Nerve TransferNCT06596629
Nerve Transfers for Restoration of Hand Function in Cervical Spinal Cord Injury: Effects and Influencing Factors
An observational study of Nerve Transfer, run by Roessingh Research and Development at 1 site in Netherlands.
Trial summary
The goal of this observational study is to learn about influencing factors on the clinical outcomes of nerve transfers used to restore hand function in patients with cervical spinal cord injury (CSCI). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Nerve Transfer
- How many people
- 19 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a cervical spinal cord injury, ≥ 12 years and older, who underwent single or multiple nerve transfers in one or both upper limbs to reanimate the posterior interosseus nerve (PIN) and/or anterior interosseus nerve (AIN).
Who may be able to join
- patients with cervical spinal cord injury
- single or multiple nerve transfers in one or both upper limbs to reanimate the posterior interosseus nerve (PIN) or anterior interosseus nerve (AIN).
- Surgery performed in Medical Spectrum Twente (MST) in Enschede.
- Postoperative treatment in Roessingh, Centre for Rehabilitation (RCR) in Enschede.
- Surgeries performed between February 2019 and February 2024.
Who cannot join
- patients with pre-existing neurological comorbidities
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Roessingh, Centre for Rehabilitation
Enschede, Overijssel, 7522AH
About this study
Official title: Nerve Transfers (reinnervation of the Posterior Interosseus Nerve and Anterior Interosseus Nerve) in Patients with Cervical Spinal Cord Injury: Duration Until Effect, Influence of Age and Impact of Time to Surgery on the Effect
The goal of this observational study is to learn about influencing factors on the clinical outcomes of nerve transfers used to restore hand function in patients with cervical spinal cord injury (CSCI). Specifically, the study focuses on the reinnervation of the posterior interosseus nerve (PIN) and the anterior interosseus nerve (AIN).
The main questions it aims to answer are:
Read more
- What is the duration after nerve transfer surgery until effect is achieved?
- What is the influence of the participants age during surgery on the effect of a nerve transfer?
- What is the impact of time interval from the date of spinal cord injury to the date of nerve transfer surgery?
Participants are not directly involved in this study since data will be retrospectively collected from the Electronic Patients Records (EPD).
Read the detailed description
Spinal cord injury (SCI) has a profound impact on the quality of life. Patients with a cervical spinal cord injury (CSCI) additionally suffer from upper extremity impairments, leading to increased dependence on others for daily life activities and a further decline in quality of life. For many patients, improvement of hand function is therefore the highest-ranked goal in rehabilitation after CSCI. Conventionally, tendon transfers have been widely used to reconstruct upper extremity function. Over the past decade, there has been growing interest in employing nerve transfer techniques for reconstruction of upper limb function in tetraplegia. Specifically for reconstruction of hand function, reinnervation of the posterior interosseus nerve (PIN) provides restoration of extension of fingers and thumb, while reinnervation of the anterior interosseus nerve (AIN) is intended to restore flexion of thumb, index finger and middle finger.
Since previous studies already reported success rates for the different nerve transfers, this study will mainly focus on the factors influencing the clinical outcomes of the reinnervation of PIN and AIN in patients with cervical spinal cord injury. Specifically, the study will focus on the impact of age during surgery and the interval between spinal cord injury and surgery on clinical outcomes.
In this single-center retrospective case series, data will be collected from patients with a cervical spinal cord injury who underwent single or multiple nerve transfers in one or both upper limbs to reanimate the PIN and/or AIN. Informed consent is not required, as this study involves a retrospective analysis of anonymized data without any direct intervention or interaction with patients.
Data will be extracted from the Electronic Patient Records (EPD) at Roessingh. This data will be anonymized, by using exclusive numbers for all patients. The identifying information will be kept in a separate list only accessible by the lead researcher. In all analyses, only the patient specific codes will be used.
Baseline data will include age, gender and smoking habits. SCI related data compromises the date of injury, mechanism of injury, neurological level, motor level, grade of International Classification of Surgery of the Hand in Tetraplegia (ICSHT) and the American Spinal Injury Association (ASIA) grade. The specific surgeries performed and their dates will be recorded. Patients records will be reviewed to determine the dates of when the effect of nerve transfers were observed. Additionally, the number of treated limbs and the number of patients with limiting spasticity or restricted range of motion in the hands will be documented.
As this is a retrospective study, some data may be missing, and variables will be reported as such. Data that is uninterpretable will also be reported as missing.
All adverse events and serious adverse events will be recorded.
