Supporting Patient Decisions About UE Surgery in Cervical SCI
NCT ID: NCT03464409
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2018-03-13
2021-08-30
Brief Summary
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1. Nerve or tendon transfer recipients: people who have elected to undergo nerve (N=10) or tendon (N=10) transfer surgery to restore some hand and arm function as part of their standard clinical care and their caregiver (N=20)
2. Non-surgical control group: people with cervical SCI (N=20) and their caregiver (N=20)
Detailed Description
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Understanding the pros and cons of any surgical intervention, especially in the setting of complex and often incomplete information, is challenging. Ultimately, this project will create a decision support intervention (DSI) that can be used to help clinicians and people living with cervical level SCI and their caregivers. It will be most useful to those with acute or sub-acute injury (\< 1year after SCI) for both military personnel and the general public. Clinicians and patients will have evidence to help them make decisions about treatments to improve upper extremity function.
In such a manner, patients can make more well-informed choices that are consistent with their values, needs and goals.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SCI Patient - Nerve Transfer Surgery
Patients aged 18 to 80 with a mid cervical level spinal cord injury seeking nerve transfer surgery to improve hand and arm function. Participants will be assessed at 3 time points: Baseline (pre-operatively), Early Followup (1 month post-operatively) and Late Followup (6-24 months later). Assessments will include the Spinal Cord Independence Measure (SCIM-SR), the 36-Item Short Form Health Survey (SF-36), and a semi-structured interview to be conducted by a study team member.
Semi-structured interview
Semi-structured interviews to be conducted by a study team member.
Spinal Cord Independence Measure (SCIM-SR)
The Spinal Cord Independence Measure - Self Report (SCIM-SR) is a self-report instrument for assessing functional independence of persons with spinal cord injury.
SF-36
A health-related quality of life (QoL) self-reported survey.
SCI Patient - Tendon Transfer Surgery
Patients aged 18 to 80 with a mid cervical level spinal cord injury seeking tendon transfer surgery to improve hand and arm function. Participants will be assessed at 3 time points: Baseline (pre-operatively), Early Followup (1 month post-operatively) and Late Followup (6-24 months later). Assessments will include the Spinal Cord Independence Measure (SCIM-SR), the 36-Item Short Form Health Survey (SF-36), and a semi-structured interview to be conducted by a study team member.
Semi-structured interview
Semi-structured interviews to be conducted by a study team member.
Spinal Cord Independence Measure (SCIM-SR)
The Spinal Cord Independence Measure - Self Report (SCIM-SR) is a self-report instrument for assessing functional independence of persons with spinal cord injury.
SF-36
A health-related quality of life (QoL) self-reported survey.
SCI Patient - No Surgery
Patients aged 18 to 80 with a mid cervical level spinal cord injury who did not chose to have surgery to improve hand and arm function. Participants will be assessed at 3 time points: Baseline, Early Followup (1 month later), and Late Followup (6-24 months later). Assessments will include the Spinal Cord Independence Measure (SCIM-SR), the 36-Item Short Form Health Survey (SF-36), and a semi-structured interview to be conducted by a study team member.
Semi-structured interview
Semi-structured interviews to be conducted by a study team member.
Spinal Cord Independence Measure (SCIM-SR)
The Spinal Cord Independence Measure - Self Report (SCIM-SR) is a self-report instrument for assessing functional independence of persons with spinal cord injury.
SF-36
A health-related quality of life (QoL) self-reported survey.
Interventions
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Semi-structured interview
Semi-structured interviews to be conducted by a study team member.
Spinal Cord Independence Measure (SCIM-SR)
The Spinal Cord Independence Measure - Self Report (SCIM-SR) is a self-report instrument for assessing functional independence of persons with spinal cord injury.
SF-36
A health-related quality of life (QoL) self-reported survey.
Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age
* Able to answer questions about the primary participant's experiences with cervical spinal cord injury
Exclusion Criteria
* Patient has ASIA D status (these patients may have progressive return of functionally useful motor function below the level of the SCI and would not routinely be offered acute surgical intervention and their experiences are less-relevant to the target patient population).
CAREGIVER PARTICIPANTS
* The caregiver/spouse declines to participate in the study. Note: Caregiver participation is preferred, but not required, for SCI participant enrollment.
