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

Phase 3TerminatedNCT00923793

University of Leipzig53 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skull Defects Cranioplasty

Interventions

Titanium implant (CranioConstruct™)DEVICE

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)DEVICE

Six to eight weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Hydroxylapatite implant is ordered.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Universität Leipzig KöR Medizinische Fakultät Klinik für Neurochirurgie

Leipzig, Saxony, Germany

Outcomes

Primary Outcomes

Comparison of the rate of local and/or systemic infections (acute/chronic) in both study arms within the first 6 months after operation.

Time frame: 6 months

Secondary Outcomes

Comparison of the rate of re-operations with and without ex-plantation of the implant in both arms.

Time frame: 6 months

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.

Time frame: 48 hours post-operative

Comparison of health-related quality of life after cranioplasty in both arms using the SF36-questionnaire.

Time frame: 6 months

Comparison between both groups referring to cosmetic result, period of hospitalization, costs, intra-operative features.

Time frame: 6 months

Comparison of temperature sensitivity (cold/heat) six months after implantation in both groups.

Time frame: 6 months

Description of osteointegration with CT and bone scan six months post-operative in both groups

Time frame: 6 months

Data from ClinicalTrials.gov

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