Upper Extremity Surgery in Spinal Cord Injury

NCT01899664 | Completed

• 1 other identifier: 201205104
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the investigators work is to establish how nerve transfers can be best used to improve upper extremity function in patients with cervical level spinal cord injury (SCI). The investigators' hypothesis is that nerve transfers are safe and effective and will improve function and quality of life in patients with loss of upper function due to spinal cord injury. The investigators plan on looking at upper limb function, and health-related quality of life in patients before and after surgery to better understand how patients benefit from these treatments. A nerve transfer procedure can be used to rewire the system to make some muscles work again following SCI. The nerve transfer procedure (which is done in the arm and not at the level of the spinal cord) can be used to bypass the damaged area and to deliver a signal from the brain to a muscle that became disconnected following that injury. A donor nerve is taken from another muscle whose use is not essential and then transferred to help in providing more a more critical function. For example, one type of nerve transfer is done to restore the lost ability to pinch or grasp small objects between the fingers that occurs in many patients with cervical SCI. In this surgery, a donor nerve that normally helps flex the elbow. This nerve can be used because the biceps muscle is also working to flex the elbow. This donor nerve is cut and re-attached to the nerve going to muscles in the forearm that provide pinch by bending the tips of the thumb and index finger. Because the nerve transfer procedure involves cutting and reattaching nerve and muscle tissues, time is required to regenerate working connections between the nerves and muscle as well as to allow the brain to relearn how to use and strengthen that muscle.

Conditions

Quadriplegia; Spinal Cord Diseases; Spinal Cord Injuries

Keywords

peripheral nerves; quadriplegia; nerve transfer; surgical procedures, operative; hand; upper extremity; quality of life

Outcome Measures

Primary Outcomes (1)

• Upper extremity function.

  Upper extremity function as measured by manual muscle testing and range of motion as well as the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) test (this is a standardized functional test to assess upper extremity function in patients with spinal cord injury) and International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) test (this is an examination used to determine the motor and sensory impairment and severity of a spinal cord injury).

  change from baseline at 6, 12, 24, 30 and 36 months post-surgery

Secondary Outcomes (1)

• Health related quality of life.

  change from baseline at 6, 12, 24, 30 and 36 months post-surgery

Study Arms (1)

Primary Study Population

OTHER

Study participants (primary study population) will include patients with spinal cord injury at the mid cervical level who are undergoing evaluation for possible surgical treatment with nerve transfers and or tendon transfer/tenodesis to improve their upper extremity function. All enrolled participants will receive the same standard of care surgical procedures.

Procedure: Nerve Transfer Surgery

Interventions

Nerve Transfer Surgery PROCEDURE

Unilateral surgery will be performed under general non-paralytic anesthesia and no-tourniquet conditions to allow for responsive nerve simulation.

Primary Study Population

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• clinical diagnosis of cervical level spinal cord injury
• some upper extremity dysfunction (ex: lack of wrist extension or hand function)
• greater then 6 months post-injury or with stable neurologic function for at least 6 months post-injury
• good access to and ability to pay for hand and physical therapy
• ability to comply and participate in rigorous post-surgical therapy regimen

You may not qualify if:

• severe autonomic dysreflexia
• open pressure sores or other wounds
• respiratory insufficiency
• untreated urinary tract infections
• lack of access to physical therapy

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University Division of Plastic Surgery

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

• 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 RESULT

• 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 RESULT

• Hill EJR, Fox IK. Current Best Peripheral Nerve Transfers for Spinal Cord Injury. Plast Reconstr Surg. 2019 Jan;143(1):184e-198e. doi: 10.1097/PRS.0000000000005173.

  PMID: 30589809 DERIVED

Related Links

• Patient information and intake forms.

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Diseases; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ida K. Fox, 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

Model Details: Subjects will undergo the following: A full International Standards for Neurological Classification of SCI exam will be completed to determine exact function and type of spinal cord injury. A phone interview will be completed at both preoperative and postoperative time points. Quality of life before and after surgical intervention will be derived from standardized questionnaires: Spinal Cord Independence Measure (SCIM), SF-36, Novak scale, and pain questionnaires. Additional qualitative and quantitative data on donor and recipient nerve function and tissue will be derived from preoperative electrodiagnostic studies. Specimens of the donor and recipient nerve are collected for histologic analysis during the operative procedure. Those trimmed nerve specimens are then analyzed for clinical purposes to give patients an idea of expected outcome in a more timely fashion.

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 15, 2013
• Study Start: June 1, 2012
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)