We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional Impact of Reconstructive Surgery by Harvesting a Vascularized Free Fibula Flap Postoperatively. (FIBULAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05641597
Recruitment Status : Recruiting
First Posted : December 7, 2022
Last Update Posted : December 7, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The fibula is a leg bone that can be used in complex bone reconstruction by reconstructive surgery. This innovative surgical procedure is increasingly used in complex facial (mandibular) reconstructions following cancer and trauma involving a bone segment. Following this surgery, chronic pain and post-operative complications can occur, with a functional impact on locomotion, leading to instability, ankle stiffness and a risk of falls. The causes of functional deficits following surgery remain complex and difficult to objectivate by clinical examination alone. However, these deficits need to be better evaluated to develop specific therapeutic targets that will allow the implementation of a personalized postoperative rehabilitation. At present, no study has been performed to objectively quantify the short- and medium-term functional repercussions of the operation.

This study proposes, for the first time, to quantify the repercussions on muscular and locomotor functions as well as the quality of life after reconstructive surgery by transfer of a free vascularized fibula flap in the short and medium term (1 month and 6 months postoperatively).

This is a biomedical, interventional study, which will take place on the Technological Investigation Platform (PIT) located on the garden level of the Rehabilitation Center (C2R) of the Dijon Bourgogne University Hospital, 35 participants will be included in this study over a period of 36 months. For this study, you will be followed for about 7 months, during 3 obligatory visits


Condition or disease Intervention/treatment Phase
Bone Reconstruction by Free Fibula Flap Other: Actimetric measurement Other: Evaluation of plantar flexion, dorsal flexion and ankle eversion forces Other: Assessment of static and dynamic balance and quality of life Other: Functional gait assessment (TM6) Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Functional Impact of Postoperative Vascularized Free Fibula Flap Harvesting Repair Surgery. Prospective Pilot Study
Actual Study Start Date : November 15, 2022
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Other: Actimetric measurement
    Evaluation during 7 days "in real life condition Carried out during the pre-operative evaluation (M0), the post-operative evaluation (M1) and the post-operative evaluation (M6)
  • Other: Evaluation of plantar flexion, dorsal flexion and ankle eversion forces
    Performed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments
  • Other: Assessment of static and dynamic balance and quality of life
    Performed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments
  • Other: Functional gait assessment (TM6)
    Performed at the preoperative (M0), postoperative (M1) and postoperative (M6) assessments

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Maximum isometric force of plantar flexion of the foot on a dynamometer [ Time Frame: Change from pre-op and 6 months post-op ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients eligible for bone reconstruction with a free fibula flap
  • Age ≥ 18 years
  • Procedure scheduled in the plastic and maxillofacial surgery department of the Dijon University Hospital
  • Willingness to comply with the protocol requirements
  • Person having given oral, free and informed consent

Exclusion Criteria:

  • Person who is not affiliated or not a beneficiary of a social security system
  • Person subject to a legal protection measure (curatorship, guardianship)
  • Person subject to a legal protection measure
  • Pregnant, parturient or breastfeeding woman
  • Major who is incapable or unable to give oral consent
  • Minor
  • Indication for bone reconstruction of a lower limb (e.g. femur) or pelvis
  • Musculoskeletal or neurological disorders causing significant prior impairment of walking (whatever the etiology)
  • Cognitive disorders that prevent the proper understanding of instructions and the completion of questionnaires
  • Non operated patient
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05641597


Contacts
Layout table for location contacts
Contact: David GUILLIER 0380293757 david.guillier@chu-dijon.fr

Locations
Layout table for location information
France
Chu Dijon Bourgogne Recruiting
Dijon, France, 21000
Contact: David GUILLIER    0380293757    david.guillier@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT05641597    
Other Study ID Numbers: GUILLIER AOI 2021
First Posted: December 7, 2022    Key Record Dates
Last Update Posted: December 7, 2022
Last Verified: December 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No