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

Not Applicable

Recruiting

Conditions: C80
C03
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
S02
K10
K07
D48
D16
D37
C06

Registration Number: DRKS00006549

Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

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
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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ideal 3-dimensional position of the implant (yes/ no)<br><br>Up to the time of last patient inclusion, the aquired data will be evaluated due the following aspects:<br>Does show the postoperative CT-data set have the same position as preoperative planned or are there aberances?<br><br>We compare this dataset with the preoperative planned data while merging the new (post-Op) -CT slices with the old thus planned dataset. We want to analyze if there is any nominal-actual value difference. For this analysis we use special software tools. Some important points are the deviation of orbital values, Axes and angles. Due to minimize the bias concerning the evaluation, we developed a standard method to evaluate this data.<br><br><br>

Secondary Outcome Measures