Status:
COMPLETED
Supporting Patient Decisions About UE Surgery in Cervical SCI
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
United States Department of Defense
VA St. Louis Health Care System
Conditions:
Cervical Spinal Cord Injury
Eligibility:
All Genders
18-80 years
Phase:
NA
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 s...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2021
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03464409
Start Date
March 13 2018
End Date
August 30 2021
Last Update
November 3 2021
Active Locations (4)
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1
Veterans Affairs Palo Alto Health Care System
Palo Alto, California, United States, 94304
2
Stanford University
Stanford, California, United States, 94305
3
Veterans Affairs St. Louis Health Care System
St Louis, Missouri, United States, 63106
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110