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Completed

NCT Number: NCT01147315

ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution

The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.

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Key information

Conditions

Mandible Osteoradionecrosis Radiation Injuries Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital, Nantes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (between 18 and 75 years) affiliated with an appropriate social security system, diagnosed as suffering from symptomatic ORN, radiologically confirmed, for which surgery is indicated
  • Presence maximum of 2 outbreaks of ORN
  • Oncological remission of the original tumor site for 1 year and for 3 years if the ORN is in the contact or close to the initial tumoral site
  • ECOG performance status 0, 1 or 2
  • ORN symptomatic accessible to the conservation of at least one cortical mandibular basilar
  • Signed informed consent

Exclusion criteria

  • Oncological treatment
  • Haematologic background
  • Current bone necrosis consecutive or concurrent to taking bisphosphonates
  • Extension of ORN does not allow the retention of a mandibular rod (bicortical form)
  • Presence of fracture complicating ORN
  • Bisphosphonates during the last year
  • Contraindications to the removal of iliac or sternum bone marrow
  • Contraindication for general anesthesia

Treatment and study plan

Hybrid bone substitution

Procedure

The patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis

Primary outcomes

  1. The cure of ORN

    Time frame: 12 months

Secondary outcomes

  1. Evaluation of post operative pain at mandibular and bone marrow sampling site

  2. Quality of life

  3. Possibility of secondary dental prosthetic devices

  4. CT semiology description of the treated area

  5. Bone regeneration

    Bone regeneration: kinetics of formation of new bone and biomaterial resorption

  6. Number of hospital days

  7. Safety of hybrid bone substitution

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

10 Patients Bicentric Prospective Study of Hybrid Bone Substitution With Calcium-phosphate Ceramic Biomaterial and Autologous Bone Marrow for Mandibular Osteoradionecrosis (ORN) Treatment

Acronym: ORN

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Jun 22, 2010
Registry last updated
Apr 6, 2018

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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