Supporting Patient Decisions About UE Surgery in Cervical SCI



Status:Recruiting
Conditions:Hospital, Women's Studies
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:18 - 80
Updated:4/17/2018
Start Date:March 13, 2018
End Date:September 30, 2022
Contact:Carie Kennedy, BSN
Email:kennedyc@wustl.edu
Phone:314-362-4598

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Supporting Patient Decisions About Upper Extremity Surgery in Cervical Spinal Cord Injury (Aim 2)

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)

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.

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.
We found this trial at
4
sites
Palo Alto, California 94304
Phone: 650-725-7181
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Saint Louis, Missouri 63106
Principal Investigator: Katherine White Stenson, MD
Phone: 314-652-4100
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Ida K Fox, MD
Phone: 314-362-4598
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Phone: 650-725-7181
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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