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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-55
SponsorGöteborg University

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

94 Participants
are grouped into 2 trial groups
Group A: Combined Nerve and Tendon Transfer (CNaTT) group
Group B: Traditional transfer procedure group

Trial outcomes

Primary outcomes

1

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.

Time frame
5 minutes

Secondary outcomes

1

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.

Time frame
20 minutes
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

Other outcomes

Sponsors and contacts

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Göteborg University

Lead sponsor

Sahlgrenska University Hospital

Collaborator