Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Sweden / NCT04276181
Recruiting Observational

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

NCT04276181 · tracked via the Priya Life Science Sweden tracker
Sponsor
Göteborg University
Phase
Observational
Started
2020-01-26
Last updated
2024-08-09

Condition(s) studied

Spinal Cord Injury CervicalTendon TransferNerve TransferRehabilitationGrip Function

Study 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

Sex
ALL
Min age
15 Years
Max age
55 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Cylinder test — 5 minutes
    This test is developed at SUH and currently under reliability testing. The cylinder test assesses the patients' ability to actively grasp and release glass cylinders of varying breadth, ranging from 10 to 150 mm.

Trial sites (1)

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

More Göteborg University trials in Sweden

SALpingectomy for STERilization (SALSTER) Active, not recruiting
Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction Active, not recruiting
The Effects of Nitrate-Rich Mouthwash on Vascular Tone Starting soon
Sahlgrenska Cardiomyopathy Project Enrolling by invitation
Effects of and Exploring the Processes of Free Movement Dance as a Physical Therapy Intervention for Female Patients Diagnosed With Chronic Widespread Pain (Including Fibromyalgia). Active, not recruiting

Other trials for the same condition

Evaluation of the Wheelchair School (Drivkraft) a Clinical Study Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04276181 on ClinicalTrials.gov ↗ ← All trials in Sweden