Supporting Patient Decisions About UE Surgery in Cervical SCI

NCT03464409 | Completed

• 1 other identifier: 201706092
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

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. 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. 2.Non-surgical control group: people with cervical SCI (N=20) and their caregiver (N=20)

Conditions

Cervical Spinal Cord Injury

Keywords

Nerve Transfer Surgery; Tendon Transfer Surgery; Decision Support Intervention

Outcome Measures

Primary Outcomes (1)

• Qualitative (interview) Analysis

  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 Outcomes (1)

• Quantitative (survey) Data Analysis

  24 months

Study Arms (3)

SCI Patient - Nerve Transfer Surgery

ACTIVE COMPARATOR

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; Other: Spinal Cord Independence Measure (SCIM-SR); Other: SF-36

SCI Patient - Tendon Transfer Surgery

ACTIVE COMPARATOR

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; Other: Spinal Cord Independence Measure (SCIM-SR); Other: SF-36

SCI Patient - No Surgery

ACTIVE COMPARATOR

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; Other: Spinal Cord Independence Measure (SCIM-SR); Other: SF-36

Interventions

Semi-structured interview OTHER

Semi-structured interviews to be conducted by a study team member.

SCI Patient - Nerve Transfer Surgery; SCI Patient - No Surgery; SCI Patient - Tendon Transfer Surgery

Spinal Cord Independence Measure (SCIM-SR) OTHER

The Spinal Cord Independence Measure - Self Report (SCIM-SR) is a self-report instrument for assessing functional independence of persons with spinal cord injury.

SCI Patient - Nerve Transfer Surgery; SCI Patient - No Surgery; SCI Patient - Tendon Transfer Surgery

SF-36 OTHER

A health-related quality of life (QoL) self-reported survey.

SCI Patient - Nerve Transfer Surgery; SCI Patient - No Surgery; SCI Patient - Tendon Transfer Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• At least 18 years of age
• Able to answer questions about the primary participant's experiences with cervical spinal cord injury
• The caregiver/spouse declines to participate in the study. Note: Caregiver participation is preferred, but not required, for SCI participant enrollment.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• United States Department of Defense: collaborator
• VA St. Louis Health Care System: collaborator
• VA Palo Alto Health Care System: collaborator
• Stanford University: collaborator

Study Sites (4)

Veterans Affairs Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Veterans Affairs St. Louis Health Care System

St Louis, Missouri, 63106, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (14)

• 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.

  PMID: 26397252 BACKGROUND

• 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.

  PMID: 25767422 BACKGROUND

• Curtin CM, Gater DR, Chung KC. Upper extremity reconstruction in the tetraplegic population, a national epidemiologic study. J Hand Surg Am. 2005 Jan;30(1):94-9. doi: 10.1016/j.jhsa.2004.10.007.

  PMID: 15680562 BACKGROUND

• Bertelli JA, Ghizoni MF, Tacca CP. Transfer of the teres minor motor branch for triceps reinnervation in tetraplegia. J Neurosurg. 2011 May;114(5):1457-60. doi: 10.3171/2010.12.JNS101519. Epub 2011 Jan 21.

  PMID: 21250798 BACKGROUND

• Bertelli JA, Ghizoni MF. Nerve transfers for elbow and finger extension reconstruction in midcervical spinal cord injuries. J Neurosurg. 2015 Jan;122(1):121-7. doi: 10.3171/2014.8.JNS14277.

  PMID: 25343189 BACKGROUND

• Bertelli JA, Tacca CP, Ghizoni MF, Kechele PR, Santos MA. Transfer of supinator motor branches to the posterior interosseous nerve to reconstruct thumb and finger extension in tetraplegia: case report. J Hand Surg Am. 2010 Oct;35(10):1647-51. doi: 10.1016/j.jhsa.2010.07.012.

  PMID: 20888500 BACKGROUND

• Friden J, Gohritz A. Brachialis-to-extensor carpi radialis longus selective nerve transfer to restore wrist extension in tetraplegia: case report. J Hand Surg Am. 2012 Aug;37(8):1606-8. doi: 10.1016/j.jhsa.2012.05.005. Epub 2012 Jun 30.

  PMID: 22749482 BACKGROUND

• Curtin CM, Hayward RA, Kim HM, Gater DR, Chung KC. Physician perceptions of upper extremity reconstruction for the person with tetraplegia. J Hand Surg Am. 2005 Jan;30(1):87-93. doi: 10.1016/j.jhsa.2004.08.014.

  PMID: 15680561 BACKGROUND

• Wagner JP, Curtin CM, Gater DR, Chung KC. Perceptions of people with tetraplegia regarding surgery to improve upper-extremity function. J Hand Surg Am. 2007 Apr;32(4):483-90. doi: 10.1016/j.jhsa.2007.01.015.

  PMID: 17398358 BACKGROUND

• 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.

  PMID: 25687516 BACKGROUND

• 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.

  PMID: 19030014 BACKGROUND

• 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.

  PMID: 27917237 BACKGROUND

• Joseph-Williams N, Newcombe R, Politi M, Durand MA, Sivell S, Stacey D, O'Connor A, Volk RJ, Edwards A, Bennett C, Pignone M, Thomson R, Elwyn G. Toward Minimum Standards for Certifying Patient Decision Aids: A Modified Delphi Consensus Process. Med Decis Making. 2014 Aug;34(6):699-710. doi: 10.1177/0272989X13501721. Epub 2013 Aug 20.

  PMID: 23963501 BACKGROUND

• Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.

  PMID: 24470076 BACKGROUND

Related Links

• Center for Nerve Injury \& Paralysis, Washington University in St. Louis School of Medicine

Study Officials

• Ida K Fox, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: March 13, 2018
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)