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OpenTrials
Completed

NCT Number: NCT01121159

Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants

Accuracy of posttraumatic orbital reconstruction of the medial orbital wall and/or floor is better with preoperatively preformed orbital implants than with non-preformed orbital implants.

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Key information

Conditions

Orbital Floor Fracture Medial Orbital Wall Fracture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Hochschule Hannover, Hanover, Lower Saxony, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 18 years
  • Fracture (not older than 14 days) of the medial orbital wall and/or the orbital floor
  • Scheduled for reconstruction surgery with one of the following implants:
  • MatrixMIDFACE Preformed Orbital Plate
  • Custom-made orbital implant
  • Orbital Floor Mesh Plate
  • SynPOR Titanium Reinforced Fan Sheet
  • At least partial sight in both eyes before the accident
  • Willingness and ability to participate in the study follow-up according to the protocol
  • Ability to understand and read local language at elementary level
  • Signed informed consent

Exclusion criteria

  • Bilateral orbital fracture
  • Fractures of the orbital roof
  • Comminuted zygoma fracture
  • More than one piece fracture of the intraorbital bone lateral to the inferior orbital fissure
  • Previous dislocated orbital fractures on either side
  • Vision or diplopia not assessable
  • Injury of the globe
  • Neurological diseases with influence on eye motility or sight
  • Legal incompetence
  • Active malignancy
  • Life-threatening condition
  • Alcohol and drug abuse

Treatment and study plan

orbital fracture repair

Procedure

All patients will receive orbital fracture repair with one of the 4 specified implants

Primary outcomes

  1. shape and volume assessing software

    Time frame: up to 3 days after surgery

    A post-op CT or CBCT scan will be analyzed with specially developed software that can compare shape and volume of the reconstruced orbit to the uninjured orbit.

Secondary outcomes

  1. shape and volume assessing software

    Time frame: up to 3 days after surgery

    6 specific points and regions in the orbit will be compared between the reconstructed and the non-affected orbit

  2. Clinical tests to assess vision

    Time frame: up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery

    Globe position, visual acuity, bulbus motility and diplopia will be assessed with clinical tests

  3. Rate of complications

    Time frame: up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery

    Complications will be documented at every follow-up

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Official study title

A Prospective Multicenter Study to Compare the Accuracy of Posttraumatic Orbital Reconstruction of the Medial Orbital Wall and/or the Orbital Floor With Preoperatively Preformed Versus Non-preformed Orbital Plates

Acronym: Orbita 3

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 12, 2010
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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