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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of Leipzig.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Klinik für Neurochirurgie Universitatsklinikum Leipzig AöR
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00923793
First received: June 17, 2009
Last updated: July 15, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Skull Defects
Cranioplasty
Device: Titanium implant (CranioConstruct™)
Device: Hydroxylapatite (CustomBone)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Individual CAD/CAM-based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty - a Randomized Multicenter Clinical Trial

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison of the rate of re-operations with and without ex-plantation of the implant in both arms. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Comparison of health-related quality of life after cranioplasty in both arms using the SF36-questionnaire. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Comparison between both groups referring to cosmetic result, period of hospitalization, costs, intra-operative features. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Comparison of temperature sensitivity (cold/heat) six months after implantation in both groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Description of osteointegration with CT and bone scan six months post-operative in both groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Titanium
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™)
One to three weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Titanium implant is ordered.
Other Name: CranioConstruct™
Experimental: Hydroxylapatite
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)
Six to eight weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Hydroxylapatite implant is ordered.
Other Name: CustomBone

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923793

Contacts
Contact: Dirk Lindner, Dr. med. 341-9717500 ext 0049 dlind@medizin.uni-leipzig.de
Contact: Marizel Schwarzkopf, Dr. sc. nat. 341 9716254 ext 0049 marizel.schwarzkopf@kksl.uni-leipzig.de

Locations
Germany
Universität Leipzig KöR Medizinische Fakultät Klinik für Neurochirurgie Recruiting
Leipzig, Sachsen, Germany, 04107
Contact: Dirk Lindner, Dr. med.    341-9717500 ext 0049    dlind@medizin.uni-leipzig.de   
Contact: Marizel Schwarzkopf, Dr. sc. nat.    3419716254 ext 0049    marizel.schwarzkopf@kksl.uni-leipzig.de   
Principal Investigator: Dirk Lindner, Dr. med.         
Sponsors and Collaborators
University of Leipzig
Klinik für Neurochirurgie Universitatsklinikum Leipzig AöR
Investigators
Study Director: Dirk Lindner, Dr. med. Universität Leipzig KöR Medizinische Falkutät Klinif für Neurochirurgie
  More Information

Publications:
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

Responsible Party: Dr. med. Dirk Lindner, Universität Leipzig AöR Klinik für Neurochirurgie
ClinicalTrials.gov Identifier: NCT00923793     History of Changes
Other Study ID Numbers: CustomBone vs. Titanium
Study First Received: June 17, 2009
Last Updated: July 15, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:
skull defects
Hydroxylapatite implant
Titanium implant
calotte defects without the possibility to be covered with the missing own bone

ClinicalTrials.gov processed this record on September 18, 2014