Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00923793
• Other study ID #: CustomBone vs. Titanium
• Status: Terminated
• Phase: Phase 3
• First received: June 17, 2009
• Last updated: May 20, 2015
• Start date: June 2009
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Both implant materials for cranioplasty, Hydroxylapatite and Titanium, are CE certified medical devices used in common practices. This study is intended to get prospective data in addition to the empirical and retrospective existing ones to enable the decision on which implant material should be preferably employed in future.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cranioplasty
• Skull Defects

Intervention

Device:
• Titanium implant (CranioConstruct™)
One to three weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Titanium implant is ordered.
• Hydroxylapatite (CustomBone)
Six to eight weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Hydroxylapatite implant is ordered.

Locations

Country	Name	City	State
Germany	Universität Leipzig KöR Medizinische Fakultät Klinik für Neurochirurgie	Leipzig	Sachsen

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	Universitätsklinikum Leipzig

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

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