•older than 18 years till 99 years, reconstruction after ablative tumor surgery/ traumatically injury (pre-operativ true to original
•planning), intraoperative image- controlled tumor-defect-/ trauma reconstruction, existence of a pre-surgery CT or/ and FaceScan, patient letter of agreement, positive ethical review commitment, conformed clinical trial, adequate follow-up care and examination.
•column mandible
•indication for mandible fraction- resection
•column orbita
•before trauma or tumour resection: existing vision at the affected eye, indication for

•Key exclusion criteria column mandible:
•a. pre-existing infection
•b. unstable blood circulation to the skin and oral mucosa covering the implanted material
•c. inflexibility in the skin and oral mucosa covering the implanted material
•d. any disease or abnormality contraindicating bone graft or surgery in general
•e. Legal incompetence
•f. Life- threatening condition
•g. Alcohol and drug abuse that prevents from a reliable study participation
•Key exclusion criteria column orbita:
•a. Bilateral orbital fracture
•b. Fractures of the orbital roof
•c. Complex zygoma fracture
•d. Previous dislocated orbital fractures on either side
•e. Vision or dipoplia not assessable
•f. Injury to the globe that restricts surgical reconstruction (eg, Retinal detachment, globe rupture, …)
•g. Neurological diseases with influence on eye motility or sight
•h. Legal incompetence
•i. Life- threatening condition
•j. Alcohol and drug abuse that prevents from a reliable study participation

发起方

Medizinische Hochschule Hannover