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Completed

NCT Number: NCT02265991

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

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

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibula Explantation

Procedure

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

Other names: Free fibula flap, autologous fibula transfer

Primary outcomes

  1. 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

  1. AOFAS Score

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

    Objective and Subjective Score for functionality and pathology of the ankle region

  2. Balance Test

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

    Functional Assessment on Leonardo Mechanograph GFRP, measures the patients' stability

  3. Range of Motion

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

    Measuring Ankle Motion before and after surgery with a goniometer

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 16, 2014
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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