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.
Verified date | October 2014 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
Pre- and postoperatively patients who underwent free fibula flap were examined regarding donor-site morbidity of the lower extremities.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
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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