NCT00925509

Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aero digestive Cancer patients treated by external head and neck radiotherapy and/or by curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. The purpose of the study is to Investigate the accuracy of implants insertion in the anteroposterior way, using radiosurgical guidance.

Detailed description

* Investigate the accuracy of inserting implants in the vertical way and in angulation, on irradiated native mandible or on microanastomosed fibula flaps * Investigate the accuracy of inserting implants in the anteroposterior way, in the vertical way and in angulation for all the involved patients (meaning on irradiated native mandible or on microanastomosed fibula flaps) * Investigate the delay of mucous healing * Estimate the prosthetic function * Evaluate the osteonecrosis rate after radiation with traumatic etiology due to implantation * Estimate the implant rate due to minimally invasive flaps * Estimate the implant rate due to pure trans mucosa way * Estimate the post surgical therapeutic success after 1 year

Conditions

• Upper Digestive Tract Cancer

Interventions

Type	Name	Description
PROCEDURE	Therapeutic assessment -Radio-surgical guidance.	The first steps of the procedure include the production of a radiosurgical guide and the preparation of a mask in order to allow precise, non invasive repositioning of the guide. Secondarily, the patient undergoes a CT-scan with the mask on and the radiosurgical guide in place. This provisional scan is used for preimplantation evaluation and drilling of the guide hole. Under general anaesthesia, the mask is placed on the patient and the guide is fixed to the mask. A hole is drilled with a burr in the mandible through the hole in the guide. Implants are placed and the guide and mask are removed. A second, post-implantation CT-scan is planned 3 months after implantation. Comparison of pre- and post-implantation CT-scans allows to evaluate the precision of the placement.

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-06-22
• Last updated: 2011-06-22

Locations

4 sites across 1 country: France