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Combined Nerve and Tendon Transfer for the Restoration of Hand Function in Individuals With Tetraplegia ([CNaTT])

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ClinicalTrials.gov Identifier: NCT04276181
Recruitment Status : Not yet recruiting
First Posted : February 19, 2020
Last Update Posted : August 5, 2020
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Lina Bunketorp Kall, Göteborg University

Brief Summary:
Tetraplegia after a cervical spinal cord injury (C-SCI) radically alters an individual's ability to perform normal activities of daily life due to paralysis in all extremities, resulting in lifelong dependence.[1] Traditional tendon transfer surgery has proven successful in restoring grip functions which greatly improves autonomy, but with a restricted passive opening of the hand. The number of transferrable muscles in the arm is however limited, why nerve transfer surgery is a new attractive option to further improve hand function by enabling active opening of the hand. Significant advantages of distal nerve transfers include less extensive surgical dissection, greatly reduced hospital stay, rehabilitation and restrictions, and thereby less health care use and costs. In an effort to further improve hand function and independence in patients with tetraplegia, hand surgeons at Centre for Advanced Reconstruction of Extremities (C.A.R.E.), Sahlgrenska University Hospital (SUH)/Mölndal have developed a strategy in which a nerve transfer procedure aiming to restore active opening of the hand is done prior to reconstruction of grip functions. To date, no study has compared the efficacy of this combined nerve and tendon transfer (CNaTT) procedure to traditional grip reconstruction by means of tendon transfer alone, thus constituting a major gap in the literature. The purpose of this study is therefore to fill that knowledge gap by comparing the clinical outcomes of a cohort of patients who undergo the CNaTT procedure to restore hand function, to those treated by means of tendon transfer alone.

Condition or disease
Spinal Cord Injury Cervical Tendon Transfer Nerve Transfer Rehabilitation Grip Function

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Combined Nerve and Tendon Transfer for the Restoration of Hand Function in Individuals With Tetraplegia
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Group/Cohort
CNaTT
The surgical procedures are described in the section Detailed description



Primary Outcome Measures :
  1. Cylinder test [ Time Frame: 5 minutes ]
    This test is developed at SUH and currently under reliability testing. The cylinder test assesses the patients' ability to actively grasp and release glass cylinders of varying breadth, ranging from 10 to 150 mm.


Secondary Outcome Measures :
  1. Grip ability as measured using the Grasp and Release Test (GRT) [ Time Frame: 20 minutes ]
    GRT assesses the ability to pick up, move, and release six objects of varying sizes, weights and textures using a palmar or lateral grasp. Each object represents one or more objects routinely manipulated for activities of daily living (ADL) that represented a range of difficulties.

  2. Grip strength will be measured with JAMAR dynamometer [ Time Frame: 2 minutes ]
  3. Pinch grip strength will be assessed using the Pinch Gauge [ Time Frame: 2 minutes ]
  4. Activity and participation (goal achievement and quality of life) will be measured using the Canadian Occupational Performance Measure (COPM) [ Time Frame: 10 minutes ]
  5. Activity and participation will be measured using the Tetraplegic Upper Limb Activity Questionnaire (TUAQ). [ Time Frame: 10 minutes ]
    Ranges between 13 to 130. Lower scores indicate a higher level of independence.

  6. Satisfaction with surgery will be measured using the Swedish tetraplegia surgery satisfaction questionnaire. [ Time Frame: 10 minutes ]
    Ranges between 20 - 100. Higher scores indicate a higher level of satisfaction



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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with tetraplegia due to a cervical spinal cord injury.
Criteria

Inclusion criteria:

  • Subjects must be between 15-55 years of age
  • Subjects must be diagnosed with a spinal cord injury AIS level C5 to C7
  • Time after injury ≤ 12 months
  • The strength of the muscle supplied by the donor nerve (supinator) must be graded ≥ 4 according to Medical Research Council (MRC)
  • The strength of musculus brachioradialis and wrist extensors must be graded ≥ 4 according to MRC (to be used in grip reconstruction)

Exclusion criteria:

  • Finger extensor strength ≤ MRC 1
  • Evidence of lower motor neuron injury in muscles supplied by the donor nerve
  • Subjects must not have any current serious or unstable illness that could interfere with the study
  • Medically unstable to undergo surgery as determined by physician
  • Spasticity in the forearm or hand graded > 1 according to Modified Ashworth Scale

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276181


Contacts
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Contact: Lina Bunketorp-Käll, PhD +46709723101 ext +46709723101 lina.bunketorp-kall@neuro.gu.se

Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
Publications:

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Responsible Party: Lina Bunketorp Kall, Principal Investigator, Göteborg University
ClinicalTrials.gov Identifier: NCT04276181    
Other Study ID Numbers: ALFGBG-918031
ALFGBG-774951 ( Other Grant/Funding Number: the Swedish state under the agreement between the Swedish government and the county councils, the ALF agreement )
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations