DRKS00006549
Recruiting
未知
se of patient-specific implants by means of Computer- Assisted Planning in Craniomaxillofacial Reconstruction. - PSI CAP
Medizinische Hochschule Hannover0 sites60 target enrollmentAugust 1, 2014
ConditionsMalignat neoplasm of the gum, ffracture of mandible, fracture of orbital floor, Neoplasm of unknown or uncertain behavior of oral cavity or digestive organs, malignat neoplasm without specification of site, Other malignant neoplasm of skin, Malinant neoplasm of other and unspecified parts of the mouth, benign neoplasm of bone and articular cartilage, Dentofacial anomalies (including malocclusion), Other dieseases of jawsS02K10K07D48D16D37C06C44C80C03Fracture of skull and facial bonesOther diseases of jawsDentofacial anomalies [including malocclusion]Neoplasm of uncertain or unknown behaviour of other and unspecified sitesBenign neoplasm of bone and articular cartilageNeoplasm of uncertain or unknown behaviour of oral cavity and digestive organsMalignant neoplasm of other and unspecified parts of mouthOther malignant neoplasms of skinMalignant neoplasm, without specification of siteMalignant neoplasm of gum
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Malignat neoplasm of the gum, ffracture of mandible, fracture of orbital floor, Neoplasm of unknown or uncertain behavior of oral cavity or digestive organs, malignat neoplasm without specification of site, Other malignant neoplasm of skin, Malinant neoplasm of other and unspecified parts of the mouth, benign neoplasm of bone and articular cartilage, Dentofacial anomalies (including malocclusion), Other dieseases of jaws
- Sponsor
- Medizinische Hochschule Hannover
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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