Supporting Patient Decisions About UE Surgery in Cervical SCI

Trial ID or NCT#

NCT03464409

Status

not recruiting iconNOT RECRUITING

Purpose

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)

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 to 80
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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).
    1. Exclusion criteria:
  2. * 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).
    1. CAREGIVER PARTICIPANTS
    2. Inclusion criteria:
  3. * At least 18 years of age* Able to answer questions about the primary participant's experiences with cervical spinal cord injury
    1. Exclusion criteria:
  4. * The caregiver/spouse declines to participate in the study. Note: Caregiver participation is preferred, but not required, for SCI participant enrollment.
Exclusion Criteria:
  1. * 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).
    1. CAREGIVER PARTICIPANTS
    2. Inclusion criteria:
  2. * At least 18 years of age* Able to answer questions about the primary participant's experiences with cervical spinal cord injury
    1. Exclusion criteria:
  3. * The caregiver/spouse declines to participate in the study. Note: Caregiver participation is preferred, but not required, for SCI participant enrollment.
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Investigator(s)

Catherine Curtin MD
Catherine Curtin MD
Hand and upper extremity surgeon
Professor of Surgery (Plastic & Reconstructive Surgery) and, by courtesy, of Orthopaedic Surgery

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Contact

Catherine Curtin, MD
650-725-7181

View on ClinicalTrials.gov