Upper Extremity Arterial SurgeryNCT02228057
Long Term Patency Following Arterial Repair
An observational study of Upper Extremity Arterial Surgery, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Extremity Arterial Surgery
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients that underwent upper extremity arterial surgery and are at least 6 months out of surgery.
Who may be able to join
- Patients meeting the following criteria will be eligible to participate in this study:
- Age 18 and over
- Able to provide informed consent
- Have previously underwent surgery for an arm arterial repair
- Be at least 6 months post-arterial repair
- Willing and able to comply with follow-up tests/procedures and questionnaires
Who cannot join
- Patients meeting the following criteria will be excluded from this study:
- Age less than 18 years
- Unable to provide informed consent
- Nerve repair in extremity of interest
- Any condition which compromises the contralateral hand to serve as a reliable internal control
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Scaife Hall
Pittsburgh, Pennsylvania, 15261
About this study
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.
Read the 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.
- Conditions
- Upper Extremity Arterial Surgery
- Keywords
- arterial patency, upper extremity, anastomosis, sensibility, pain, cold intolerance
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| operated group | all patients who had upper extremity artery surgery at least 6 months ago |
What is being measured
The primary outcome is the main question the study is designed to answer.
relationship of time after arterial repair with patency of the vessel
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.
Measured: at least 6 months after surgery
Secondary outcomes (5)
Correlation between arterial patency and cold intolerance.
Both hands will be assessed for cold intolerance. To assess this we will use the CISS questionnaire (Cold Intolerance Symptom Severity Questionnaire).
Measured: at least 6 months after surgery
Correlation between arterial patency and digital sensibility.
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.
Measured: at least 6 months after surgery
Correlation between arterial patency and hand strength.
Functional assessments will include grip strength and pinch strength.
Measured: at least 6 months after surgery
Correlation between arterial patency and capillary refill
Vascular assessment will include capillary refill.
Measured: at least 6 months after surgery
Correlation between arterial patency and range of movement of the fingers
Functional assessments will include the measurement of the distance of the fingertips to the distal palmar crease when the fingers are maximally flexed.
Measured: at least 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity Arterial SurgeryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander M Spiess, MD, University of Pittsburgh
- Investigators
- Alexander M. Spiess, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228057
- Sponsor's protocol ID
- PRO12010024
- Status last verified
- Feb 2015
- First submitted
- 25 Aug 2014
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Knobloch K, Vogt PM. On "patency of radial arteries reconstructed after radial forearm flap harvest (J Reconstr Microsurg 2007;23:347-350)". J Reconstr Microsurg. 2009 Jan;25(1):77-8; author reply 79-80. doi: 10.1055/s-0028-1090602. Epub 2008 Oct 16. No abstract available.
PubMed 18925541Gelberman RH, Nunley JA, Koman LA, Gould JS, Hergenroeder PT, MacClean CR, Urbaniak JR. The results of radial and ulnar arterial repair in the forearm. Experience in three medical centers. J Bone Joint Surg Am. 1982 Mar;64(3):383-7.
PubMed 7061556Nunley JA, Goldner RD, Koman LA, Gelberman R, Urbaniak JR. Arterial stump pressure: a determinant of arterial patency? J Hand Surg Am. 1987 Mar;12(2):245-9. doi: 10.1016/s0363-5023(87)80280-0.
PubMed 3559079Lee RE, Obeid FN, Horst HM, Bivins BA. Acute penetrating arterial injuries of the forearm. Ligation or repair? Am Surg. 1985 Jun;51(6):318-24.
PubMed 3994174Deutinger M, Porenta G, Metz V, Kaliman J, Freilinger G. [Hemodynamic and clinical studies following injury of the arteries of the forearm]. Handchir Mikrochir Plast Chir. 1989 Nov;21(6):283-6. German.
PubMed 2606367Aftabuddin M, Islam N, Jafar MA, Haque E, Alimuzzaman M. Management of isolated radial or ulnar arteries at the forearm. J Trauma. 1995 Jan;38(1):149-51. doi: 10.1097/00005373-199501000-00033.
PubMed 7745646Daoutis N, Gerostathopoulos N, Bouchlis G, Efstathopoulos D, Misitzis D, Anagnostou S, Vasiliadiw A. Results after repair of traumatic arterial damage in the forearm. Microsurgery. 1992;13(4):175-7. doi: 10.1002/micr.1920130405.
PubMed 1495376Johnson M, Ford M, Johansen K. Radial or ulnar artery laceration. Repair or ligate? Arch Surg. 1993 Sep;128(9):971-4; discussion 974-5. doi: 10.1001/archsurg.1993.01420210031004.
PubMed 8368933Ge XZ, Huang GK. Use of distal arteries for microvascular reconstruction in forearm and hand surgery. Microsurgery. 1996;17(4):180-3. doi: 10.1002/(SICI)1098-2752(1996)17:43.0.CO;2-P.
PubMed 9140949Hentschel M, Rucker G. [Treatment of arterial injuries of the forearm and hand]. Handchirurgie. 1970;2(1):18-21. No abstract available. German.
PubMed 5538419Stricker SJ, Burkhalter WE, Ouellette AE. Single-vessel forearm arterial repairs. Patency rates using nuclear angiography. Orthopedics. 1989 Jul;12(7):963-5. doi: 10.3928/0147-7447-19890701-08.
