NCT04276181 Combined Nerve and Tendon Transfer for the Restoration of Hand Function in Individuals With Tetraplegia
| NCT ID | NCT04276181 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Göteborg University |
| Condition | Spinal Cord Injury Cervical |
| Study Type | OBSERVATIONAL |
| Enrollment | 94 participants |
| Start Date | 2020-01-26 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 94 participants in total. It began in 2020-01-26 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04276181 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 55 Years, studying Spinal Cord Injury Cervical. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04276181 currently recruiting?
Yes, NCT04276181 is actively recruiting participants. Contact the research team at lina.bunketorp-kall@neuro.gu.se for enrollment information.
Where is the NCT04276181 trial being conducted?
This trial is being conducted at Mölndal, Sweden.
Who is sponsoring the NCT04276181 clinical trial?
NCT04276181 is sponsored by Göteborg University. The trial plans to enroll 94 participants.