Actively Recruiting

Age: 15Years - 55Years
All Genders
NCT04276181

Combined Nerve and Tendon Transfer for the Restoration of Hand Function in Individuals With Tetraplegia

Led by Göteborg University · Updated on 2024-08-09

94

Participants Needed

1

Research Sites

361 weeks

Total Duration

On this page

Sponsors

G

Göteborg University

Lead Sponsor

S

Sahlgrenska University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Combined Nerve and Tendon Transfer for the Restoration of Hand Function in Individuals With Tetraplegia

Who Can Participate

Age: 15Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 C 12 months
  • The strength of the muscle supplied by the donor nerve (supinator) must be graded E 4 according to Medical Research Council (MRC)
  • The strength of musculus brachioradialis and wrist extensors must be graded E 4 according to MRC (to be used in grip reconstruction)
Not Eligible

You will not qualify if you...

  • Finger extensor strength C 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 E 1 according to Modified Ashworth Scale

AI-Screening

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Trial Site Locations

Total: 1 location

1

Center for Advanced Reconstruction of Extremities, Sahlgrenska University Hospital/Mölndal

Mölndal, Sweden

Actively Recruiting

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Research Team

L

Lina Bunketorp-Käll, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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