PubMed 2771822Gelberman RH, Blasingame JP, Fronek A, Dimick MP. Forearm arterial injuries. J Hand Surg Am. 1979 Sep;4(5):401-8. doi: 10.1016/s0363-5023(79)80031-3.
PubMed 501048Rothkopf DM, Chu B, Gonzalez F, Borah G, Ashmead D 4th, Dunn R. Radial and ulnar artery repairs: assessing patency rates with color Doppler ultrasonographic imaging. J Hand Surg Am. 1993 Jul;18(4):626-8. doi: 10.1016/0363-5023(93)90305-M.
PubMed 8349969
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Patency Following Arterial Repair
- ClinicalTrials.gov ID
- NCT02228057
- Acronym / sponsor ID
- PRO12010024
- Conditions
- Upper Extremity Arterial Surgery
- Keywords
- arterial patency, upper extremity, anastomosis, sensibility, pain, cold intolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| operated group | – | –all patients who had upper extremity artery surgery at least 6 months ago |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients that underwent upper extremity arterial surgery and are at least 6 months out of surgery.
Key inclusion criteria (6 listed)
- Age 18 and over
- Able to provide informed consent
- Have previously underwent surgery for an arm arterial repair
- Be at least 6 months post-arterial repair
- Willing and able to comply with follow-up tests/procedures and questionnaires
Key exclusion criteria (5 listed)
- Age less than 18 years
- Unable to provide informed consent
- Nerve repair in extremity of interest
- Any condition which compromises the contralateral hand to serve as a reliable internal control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Correlation between arterial patency and cold intolerance.
Time frame: at least 6 months after surgery
Correlation between arterial patency and digital sensibility.
Time frame: at least 6 months after surgery
Correlation between arterial patency and hand strength.
Time frame: at least 6 months after surgery
Correlation between arterial patency and capillary refill
Time frame: at least 6 months after surgery
Correlation between arterial patency and range of movement of the fingers
Time frame: at least 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
- Background: PubMed 18925541Knobloch K, Vogt PM. On "patency of radial arteries reconstructed after radial forearm flap harvest (J Reconstr Microsurg 2007;23:347-350)". J Reconstr Microsurg. 2009 Jan;25(1):77-8; author reply 79-80. doi: 10.1055/s-0028-1090602. Epub 2008 Oct 16. No abstract available.
- Background: PubMed 7061556Gelberman RH, Nunley JA, Koman LA, Gould JS, Hergenroeder PT, MacClean CR, Urbaniak JR. The results of radial and ulnar arterial repair in the forearm. Experience in three medical centers. J Bone Joint Surg Am. 1982 Mar;64(3):383-7.
- Background: PubMed 3559079Nunley JA, Goldner RD, Koman LA, Gelberman R, Urbaniak JR. Arterial stump pressure: a determinant of arterial patency? J Hand Surg Am. 1987 Mar;12(2):245-9. doi: 10.1016/s0363-5023(87)80280-0.
- Background: PubMed 3994174Lee RE, Obeid FN, Horst HM, Bivins BA. Acute penetrating arterial injuries of the forearm. Ligation or repair? Am Surg. 1985 Jun;51(6):318-24.
- Background: PubMed 2606367Deutinger M, Porenta G, Metz V, Kaliman J, Freilinger G. [Hemodynamic and clinical studies following injury of the arteries of the forearm]. Handchir Mikrochir Plast Chir. 1989 Nov;21(6):283-6. German.
- Background: PubMed 7745646Aftabuddin M, Islam N, Jafar MA, Haque E, Alimuzzaman M. Management of isolated radial or ulnar arteries at the forearm. J Trauma. 1995 Jan;38(1):149-51. doi: 10.1097/00005373-199501000-00033.
- Background: PubMed 1495376Daoutis N, Gerostathopoulos N, Bouchlis G, Efstathopoulos D, Misitzis D, Anagnostou S, Vasiliadiw A. Results after repair of traumatic arterial damage in the forearm. Microsurgery. 1992;13(4):175-7. doi: 10.1002/micr.1920130405.
- Background: PubMed 8368933Johnson M, Ford M, Johansen K. Radial or ulnar artery laceration. Repair or ligate? Arch Surg. 1993 Sep;128(9):971-4; discussion 974-5. doi: 10.1001/archsurg.1993.01420210031004.
- Background: PubMed 9140949Ge XZ, Huang GK. Use of distal arteries for microvascular reconstruction in forearm and hand surgery. Microsurgery. 1996;17(4):180-3. doi: 10.1002/(SICI)1098-2752(1996)17:43.0.CO;2-P.
- Background: PubMed 5538419Hentschel M, Rucker G. [Treatment of arterial injuries of the forearm and hand]. Handchirurgie. 1970;2(1):18-21. No abstract available. German.
- Background: PubMed 2771822Stricker SJ, Burkhalter WE, Ouellette AE. Single-vessel forearm arterial repairs. Patency rates using nuclear angiography. Orthopedics. 1989 Jul;12(7):963-5. doi: 10.3928/0147-7447-19890701-08.
- Background: PubMed 501048Gelberman RH, Blasingame JP, Fronek A, Dimick MP. Forearm arterial injuries. J Hand Surg Am. 1979 Sep;4(5):401-8. doi: 10.1016/s0363-5023(79)80031-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander M. Spiess, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Extremity Arterial Surgery, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relationship of time after arterial repair with patency of the vessel (time frame: at least 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02228057, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2015.