18 Years
80 Years
ALL
No
Sponsors
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United States Department of Defense
FED
VA St. Louis Health Care System
FED
VA Palo Alto Health Care System
FED
Stanford University
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Ida K Fox, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Veterans Affairs Palo Alto Health Care System
Palo Alto, California, United States
Stanford University
Stanford, California, United States
Veterans Affairs St. Louis Health Care System
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Nerve Transfers to Restore Upper Extremity Function in Cervical Spinal Cord Injury: Update and Preliminary Outcomes. Plast Reconstr Surg. 2015 Oct;136(4):780-792. doi: 10.1097/PRS.0000000000001641.
Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Use of peripheral nerve transfers in tetraplegia: evaluation of feasibility and morbidity. Hand (N Y). 2015 Mar;10(1):60-7. doi: 10.1007/s11552-014-9677-z.
Curtin CM, Gater DR, Chung KC. Upper extremity reconstruction in the tetraplegic population, a national epidemiologic study. J Hand Surg Am. 2005 Jan;30(1):94-9. doi: 10.1016/j.jhsa.2004.10.007.
Bertelli JA, Ghizoni MF, Tacca CP. Transfer of the teres minor motor branch for triceps reinnervation in tetraplegia. J Neurosurg. 2011 May;114(5):1457-60. doi: 10.3171/2010.12.JNS101519. Epub 2011 Jan 21.
Bertelli JA, Ghizoni MF. Nerve transfers for elbow and finger extension reconstruction in midcervical spinal cord injuries. J Neurosurg. 2015 Jan;122(1):121-7. doi: 10.3171/2014.8.JNS14277.
Bertelli JA, Tacca CP, Ghizoni MF, Kechele PR, Santos MA. Transfer of supinator motor branches to the posterior interosseous nerve to reconstruct thumb and finger extension in tetraplegia: case report. J Hand Surg Am. 2010 Oct;35(10):1647-51. doi: 10.1016/j.jhsa.2010.07.012.
Friden J, Gohritz A. Brachialis-to-extensor carpi radialis longus selective nerve transfer to restore wrist extension in tetraplegia: case report. J Hand Surg Am. 2012 Aug;37(8):1606-8. doi: 10.1016/j.jhsa.2012.05.005. Epub 2012 Jun 30.
Curtin CM, Hayward RA, Kim HM, Gater DR, Chung KC. Physician perceptions of upper extremity reconstruction for the person with tetraplegia. J Hand Surg Am. 2005 Jan;30(1):87-93. doi: 10.1016/j.jhsa.2004.08.014.
Wagner JP, Curtin CM, Gater DR, Chung KC. Perceptions of people with tetraplegia regarding surgery to improve upper-extremity function. J Hand Surg Am. 2007 Apr;32(4):483-90. doi: 10.1016/j.jhsa.2007.01.015.
Fox PM, Suarez P, Hentz VR, Curtin CM. Access to surgical upper extremity care for people with tetraplegia: an international perspective. Spinal Cord. 2015 Apr;53(4):302-5. doi: 10.1038/sc.2015.3. Epub 2015 Feb 17.
Anderson KD, Friden J, Lieber RL. Acceptable benefits and risks associated with surgically improving arm function in individuals living with cervical spinal cord injury. Spinal Cord. 2009 Apr;47(4):334-8. doi: 10.1038/sc.2008.148. Epub 2008 Nov 25.
Cain SA, Gohritz A, Friden J, van Zyl N. Review of Upper Extremity Nerve Transfer in Cervical Spinal Cord Injury. J Brachial Plex Peripher Nerve Inj. 2015 Aug 6;10(1):e34-e42. doi: 10.1055/s-0035-1558427. eCollection 2015 Dec.
Joseph-Williams N, Newcombe R, Politi M, Durand MA, Sivell S, Stacey D, O'Connor A, Volk RJ, Edwards A, Bennett C, Pignone M, Thomson R, Elwyn G. Toward Minimum Standards for Certifying Patient Decision Aids: A Modified Delphi Consensus Process. Med Decis Making. 2014 Aug;34(6):699-710. doi: 10.1177/0272989X13501721. Epub 2013 Aug 20.
Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
Related Links
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Center for Nerve Injury \& Paralysis, Washington University in St. Louis School of Medicine
Other Identifiers
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201706092
Identifier Type: -
Identifier Source: org_study_id