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Search / Trial NCT04276181

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

Launched by GÖTEBORG UNIVERSITY · Feb 18, 2020

Trial Information

Current as of July 04, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new surgical approach to help improve hand function in people who have tetraplegia, which is paralysis affecting all four limbs due to a spinal cord injury. The researchers at the Centre for Advanced Reconstruction of Extremities are testing a combined surgery that uses both nerve and tendon transfers. This method aims to allow patients not only to grip objects better but also to actively open their hands, which is an important part of everyday tasks. They want to see if this combined approach works better than traditional surgery that only focuses on grip function.

To participate in the trial, individuals must be between 15 and 55 years old and have a spinal cord injury at specific levels (C5 to C7) that occurred within the last 12 months. Participants should have a certain level of muscle strength to ensure the surgery can be effective. If you join the study, you can expect to undergo the combined surgery and be part of assessments to see how well your hand function improves. This trial is crucial because it aims to fill a gap in knowledge about how effective this new combined method is compared to the existing treatments.

Gender

ALL

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

About Göteborg University

Göteborg University, a leading academic institution in Sweden, is committed to advancing healthcare through innovative research and clinical trials. With a strong focus on interdisciplinary collaboration, the university leverages its extensive expertise in various fields, including medicine, pharmacology, and social sciences, to address pressing health challenges. By sponsoring clinical trials, Göteborg University aims to contribute to the development of new therapies and improve patient outcomes, while adhering to the highest ethical standards and regulatory requirements. Their dedication to rigorous scientific inquiry and community engagement positions them as a pivotal player in the global health research landscape.

Locations

Mölndal, , Sweden

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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