Actively Recruiting

Age: 15Years - 55Years
All Genders
ID04276181

Combined Nerve and Tendon Transfer for Restoring Hand Function in People With Tetraplegia After Cervical Spinal Cord Injury

Led by Göteborg University · Updated on 2024-08-09

94

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

G

Göteborg University

Lead Sponsor

S

Sahlgrenska University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research focuses on individuals with tetraplegia caused by cervical spinal cord injury, which severely limits their ability to use their hands and perform daily activities. It aims to compare two surgical approaches to restore hand function: a combined nerve and tendon transfer procedure (CNaTT) and the traditional tendon transfer surgery alone. The study addresses a significant gap by evaluating whether the combined approach, which may improve hand opening and grip function, offers better clinical outcomes than the traditional method. The combined procedure involves first performing a nerve transfer called Bertelli S-PIN, which aims to restore active opening of the hand by rerouting nerves to paralyzed muscles. This is followed by tendon transfer surgeries to restore strong finger and thumb flexion for grip. The traditional approach uses tendon transfers alone to restore grip without active hand opening. Both procedures involve specific surgical techniques and rehabilitation protocols, including immobilization and training phases to enhance muscle strength and function. Participants will be assessed through various tests, including the Cylinder test to measure hand function and grip strength assessments using devices like the JAMAR dynamometer and Pinch Gauge. Quality of life and satisfaction with surgery will also be evaluated using validated questionnaires. The study includes patients aged 15 to 55 with recent cervical spinal cord injuries and will monitor outcomes one year after surgery to determine the effectiveness of the procedures in improving hand function and independence.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 15Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 15 and 55 years
  • Diagnosed with spinal cord injury at AIS level C5 to C7
  • Time since injury is 12 months or less
  • Supinator muscle strength graded 4 or higher on Medical Research Council scale
  • Strength of brachioradialis and wrist extensors graded 4 or higher on Medical Research Council scale
Not Eligible

You will not qualify if you...

  • Finger extensor strength graded 1 or lower on Medical Research Council scale
  • Evidence of lower motor neuron injury in muscles supplied by the donor nerve
  • Having any serious or unstable illness that could interfere with the study
  • Medically unstable for surgery as determined by a physician
  • Forearm or hand spasticity graded higher than 1 on Modified Ashworth Scale

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo either combined nerve and tendon transfer surgery or traditional tendon transfer surgery to restore hand function after cervical spinal cord injury.

1 surgical visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 2 weeks

Participants have a short immobilization period of about 2 weeks in a hinged orthosis restricting full extension of the elbow after surgery.

Regular post-surgical visits during immobilization period

Post-operative Follow-up

Duration - Up to 12 months after surgery

Participants gradually begin movement and training without restrictions, including activation of donor nerve movements and rehabilitation to strengthen muscles. Follow-up assessments include tests of grip strength, hand function, and satisfaction with surgery.

Multiple follow-up visits over 12 months

Trial Site Locations

Total: 1 location

1

Center for Advanced Reconstruction of Extremities, Sahlgrenska University Hospital/Mölndal

Mölndal, Sweden

Actively Recruiting

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Research Team

L

Lina Bunketorp-Käll, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Satisfaction with upper limb reconstructive surgery in individuals with tetraplegia: the development and reliability of a Swedish self-reported satisfaction questionnaire.

L Bunketorp-Käll, J Wangdell, C Reinholdt...

https://pubmed.ncbi.nlm.nih.gov/28220821

Survey of the needs of patients with spinal cord injury: impact and priority for improvement in hand function in tetraplegics.

G J Snoek, M J IJzerman, H J Hermens...

https://pubmed.ncbi.nlm.nih.gov/15224087

Comparing the Efficacy of Triple Nerve Transfers with Nerve Graft Reconstruction in Upper Trunk Obstetric Brachial Plexus Injury.

Kathleen M O'Grady, Hollie A Power, Jaret L Olson...

https://pubmed.ncbi.nlm.nih.gov/28609352