Supporting Patient Decisions About UE Surgery in Cervical SCI

November 1, 2021 updated by: Washington University School of Medicine

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Veterans Affairs Palo Alto Health Care System
      • Stanford, California, United States, 94305
        • Stanford University
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63106
        • Veterans Affairs St. Louis Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: Semi-structured interview
Semi-structured interviews to be conducted by a study team member.
Other: 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.
Other: SF-36
A health-related quality of life (QoL) self-reported survey.
Active Comparator: 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.
Other: Semi-structured interview
Semi-structured interviews to be conducted by a study team member.
Other: 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.
Other: SF-36
A health-related quality of life (QoL) self-reported survey.
Active Comparator: 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.
Other: Semi-structured interview
Semi-structured interviews to be conducted by a study team member.
Other: 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.
Other: SF-36
A health-related quality of life (QoL) self-reported survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative (interview) Analysis
Time Frame: 24 months
All interviews will be transcribed verbatim and analyzed using standard qualitative text analysis. Members of the research team will read the transcripts for accuracy and to determine potential topics for coding. The investigators will develop a codebook using inductive and deductive codes. Deductive codes will be directly linked to our research questions. Adding inductive codes, where topics and codes are not pre-determined but are derived directly from the data, will allow the research team to develop a sense of how patients experience the surgical process, and allows for unexpected findings to emerge. Once the codebook is determined, two members of the research team will code the transcripts. Codes will be compared between raters. The investigators will use the codes to infer themes in the data.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative (survey) Data Analysis
Time Frame: 24 months
The data analysis will be conducted within each group. To account for correlations among repeated measures from the same patient, the longitudinal data will be analyzed using a mixed model to examine the change in survey outcomes.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

United States Department of Defense
Stanford University
VA Palo Alto Health Care System
VA St. Louis Health Care System

Investigators

  • Principal Investigator: Ida K Fox, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2018

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 7, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201706092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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