About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Patients with tetraplegia due to a cervical spinal cord injury.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Cylinder test
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 outcomes
Grip ability as measured using the Grasp and Release Test (GRT)
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.
Grip strength will be measured with JAMAR dynamometer
Pinch grip strength will be assessed using the Pinch Gauge
Activity and participation (goal achievement and quality of life) will be measured using the Canadian Occupational Performance Measure (COPM)
Sponsors and contacts
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Göteborg University
Lead sponsor
Sahlgrenska University Hospital
Collaborator