NCT02265991

Brief Summary

Pre- and postoperatively patients who underwent free fibula flap were examined regarding donor-site morbidity of the lower extremities.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 16, 2014

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

2.8 years

First QC Date

October 7, 2014

Last Update Submit

October 10, 2014

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Change in Esslinger Fitness Index

    Jumping Mechanography, Functional Assessment on Leonardo Mechanograph GFRP

    1 day before fibula transplantation and 8.3 months postoperatively on average

Secondary Outcomes (3)

  • AOFAS Score

    1 day before fibula transplantation and 8.3 months postoperatively on average

  • Balance Test

    1 day before fibula transplantation and 8.3 months postoperatively on average

  • Range of Motion

    1 day before fibula transplantation and 8.3 months postoperatively on average

Interventions

Fibula ExplantationPROCEDURE

surgical harvest of an osteomyocutaenous transplant consisting of a part of the fibula and surrounding soft tissues

Also known as: Free fibula flap, autologous fibula transfer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with informed consent and that will undergo mandible resection and reconstruction via free fibula flap at the Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg Eppendorf, Germany.

You may qualify if:

  • Planned continuity interrupting mandible resection
  • Planned mandible reconstruction with free fibula flap
  • Informed consent
  • Procedure performed at University Medical Center Hamburg Eppendorf

You may not qualify if:

  • Preexisting pathology/disease of the lower limbs or back (angiologic, neurologic, orthopedic)
  • Musculosceletal pain at the time of study enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, Researcher

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 16, 2014

Study Start

September 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 16, 2014

Record last verified: 2014-10