NCT05742932

Brief Summary

This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK/MICROTEK®) used for trauma surgery.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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 Progress93%
Mar 2023Aug 2026

First Submitted

Initial submission to the registry

February 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

March 7, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

February 15, 2023

Last Update Submit

January 13, 2026

Conditions

Trauma InjuryMaxilla FractureMaxillofacial Trauma

Keywords

PerformanceSafetyScrewPlateMedical deviceTrauma surgeryCranio-maxillofacialGlobal D

Outcome Measures

Primary Outcomes (1)

  • Performance of the Global D's implants used for trauma surgery assessed by the evaluation of the functional jaw activity 6 months after the surgery

    The functional jaw activity will be evaluated with the Mandibular Function Impairment Questionnaire (MFIQ) 6 months after the surgery. This questionnaire have 17 items, that have to be answered with a Likert scale from 1 (No problem) to 5 (very hard or impossible).

    6 months

Secondary Outcomes (6)

  • Performance of the Global D implants used for trauma surgery - Outcome Measure 1

    6 months

  • Security of the Global D implants used for trauma surgery - Outcome Measure 2

    1 year

  • Security of the Global D implants used for trauma surgery - Outcome Measure 3

    6 months

  • Performance of the Global D implants used for trauma surgery - Outcome Measure 4

    6 months

  • Surgeon satisfaction on the implant's utilisation - Outcome Measure 5

    Immediately following surgery

  • +1 more secondary outcomes

Study Arms (1)

Study group

Male and female, major or minor patients. The patients have maxillary, mandibular, maxillomandibular fracture with/without annex face or skull fracture, and will be treated by trauma surgery.

Device: Trauma surgery using Global D's implants.

Interventions

Trauma surgery using Global D's implants.DEVICE

Major or minor participants who will be treated by an trauma surgery with ORTRAUTEK® or MINITEK/MICROTEK® implant(s).

Study group

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is composed of male and female, major or minor, who will be treated by trauma surgery. The patients will have maxillary, mandibular or maxillomandibular fractures with/without annex skull's or face's fractures.

You may qualify if:

  • Male or female patient, major or minor (11 years old minimum)
  • Patient undergoing surgery on the mandible and/or maxilla (mandatory), with or without associated facial fractures (orbit, upper two-thirds of the face, skull)
  • Patient with abilities to read, understand and answer to the study questionnaires.
  • Patient (and his legal representative if minor) who signed the study consent form.
  • Patient affiliated to a social security system.

You may not qualify if:

  • Patient allergic to one of the components of the implants
  • Patient with physical or mental inabilities that will compromise the follow-up during the study
  • Patient with acute or chronic infection (local or systemic)
  • Patients with bone's tumors in the anchorage area of the implant
  • Person on legal protection
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital de la Croix Rousse - Hospices Civils de Lyon (FRANCE)

Lyon, France

Location

Hopital Femme Mère Enfant - Hospices Civils de Lyon (FRANCE)

Lyon, France

Location

MeSH Terms

Conditions

Accidental InjuriesMaxillary Fractures

Condition Hierarchy (Ancestors)

Wounds and InjuriesJaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, Bone

Study Officials

  • Julie Chauvel-Picard, MD

    Cranio-maxillofacial surgeon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 24, 2023

Study Start

March 7, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations

FR(2)