Status:
RECRUITING
Combined Nerve and Tendon Transfer for the Restoration of Hand Function in Individuals With Tetraplegia
Lead Sponsor:
Göteborg University
Collaborating Sponsors:
Sahlgrenska University Hospital
Conditions:
Spinal Cord Injury Cervical
Tendon Transfer
Eligibility:
All Genders
15-55 years
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 d...
Detailed Description
Despite its incurability, surgical reconstruction of arm and hand function is a powerful tool to restore upper limb functions, as well as independence and control in individuals with tetraplegia. Pati...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04276181
Start Date
January 26 2020
End Date
December 31 2026
Last Update
August 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Advanced Reconstruction of Extremities, Sahlgrenska University Hospital/Mölndal
Mölndal, Sweden