Clinical trial NCT02228057: Long Term Patency Following Arterial Repair
Official title: Long Term Patency Following Arterial Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Extremity Arterial Surgery
Keywords: arterial patency
upper extremity
anastomosis
sensibility
pain
cold intolerance
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients that underwent upper extremity arterial surgery and are at least 6 months out of surgery.

Brief summary: 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.

Detailed description: Vascular injuries of the extremities can result from fractures, severe crush injuries, lacerations, and even iatrogenic causes, such as surgical interventions. Its prevalence is about 3% in the general population with increased incidence during times of war. Patients affected by vascular injuries can have significant morbidities, including cold intolerance, pain, sensory abnormalities, and weakness of the affected limb. Even after repair of the affected artery, patients may still experience paresthesias, motor function abnormalities and pain and cold intolerance. These symptoms are particularly relevant in the case of arm arterial repairs because this repair directly affects the function of the hand. Different techniques of arterial repair have evolved over time. Venous grafts (i.e. saphenous and dorsal hand veins) can be employed to repair the damaged vessel. Although most appropriate for treating long gaps, vein grafts have several disadvantages. There is often a diameter mismatch between the harvested vein and the damaged artery which can compromise the repair site. Furthermore, veins are more compliant and have higher volume storage capabilities than their arterial counterparts. These inherent venous qualities can alter blood flow to the limb causing stasis, turbulence, and eventually, stenosis of the graft. Other methodologies have been developed in an effort to balance the negatives associated with venous grafting, including synthetic graft use, arterial ligation, end-to-side anastomosis, and end-to-end repair. Despite available interventions and advances in microsurgical technique, arterial repair in the arm, can still result in significant functional impairment of the upper extremity. The hand is highly perfused with a dual arterial system that arches across the dorsal and palmar surface of the hand. Once an upper extremity artery is compromised, a surgeon's primary goal is to restore blood flow to the hand so as to prevent impairment. Despite a surgeon's best efforts, long term (greater than 6 months) outcomes are hard to predict. Furthermore, the patency rates of the arterial repair have been consistently reported at approximately 50%. We believe that the long term patency of the upper extremity artery has a direct effect on a patient's perceived pain and cold intolerance, sensibility, and motor function of the hand. Our hypothesis is that repaired arteries in the upper extremity will have an occlusion rate of 50% in the long term (greater than 6 months post-surgery) and that this occlusion is responsible for motor and sensory function abnormalities, pain, and cold-intolerance. We will use high resolution duplex Doppler ultrasound to investigate occlusion rates of repaired arteries and compare those to the unaffected contralateral arteries (internal control). 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, cold intolerance, 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.

Eligibility criteria: Inclusion Criteria:

Patients meeting the following criteria will be eligible to participate in this study:

1. Age 18 and over
2. Able to provide informed consent
3. Have previously underwent surgery for an arm arterial repair
4. Be at least 6 months post-arterial repair
5. Willing and able to comply with follow-up tests/procedures and questionnaires

Exclusion Criteria:

Patients meeting the following criteria will be excluded from this study:

1. Age less than 18 years
2. Unable to provide informed consent
3. Nerve repair in extremity of interest
4. Any condition which compromises the contralateral hand to serve as a reliable internal control

Primary outcomes:
measure: relationship of time after arterial repair with patency of the vessel
timeFrame: at least 6 months after surgery
Secondary outcomes:
measure: Correlation between arterial patency and cold intolerance.
timeFrame: at least 6 months after surgery
measure: Correlation between arterial patency and digital sensibility.
timeFrame: at least 6 months after surgery
measure: Correlation between arterial patency and hand strength.
timeFrame: at least 6 months after surgery
measure: Correlation between arterial patency and capillary refill
timeFrame: at least 6 months after surgery
measure: Correlation between arterial patency and range of movement of the fingers
timeFrame: at least 6 months after surgery
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Scaife Hall
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Alexander M. Spiess, MD
role: PRINCIPAL_INVESTIGATOR
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