Long Term Patency Following Arterial Repair
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|ClinicalTrials.gov Identifier: NCT02228057|
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : February 13, 2015
Injury to the blood vessels of the extremities, and more specifically the arteries, can result from fractures and severe crush injuries. It occurs in about 3% of the general population. People affected by blood vessel injuries can have important problems, including cold intolerance, general pain, and weakened function of the associated limb. Even after surgical intervention to repair the affected artery, people may still experience numbness, problems with movement, and an inadequate supply of oxygen to the limb. These symptoms are particularly relevant in the case of forearm arterial repairs because this repair directly affects one of our most vital structures: the hand. Despite available interventions and advances in microsurgical technique, arterial repairs can still result in significant sensory and functional impairment of the hand. Once an artery within the arm is injured, a surgeon's primary goal is to restore blood flow to the hand and prevent functional impairment. Even with a prompt effort to restore hand perfusion, long-term (greater than 6 months) sensory and motor function is hard to predict.
Furthermore, sometimes the repaired artery becomes occluded over time. We believe that this occlusion has a direct impact on a patient's perceived pain and cold intolerance at the level of the hand.
In this study, we are investigating the occurrence of blood vessel occlusion in the arm after at least 6 months of surgery and the impact of this event. To assess this we will use physical exams, non-invasive tests, duplex doppler ultrasound and questionnaires. Questionnaires, including the DASH (disabilities of the arm, shoulder,and hand), CISS (Cold Intolerance Symptom Severity Questionnaire), and Michigan hand score, will be used to assess pain, sensory, and motor impairments in both the affected and unaffected hand. Functional assessments will include 2-point discrimination, grip strength, pinch strength, capillary refill and range of motion.
|Condition or disease|
|Upper Extremity Arterial Surgery|
|Study Type :||Observational|
|Actual Enrollment :||13 participants|
|Official Title:||Long Term Patency Following Arterial Repair|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
all patients who had upper extremity artery surgery at least 6 months ago
- relationship of time after arterial repair with patency of the vessel [ Time Frame: at least 6 months after surgery ]By using ultrasound, both the ulnar and radial artery will be visualized in both arms and using color ultrasound, we will detect the bloodflow. If no flow is present we will assume that the vessel is occluded.
- Correlation between arterial patency and cold intolerance. [ Time Frame: at least 6 months after surgery ]Both hands will be assessed for cold intolerance. To assess this we will use the CISS questionnaire (Cold Intolerance Symptom Severity Questionnaire).
- Correlation between arterial patency and digital sensibility. [ Time Frame: at least 6 months after surgery ]Both hands will be assessed for sensibility. To assess this we will use physical exams and questionnaires. Questionnaires, including the DASH (disabilities of the arm, shoulder,and hand) and Michigan hand score will be used to assess sensibility in both the affected and unaffected hand. A functional assessment for sensibility will be the 2-point discrimination.
- Correlation between arterial patency and hand strength. [ Time Frame: at least 6 months after surgery ]Functional assessments will include grip strength and pinch strength.
- Correlation between arterial patency and capillary refill [ Time Frame: at least 6 months after surgery ]Vascular assessment will include capillary refill.
- Correlation between arterial patency and range of movement of the fingers [ Time Frame: at least 6 months after surgery ]Functional assessments will include the measurement of the distance of the fingertips to the distal palmar crease when the fingers are maximally flexed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228057
|United States, Pennsylvania|
|University of Pittsburgh Scaife Hall|
|Pittsburgh, Pennsylvania, United States, 15261|
|Principal Investigator:||Alexander M. Spiess, MD||University of Pittsburgh|