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

Not Applicable

Recruiting

Conditions: C41.1
K10.2
S02.64
S02.65
Mandible
Inflammatory conditions of jaws

Registration Number: DRKS00017312

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

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

- Minors

Medical causes

- Contraindications according to the manufacturer’s IFU

- NYHA IV

- 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim of the trial is to compare the performance and intraoperative usability of the two plate designs (APPLICABILTY).<br> <br>Comparison between MODUS 2.5 Locking mandibular reconstruction plates and the MODUS 2.0 TriLock Bridging plate system in terms of the intraoperative usabiltiy of the plating systems.<br>Comparison between MODUS 2.5 Locking mandibular reconstruction plates and the MODUS 2.0 TriLock Bridging plate system in terms of the intraoperative adaptability of the plating systems.

Secondary Outcome Measures

Name	Time	Method
1. postoperative quality of life (SF-36)<br><br>1a. Preoperatively<br>1b. 6 months post op<br>1c. 12 months post op<br><br>2. Safety of the reconstruction plates