Restoring hand function in individuals with tetraplegia using nerve and tendon transfer techniques
Combined Nerve and Tendon Transfer for the Restoration of Hand Function in Individuals With Tetraplegia
Göteborg University · NCT04276181
This study is testing new surgeries that combine nerve and tendon transfers to help people with tetraplegia improve their hand function and gain more independence.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 94 (estimated) |
| Ages | 15 Years to 55 Years |
| Sex | All |
| Sponsor | Göteborg University (other) |
| Locations | 1 site (Mölndal) |
| Trial ID | NCT04276181 on ClinicalTrials.gov |
What this trial studies
This study focuses on improving hand function in individuals with tetraplegia resulting from cervical spinal cord injuries. It explores the combined use of nerve and tendon transfer surgeries to enhance grip strength and hand opening capabilities. The approach aims to provide patients with greater independence and control over their upper limbs by utilizing advanced surgical techniques. The study is conducted at the Centre for Advanced Reconstruction of Extremities, where experienced surgeons refine these surgical strategies to maximize patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 15-55 with a spinal cord injury at AIS levels C5 to C7, who are within 12 months post-injury.
Not a fit: Patients with severe finger extensor weakness or other serious medical conditions that could complicate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance hand function and independence for patients with tetraplegia.
How similar studies have performed: While nerve transfer techniques have shown success in brachial plexus injuries, their application in tetraplegia is less common, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mölndal
- Center for Advanced Reconstruction of Extremities, Sahlgrenska University Hospital/Mölndal — Mölndal, Sweden (RECRUITING)
Study contacts
- Study coordinator: Lina Bunketorp-Käll, PhD
- Email: lina.bunketorp-kall@neuro.gu.se
- Phone: +46709723101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injury Cervical, Tendon Transfer, Nerve Transfer, Rehabilitation, Grip Function