Clinical trial NCT03464409: Supporting Patient Decisions About UE Surgery in Cervical SCI
Official title: Supporting Patient Decisions About Upper Extremity Surgery in Cervical Spinal Cord Injury (Aim 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Spinal Cord Injury
Keywords: Nerve Transfer Surgery
Tendon Transfer Surgery
Decision Support Intervention
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: VA St. Louis Health Care System
name: VA Palo Alto Health Care System
name: Stanford University
First posted: 2018-03-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to collect and describe patient and caregiver reported outcomes regarding surgical and non-surgical treatment for improving hand and arm function in the setting of cervical spinal cord injury. Eligible study participants will be recruited across the 4 sites and the investigators plan to recruit the following groups and numbers of participants:

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: At present, there is limited information that provides the exact time course and probability of gain in specific function (such as hand function) that might help patients and clinicians make decisions regarding novel and time-sensitive surgical treatment options.

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.

Eligibility criteria: CERVICAL SPINAL CORD INJURY PARTICIPANTS

Inclusion criteria:

* Adult subjects (≥18 years and \< 80 years) with cervical level SCI ASIA A, B or C (minimum 6 months and maximum 20 years post-injury).

Exclusion criteria:

* Patient who chooses simultaneous tendon and nerve transfer procedure (this would preclude separation of the influence of one surgery compared to the other)
* 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

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:

* The caregiver/spouse declines to participate in the study. Note: Caregiver participation is preferred, but not required, for SCI participant enrollment.

Primary outcomes:
measure: Qualitative (interview) Analysis
timeFrame: 24 months
Secondary outcomes:
measure: Quantitative (survey) Data Analysis
timeFrame: 24 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Veterans Affairs Palo Alto Health Care System
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Saint Louis
country: United States
facility: Veterans Affairs St. Louis Health Care System
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ida K Fox, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
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