Clinical trial NCT00923793: Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty
Official title: Comparison of Individual CAD/CAM-based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty - a Randomized Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Skull Defects
Cranioplasty
Keywords: skull defects
Hydroxylapatite implant
Titanium implant
calotte defects without the possibility to be covered with the missing own bone
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Leipzig
First posted: 2009-06-18
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the rate of local and/or systemic infections (acute/chronic) in both study arms within the first 6 months after operation.
timeFrame: 6 months
Secondary outcomes:
measure: Comparison of the rate of re-operations with and without ex-plantation of the implant in both arms.
timeFrame: 6 months
measure: 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.
timeFrame: 48 hours post-operative
measure: Comparison of health-related quality of life after cranioplasty in both arms using the SF36-questionnaire.
timeFrame: 6 months
measure: Comparison between both groups referring to cosmetic result, period of hospitalization, costs, intra-operative features.
timeFrame: 6 months
measure: Comparison of temperature sensitivity (cold/heat) six months after implantation in both groups.
timeFrame: 6 months
measure: Description of osteointegration with CT and bone scan six months post-operative in both groups
timeFrame: 6 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Universität Leipzig KöR Medizinische Fakultät Klinik für Neurochirurgie
state: Sachsen
Study officials:
affiliation: Universität Leipzig KöR Medizinische Falkutät Klinif für Neurochirurgie
name: Dirk Lindner, Dr. med.
role: STUDY_DIRECTOR
References:
citation: 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
citation: Lindner D, Schlothofer-Schumann K, Kern BC, Marx O, Muns A, Meixensberger J. Cranioplasty using custom-made hydroxyapatite versus titanium: a randomized clinical trial. J Neurosurg. 2017 Jan;126(1):175-183. doi: 10.3171/2015.10.JNS151245. Epub 2016 Feb 26.