Cranioplasty Clinical Trial
Official title:
Comparison of Individual CAD/CAM-based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty - a Randomized Multicenter Clinical Trial
The purpose of this study is to compare the results of cranioplasty with CAD/CAM (computer aided design/manufactured) based Hydroxylapatite and Titanium implants in respect to infections, re-operations, antibiotic treatment or removal of the implant.
Status | Terminated |
Enrollment | 53 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Skull defects without the possibility to be covered with the missing own bone 2. Size of the defect = 16 cm2 3. Age = 18 4. Written informed consent of the patient Exclusion Criteria: 1. Active tumor 2. ASA 4 classification 3. Allergic disposition to ceramic or titanium 4. Concomitant participation in other clinical trials 5. Pregnant or nursing women 6. Expected low compliance 7. HIV positive 8. Active drug abuses |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Universität Leipzig KöR Medizinische Fakultät Klinik für Neurochirurgie | Leipzig | Sachsen |
Lead Sponsor | Collaborator |
---|---|
University of Leipzig | Universitätsklinikum Leipzig |
Germany,
Eufinger H, Weihe S, Scherer P, Rasche C, Wehmöller M. Management of cranial and craniofacial bone defects with prefabricated individual titanium implants: follow-up and evaluation of 166 patients with 169 titanium implants from 1994 to 2000. Int. J. CARS 2006; 1: 197-203
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the rate of local and/or systemic infections (acute/chronic) in both study arms within the first 6 months after operation. | 6 months | Yes | |
Secondary | Comparison of the rate of re-operations with and without ex-plantation of the implant in both arms. | 6 months | Yes | |
Secondary | Comparison of post-operative computer tomography (CT) (native and bone 5 mm) within 48 h in respect to bleeding, dislocation and further complications after cranioplasty in both arms. | 48 hours post-operative | Yes | |
Secondary | Comparison of health-related quality of life after cranioplasty in both arms using the SF36-questionnaire. | 6 months | No | |
Secondary | Comparison between both groups referring to cosmetic result, period of hospitalization, costs, intra-operative features. | 6 months | No | |
Secondary | Comparison of temperature sensitivity (cold/heat) six months after implantation in both groups. | 6 months | No | |
Secondary | Description of osteointegration with CT and bone scan six months post-operative in both groups | 6 months | No |
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