NCT00240669

Brief Summary

Primary objective : To evaluate the quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA compared with usual Titanium plates. Secondary objective :

  • To evaluate the resorbable device ergonomy versus Titanium.
  • To evaluate the clinical tolerance of resorbable device versus Titanium. Hypothesis : Osteosynthesis with resorbable device demonstrates a non inferiority success probability regarding the success observed in osteosynthesis with Titanium, with a less important probability of re-operation. Study duration : 14 months for each patient. Study treatment :
  • Group I : Resorbable device PLLA/PGA.
  • Group II : Titanium device. Study visits : \- Screening visit - Baseline with randomization and surgery - Day1 - Day 21 - Day 45(Traumatology)/Day 90 (orthognatic) - Month 6,12 and 14. Randomization : Stratification by centres, mono or bimaxillar surgery and traumatologic or orthognatic criteria.

Trial Health

55
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Trial Health Score

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

Enrollment
308

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

October 14, 2005

Last Update Submit

April 26, 2007

Conditions

Maxillo-Facial Surgery

Keywords

Maxillo facial surgery,osteosynthesis,resorbable device

Outcome Measures

Primary Outcomes (1)

  • The quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA will be evaluated by the notion of unperfect resuts.

Secondary Outcomes (8)

  • Evaluation of device ergonomy :

  • The operative time of each surgery will be monitored, to compare operative duration of operations ; the only variable will be the osteosynthesis method.

  • Clinical tolerance of the devices

  • pain (Visual Analogic Scale),

  • local inflammation,

  • +3 more secondary outcomes

Interventions

Resorbable device PLLA/PGADEVICE
Titanium deviceDEVICE

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \<Age\<50.
  • One or more fractures of facial massif requiring a surgical setting with osteosynthesis plates.
  • One or more osteotomy of facial massif requiring a surgical setting with osteosynthesis plates.
  • Orally and written informed patient. Patient willing to participate the study.
  • Signed informed consent.

You may not qualify if:

  • Any previous surgery at the same operative site.
  • Patient suffering from chronic affection which could interfere with bone consolidation.
  • Corticotherapy, immunosuppressive or anticonvulsant treatment or long term antibiotherapy.
  • Nursing or pregnant female.
  • Patient with a high risk of non compliance to sudy visits.
  • Unconscious patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pierre Bouletreau

Lyon, 69495, France

RECRUITING

Study Officials

  • Pierre BOULETREAU, MD

    Hospices Civile de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre BOULETREAU, MD

CONTACT

33 4 78 86 19 36pierre.bouletreau@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Start

November 1, 2005

Last Updated

April 27, 2007

Record last verified: 2007-04

Locations

FR(1)