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Clinical Trials/NCT02265991
NCT02265991
Completed
Not Applicable

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

Universitätsklinikum Hamburg-Eppendorf0 sites27 target enrollmentSeptember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Complications
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
27
Primary Endpoint
Change in Esslinger Fitness Index
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
June 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carsten Rendenbach

Resident, Researcher

Universitätsklinikum Hamburg-Eppendorf

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Esslinger Fitness Index

Time Frame: 1 day before fibula transplantation and 8.3 months postoperatively on average

Jumping Mechanography, Functional Assessment on Leonardo Mechanograph GFRP

Secondary Outcomes

  • Range of Motion(1 day before fibula transplantation and 8.3 months postoperatively on average)
  • 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)

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