Rehabilitation Clinical Trial
— [CNaTT]Official title:
Combined Nerve and Tendon Transfer for the Restoration of Hand Function in Individuals With Tetraplegia
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.
Status | Recruiting |
Enrollment | 94 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Center for Advanced Reconstruction of Extremities, Sahlgrenska University Hospital/Mölndal | Mölndal |
Lead Sponsor | Collaborator |
---|---|
Göteborg University | Sahlgrenska University Hospital, Sweden |
Sweden,
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Bertelli JA, Tacca CP, Ghizoni MF, Kechele PR, Santos MA. Transfer of supinator motor branches to the posterior interosseous nerve to reconstruct thumb and finger extension in tetraplegia: case report. J Hand Surg Am. 2010 Oct;35(10):1647-51. doi: 10.1016/j.jhsa.2010.07.012. — View Citation
Bossuyt FM, Arnet U, Brinkhof MWG, Eriks-Hoogland I, Lay V, Muller R, Sunnaker M, Hinrichs T; SwiSCI study group. Shoulder pain in the Swiss spinal cord injury community: prevalence and associated factors. Disabil Rehabil. 2018 Apr;40(7):798-805. doi: 10.1080/09638288.2016.1276974. Epub 2017 Jan 13. — View Citation
Bunketorp-Kall L, Wangdell J, Reinholdt C, Friden J. Satisfaction with upper limb reconstructive surgery in individuals with tetraplegia: the development and reliability of a Swedish self-reported satisfaction questionnaire. Spinal Cord. 2017 Jul;55(7):664-671. doi: 10.1038/sc.2017.12. Epub 2017 Feb 21. — View Citation
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. — View Citation
Friden J, Gohritz A. Tetraplegia Management Update. J Hand Surg Am. 2015 Dec;40(12):2489-500. doi: 10.1016/j.jhsa.2015.06.003. — View Citation
Friden J, Lieber RL. Reach out and grasp the opportunity: reconstructive hand surgery in tetraplegia. J Hand Surg Eur Vol. 2019 May;44(4):343-353. doi: 10.1177/1753193419827814. Epub 2019 Feb 11. — View Citation
Friden J, Reinholdt C, Turcsanyii I, Gohritz A. A single-stage operation for reconstruction of hand flexion, extension, and intrinsic function in tetraplegia: the alphabet procedure. Tech Hand Up Extrem Surg. 2011 Dec;15(4):230-5. doi: 10.1097/BTH.0b013e31821b5896. — View Citation
Moberg E. The present state of surgical rehabilitation of the upper limb in tetraplegia. Paraplegia. 1987 Aug;25(4):351-6. doi: 10.1038/sc.1987.63. No abstract available. — View Citation
O'Grady KM, Power HA, Olson JL, Morhart MJ, Harrop AR, Watt MJ, Chan KM. Comparing the Efficacy of Triple Nerve Transfers with Nerve Graft Reconstruction in Upper Trunk Obstetric Brachial Plexus Injury. Plast Reconstr Surg. 2017 Oct;140(4):747-756. doi: 10.1097/PRS.0000000000003668. — View Citation
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van Zyl N, Hahn JB, Cooper CA, Weymouth MD, Flood SJ, Galea MP. Upper limb reinnervation in C6 tetraplegia using a triple nerve transfer: case report. J Hand Surg Am. 2014 Sep;39(9):1779-83. doi: 10.1016/j.jhsa.2014.06.017. Epub 2014 Jul 23. — View Citation
Wangdell J, Bunketorp-Kall L, Koch-Borner S, Friden J. Early Active Rehabilitation After Grip Reconstructive Surgery in Tetraplegia. Arch Phys Med Rehabil. 2016 Jun;97(6 Suppl):S117-25. doi: 10.1016/j.apmr.2015.09.025. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 5 minutes | |
Secondary | 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. | 20 minutes | |
Secondary | Grip strength will be measured with JAMAR dynamometer | 2 minutes | ||
Secondary | Pinch grip strength will be assessed using the Pinch Gauge | 2 minutes | ||
Secondary | Activity and participation (goal achievement and quality of life) will be measured using the Canadian Occupational Performance Measure (COPM) | 10 minutes | ||
Secondary | Activity and participation will be measured using the Tetraplegic Upper Limb Activity Questionnaire (TUAQ). | Ranges between 13 to 130. Lower scores indicate a higher level of independence. | 10 minutes | |
Secondary | Satisfaction with surgery will be measured using the Swedish tetraplegia surgery satisfaction questionnaire. | Ranges between 20 - 100. Higher scores indicate a higher level of satisfaction | 10 minutes |
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