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Completed

NCT Number: NCT00213837

Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis

This trial will study the reconstruction of the anterior part of the mandible and the adjacent soft tissue parts by a mandibular prosthesis made in porous titanium, associated or not, to a latissimus dorsi or pectoral flap, to avoid reconstruction with free microanastomosed bone flaps that are often associated with important morbidity.

The implant is consolidated by two prolonged parallel plates of titanium, allowing their fixation to the bone, easy to fix in a short time.

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Key information

Conditions

Otorhinolaryngologic Diseases Cranial Nerve Diseases Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Vagus Nerve Diseases Vocal Cord Paralysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre

Strasbourg, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female more than 18 years old

Exclusion criteria

  • Age less than 18 years old
  • Pregnant women
  • Local carcinoma excluding radiotherapic or surgical control
  • Poor general condition
  • Contraindication to general anesthesia
  • Uncontrolled diabetes

Treatment and study plan

Mandibular prosthesis made of a new highly biointegratable material

Device

Replacement of mandibular bone after partial or total mandible resection,avoiding then bone grafting. The porous titanium prosthesis is implanted under general anaesthesia in laryngeal surgeries. Bone resection and prosthesis placement is performed during the same surgical intervention. The prosthesis is attached onto the healthy bone with surgical screws. Simultaneous grafting of vascularised tissues may be done if the prosthesis surrounding area has been strongly irradiated.

Primary outcomes

  1. TEP scan + MRI + CT scan

    Time frame: 3 months after surgery

  2. Blood analysis (interleukin)

    Time frame: 8, 15, 30 days and 3 months after surgery

  3. All types of complication

    Time frame: 8, 15, 30 days, 3, 6 months after surgery and then every 6 months during the whole trial

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Dec 22, 2025

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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