NCT01714349

Brief Summary

Nerve Transfer surgery can provide improved hand function following cervical spinal cord injuries

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

10.5 years

First QC Date

October 22, 2012

Last Update Submit

March 21, 2023

Conditions

Spinal Cord Injury

Keywords

Spinal cord injurynerve transfertetraplegiaquadriplegia

Outcome Measures

Primary Outcomes (1)

  • Change in upper motor strength

    Patients motor strength will be assessed over 48 months of clinical follow-up with conventional manual motor testing

    48 months

Secondary Outcomes (3)

  • Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores

    48 months

  • Change in Short Form 36 (SF-36) scores

    48 months

  • Change in Michigan Hand Questionnaire (MHQ)

    48 months

Other Outcomes (4)

  • Rates of Intraoperative and Post-operative complications

    48 months

  • Effect of timing on surgical intervention

    48 months

  • Rate of reoperation

    48 months

  • +1 more other outcomes

Study Arms (1)

Nerve Transfer

EXPERIMENTAL

Surgical - Nerve transfers for patients with stable cervical spinal cord injuries

Procedure: Nerve Transfer

Interventions

Nerve TransferPROCEDURE

A nerve transfer procedure will be individualized to each patient's functional deficit.

Nerve Transfer

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Informed Consent Document (ICD) signed by patient
  • Cervical spinal cord injury resulting in arm \& hand functional impairment, with at least preserved elbow function
  • International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0 - 4
  • Patients with a stable American Spinal Injury Association (ASIA) grade of A, B, or C, or with a diagnosis of central cord syndrome, showing minimal to no evidence of functional improvement in motor examination after at least 6 months of non-operative therapy post-injury
  • Appropriate candidate for nerve transfer study
  • Willing and able to comply with the study protocol
  • \< 48 months from injury

You may not qualify if:

  • Active infection at the operative site or systemic infection
  • Any return or ongoing clinical recovery of distal motor function within 6 months after injury
  • Physically or mentally compromised
  • Currently undergoing long-term steroid therapy
  • Significant joint contractures and/or limitations in passive range of motion in the arm or hand
  • Active malignancy
  • Systemic disease that would affect the patient's welfare or the research study
  • Pregnant
  • Immunologically suppressed or immunocompromised
  • Significant pain or hypersensitivity
  • Previous or current injury preventing use of tendon transfers to restore upper extremity function
  • Affective disorder of a degree that would make outcome assessment and study participation difficult
  • History of brachial plexus injury or systemic neuropathic process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesQuadriplegia

Interventions

Nerve Transfer

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Wilson Z Ray, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2012

First Posted

October 25, 2012

Study Start

October 1, 2012

Primary Completion

March 20, 2023

Study Completion

March 20, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

US(1)