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Clinical Trials/DRKS00017312
DRKS00017312
Recruiting
未知

Comparison of TriLock Bridging Plates with conventional Bridging plates in the context of complex mandibular reconstruction – a pilot study - TriLock Bridging plates for mandibular reconstruction

Department of Oral and Maxillofacial Surgery, Medical University of Graz0 sites40 target enrollmentDecember 13, 2019
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ConditionsC41.1K10.2S02.64S02.65MandibleInflammatory conditions of jaws

Overview

Phase
未知
Intervention
Not specified
Conditions
C41.1
Sponsor
Department of Oral and Maxillofacial Surgery, Medical University of Graz
Enrollment
40
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 13, 2019
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Department of Oral and Maxillofacial Surgery, Medical University of Graz

Eligibility Criteria

Inclusion Criteria

  • •Male/female patients, requiring segmental mandibular reconstruction due to various inevitable medical reasons with the aid of mandibular reconstruction plates including:
  • •\- Severe mandibular trauma
  • •\- Osteonecrosis of the jaw
  • •\- Malignant tumorous disease involving the resection of the mandible
  • •\- Age range: 18\-85y
  • •\- Written consent of the participant after being informed

Exclusion Criteria

  • •Non\-compliant patients
  • •Medical causes
  • •\- Contraindications according to the manufacturer’s IFU
  • •\- Severe mandibular trauma without segmental mandibular reconstruction
  • •\- Mandibular tumour resection, without segmental mandibular resection.
  • •\- Mandibular resection, due to osteonecrosis of the jaw, without segmental mandibular resection.
  • •\- Limited anaesthesiologic fitness, which does not allow for elaborate reconstructive mandibular procedures.
  • •\- Pregnancy
  • •Informed Consent
  • •\- Patients, who meet the inclusion criteria, but do not wish to participate in the trial, cannot be enrolled to the study

Outcomes

Primary Outcomes

Not specified

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