NCT00923793

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

4.8 years

First QC Date

June 17, 2009

Last Update Submit

May 20, 2015

Conditions

Skull DefectsCranioplasty

Keywords

skull defectsHydroxylapatite implantTitanium implantcalotte defects without the possibility to be covered with the missing own bone

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

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

    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.

    48 hours post-operative

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

    6 months

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

    6 months

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

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Titanium

ACTIVE COMPARATOR

Titanium implant for cranioplasty. Titanium implants are used since 10 years in Germany because of their high biocompatibility and accuracy of fit.

Device: Titanium implant (CranioConstruct™)

Hydroxylapatite

EXPERIMENTAL

Hydroxylapatite (CustomBone) implant Hydroxylapatite implants are used since about 3 years in Germany. As this material is very similar to human bone structure an improved osteointegration has been observed.

Device: Hydroxylapatite (CustomBone)

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.

Also known as: CranioConstruct™
Titanium
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.

Also known as: CustomBone
Hydroxylapatite

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Skull defects without the possibility to be covered with the missing own bone
  • Size of the defect ≥ 16 cm2
  • Age ≥ 18
  • Written informed consent of the patient

You may not qualify if:

  • Active tumor
  • ASA 4 classification
  • Allergic disposition to ceramic or titanium
  • Concomitant participation in other clinical trials
  • Pregnant or nursing women
  • Expected low compliance
  • HIV positive
  • Active drug abuses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universität Leipzig KöR Medizinische Fakultät Klinik für Neurochirurgie

Leipzig, Saxony, 04107, Germany

Location

Related Publications (2)

  • 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

    BACKGROUND

  • 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.

    PMID: 26918471DERIVED

Study Officials

  • Dirk Lindner, Dr. med.

    Universität Leipzig KöR Medizinische Falkutät Klinif für Neurochirurgie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 18, 2009

Study Start

June 1, 2009

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations

DE(1)