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Trial registered on ANZCTR


Registration number
ACTRN12615000179538
Ethics application status
Approved
Date submitted
7/08/2014
Date registered
24/02/2015
Date last updated
19/08/2019
Date data sharing statement initially provided
19/08/2019
Date results information initially provided
19/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nerve transfer surgery in the upper limb of patients with tetraplegia
Scientific title
The effect of nerve transfer surgery on upper limb function in patients with tetraplegia after traumatic spinal cord injury
Secondary ID [1] 285121 0
None
Universal Trial Number (UTN)
U1111-1160-1375
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 292680 0
Condition category
Condition code
Neurological 292995 292995 0 0
Other neurological disorders
Injuries and Accidents 293235 293235 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nerve transfer surgery involves the transfer of an expendable, intact nerve (or fascicle of a nerve) to the non-functional nerve of a paralysed muscle. Nerves are carefully identified and dissected to prepare for the transfer. The donor and recipient nerves are divided in close proximity and are then co-apted or joined with the use of an operating microscope. The duration of surgery varies depending on the nerves involved but can range from 1-2 hours per transfer. Post operatively, the arm is immobilised for 2-3 weeks to protect the transfer.

After the period of immobilisation, rehabilitation is provided by an occupational therapist. Between 3 weeks to 6 months, depending on target nerve, daily pairing exercises (pairing donor muscle action to recipient muscle action) are performed till the first flickers of activity in recipient muscle/s are observed. Pairing continues till muscle strength is M3 or stable for 3 months, then dissociation between donor and recipient actions is encouraged. A home exercise program will be completed 2 – 5 times a day, initially for pairing exercises then active strengthening, totalling no more than 15 minutes each day.
Intervention code [1] 289972 0
Treatment: Surgery
Intervention code [2] 289973 0
Rehabilitation
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292857 0
Change in score on Action Research Arm Test
Timepoint [1] 292857 0
24 months post-operatively
Primary outcome [2] 292858 0
Change in score on the Grasp-Release Test
Timepoint [2] 292858 0
24 months post-operatively
Primary outcome [3] 292859 0
Change in score on the Spinal Cord Independence Measure
Timepoint [3] 292859 0
24 months post-operatively
Secondary outcome [1] 309814 0
Histological description of nerve tissue samples
Timepoint [1] 309814 0
At time of surgery
Secondary outcome [2] 309815 0
Neurophysiological assessments including nerve conduction studies of donor nerves and needle electromyography of donor muscles.
Timepoint [2] 309815 0
At time of surgery
Secondary outcome [3] 309816 0
Cost-benefit analysis using the Health Utilities Index Mark 3
Timepoint [3] 309816 0
24 months post-operatively

Eligibility
Key inclusion criteria
1. Complete or incomplete tetraplegia with C5 – C7 motor neurological level
2. Spinal injury sustained within the last 12-18 months
3. Assessed as suitable for nerve transfer surgery by the surgical and occupational therapy team at the Upper
Limb Program Multidisciplinary Clinic at Royal Talbot.
4. Consent to nerve transfer surgery after being fully informed about expected outcomes, potential risks, surgical
procedure, recovery time, postoperative therapy commitments and the same for the equivalent tendon transfers
5. Able to comply with therapy protocols postoperatively
Minimum age
12 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Accompanying head injury, brachial plexus or peripheral nerve injury at the time of, or preceding the spinal cord
injury
2. Any other pre-existing neurological condition
3. Cognitive impairment limiting ability to consent to surgery or comply with postoperative rehabilitation
4. Skeletal or joint injury significantly limiting passive range of movement across a joint relevant to the proposed
nerve transfer

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2821 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 8508 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 289733 0
Charities/Societies/Foundations
Name [1] 289733 0
Institute for Safety Compensation and Recovery Research
Address [1] 289733 0
Level 11, 499 St Kilda Road
Melbourne, VIC 3004
Country [1] 289733 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville, VIC 3010
Country
Australia
Secondary sponsor category [1] 288426 0
None
Name [1] 288426 0
Address [1] 288426 0
Country [1] 288426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291468 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 291468 0
Office for Research
Level 8, Harold Strokes Building
Austin Health
145 Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 291468 0
Australia
Date submitted for ethics approval [1] 291468 0
Approval date [1] 291468 0
18/12/2013
Ethics approval number [1] 291468 0
HREC/13/Austin/245

Summary
Brief summary
The aims of this project are to: 1) conduct a prospective case series of nerve transfer surgery in eligible patients with tetraplegia; 2) implement and refine a standardised protocol for clinical and neurophysiological assessment and post-operative therapy; 3) evaluate the outcomes and cost-benefit of nerve transfers. Fifteen patients with complete or incomplete SCI between C5 and C7, who are deemed suitable for surgery by the Upper Limb Program Team, will be evaluated. Participants will undergo thorough clinical and neurophysiological assessment pre- and up to 24 months post-operatively. Donor and recipient nerve and muscle tissue samples will be examined histologically, and functional tests of upper limb performance will also be conducted. Expected outcomes include evidence of the functional effectiveness of nerve transfer surgery, refinement of selection criteria and post-operative management, cost-benefit of nerve transfer surgery , and histological information about the health of the donor and recipient nerves and muscles.
Trial website
Trial related presentations / publications
Messina A, Van Zyl N, Weymouth M, Flood S, Nunn A, Cooper C, Hahn J, Galea MP (2016) Morphology of donor and recipient nerves utilized in nerve transfer surgery to restore upper limb function after cervical spinal cord injury. Brain Sciences 6, 42; doi:10.3390/brainsci6040042
Public notes

Contacts
Principal investigator
Name 50530 0
Prof Mary Galea
Address 50530 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville VIC 3010
Country 50530 0
Australia
Phone 50530 0
+61 3 8387 2017
Fax 50530 0
Email 50530 0
m.galea@unimelb.edu.au
Contact person for public queries
Name 50531 0
Ms Natasha van Zyl
Address 50531 0
Department of Plastic and Reconstructive Surgery
Austin Health
PO Box 5555
Heidelberg VIC 3084
Country 50531 0
Australia
Phone 50531 0
+61 3 9496 3865
Fax 50531 0
Email 50531 0
info@natashavanzyl.com.au
Contact person for scientific queries
Name 50532 0
Prof Mary Galea
Address 50532 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville VIC 3010
Country 50532 0
Australia
Phone 50532 0
+61 3 8387 2017
Fax 50532 0
Email 50532 0
m.galea@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 4113 0
Van Zyl N, Hill B, Cooper C, Hahn J, Galea MP. Expanding traditional tendon-based techniques with nerve transfers for the restoration of upper limb function in tetraplegia: a prospective case series. Lancet 2019; Jul 4.
pii: S0140-6736(19)31143-2. doi: 10.1016/S0140-6736(19)31143-2.
Attachments [1] 4113 0
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
Fifty-nine nerve transfers were performed altogether (some participants had nerve transfers on both arms). Ten participants had nerve transfers combined with tendon transfers. At the two-year follow-up, participants had significant improvement in hand function and strength as well as in self-care scores. There were six adverse effects related to the surgery which had no serious functional consequences