Prospective Biomechanical Analysis of Donor-site Morbidity Following Microvascular Fibula Transplantation

Prospective Biomechanical Analysis of Donor-site Morbidity Following Microvascular Fibula Transplantation in 27 Consecutive Cases: a Clinical Cohort Study.

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

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Procedure: Fibula Explantation

Detailed Description

27 patients are examined before and after microsurgical fibula flap performed at the Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg Eppendorf, Germany.

• Study Type: Observational
• Enrollment (Actual): 27

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AOFAS Score	Objective and Subjective Score for functionality and pathology of the ankle region	1 day before fibula transplantation and 8.3 months postoperatively on average
Balance Test	Functional Assessment on Leonardo Mechanograph GFRP, measures the patients' stability	1 day before fibula transplantation and 8.3 months postoperatively on average
Range of Motion	Measuring Ankle Motion before and after surgery with a goniometer	1 day before fibula transplantation and 8.3 months postoperatively on average

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: October 7, 2014
• First Submitted That Met QC Criteria: October 10, 2014
• First Posted (Estimate): October 16, 2014

Study Record Updates

• Last Update Posted (Estimate): October 16, 2014
• Last Update Submitted That Met QC Criteria: October 10, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: UKEppendorfMKG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No