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NCT02265991 Clinical Trial

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

Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02265991
Other study ID # UKEppendorfMKG
Secondary ID
Status Completed
Phase N/A
First received October 7, 2014
Last updated October 10, 2014
Start date September 2011
Est. completion date June 2014

Study information
Verified date October 2014
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Fibula Explantation
surgical harvest of an osteomyocutaenous transplant consisting of a part of the fibula and surrounding soft tissues

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary Balance Test Functional Assessment on Leonardo Mechanograph GFRP, measures the patients' stability 1 day before fibula transplantation and 8.3 months postoperatively on average No
Secondary 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 No
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