Statistical analysis: kaplan-Meier survival analysis will be used to estimate the time until effect of nerve transfers occured. Spearman rank correlations will be used to assess the relationship between the variables, specifically between the results of nerve transfers and \'age during surgery\' and \'time between spinal cord injury and nerve transfer surgery\'.
- Conditions
- Nerve Transfer
- Keywords
- spinal cord injury, tetraplegia, posterior interosseus nerve, anterior interosseus nerve, hand function
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration until result of nerve transfers
Defined as the time until 'first result' or 'desired result' is achieved following nerve transfer surgery.
First result: defined as the first visible muscle contraction in the reinnervated muscles. For the posterior interosseus nerve (PIN), this includes any contraction of thumb and/or finger extension. For the anterior interosseus nerve (AIN), this refers to any visible flexion of thumb, index finger and middle fingers .
Desired result: for reanimation of the posterior interosseus nerve (PIN), this is defined as the patient's ability to extent the thumb and fingers sufficiently to achieve a desirable hand opening. Successful reinnervation of the anterior interosseus nerve (AIN) will be documented when patients are able to flex the thumb and fingers to form a fist.
Dates of first result, desired result and date of surgery will be extracted from patient's records.
Duration after surgery until 'first result' and 'desired result' will be expressed in months.
Measured: up to 4 weeks
Secondary outcomes (2)
Age during surgery
The influence of age during surgery on the results of nerve transfers will be assessed.
Patients records will be reviewed to extract the following information: birth date, surgery date and dates of first result en desired result. To determine the age of the patient at the time of surgery, the difference between the date of birth and the date of surgery will be calculated .
Age during surgery will be expressed in years.
Hypothesis: younger patients are expected to achieve earlier and better outcomes from nerve transfer surgery.
Measured: Up to 4 weeks
Time between spinal cord injury and nerve transfer surgery
The influence of time to surgery on the results of nerve transfers will be assessed.
Patient\'s records will be reviewed to extract the following information: spinal cord injury date, surgery date and dates of first result and desired result. Time between spinal cord injury date and surgery date will be expressed in months.
Hypotheses: surgeries performed within 12 months after spinal cord injury will result in earlier and better outcomes from nerve transfer surgery.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve TransferStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roessingh Research and Development
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nora W Jacobs, MD, Study chair, Roessingh,Centre for Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596629
- Sponsor's protocol ID
- 2024-17418
- Status last verified
- Jan 2025
- First submitted
- 29 Aug 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Transfers (reinnervation of the Posterior Interosseus Nerve and Anterior Interosseus Nerve) in Patients with Cervical Spinal Cord Injury: Duration Until Effect, Influence of Age and Impact of Time to Surgery on the Effect
- ClinicalTrials.gov ID
- NCT06596629
- Acronym / sponsor ID
- 2024-17418
- Conditions
- Nerve Transfer
- Keywords
- spinal cord injury, tetraplegia, posterior interosseus nerve, anterior interosseus nerve, hand function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Roessingh Research and DevelopmentUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about influencing factors on the clinical outcomes of nerve transfers used to restore hand function in patients with cervical spinal cord injury (CSCI). Specifically, the study focuses on the reinnervation of the posterior interosseus nerve (PIN) and the anterior interosseus nerve (AIN).
The main questions it aims to answer are:
- What is the duration after nerve transfer surgery until effect is achieved?
- What is the influence of the participants age during surgery on the effect of a nerve transfer?
- What is the impact of time interval from the date of spinal cord injury to the date of nerve transfer surgery?
Participants are not directly involved in this study since data will be retrospectively collected from the Electronic Patients Records (EPD).
Detailed description
Spinal cord injury (SCI) has a profound impact on the quality of life. Patients with a cervical spinal cord injury (CSCI) additionally suffer from upper extremity impairments, leading to increased dependence on others for daily life activities and a further decline in quality of life. For many patients, improvement of hand function is therefore the highest-ranked goal in rehabilitation after CSCI. Conventionally, tendon transfers have been widely used to reconstruct upper extremity function. Over the past decade, there has been growing interest in employing nerve transfer techniques for reconstruction of upper limb function in tetraplegia. Specifically for reconstruction of hand function, reinnervation of the posterior interosseus nerve (PIN) provides restoration of extension of fingers and thumb, while reinnervation of the anterior interosseus nerve (AIN) is intended to restore flexion of thumb, index finger and middle finger.
Since previous studies already reported success rates for the different nerve transfers, this study will mainly focus on the factors influencing the clinical outcomes of the reinnervation of PIN and AIN in patients with cervical spinal cord injury. Specifically, the study will focus on the impact of age during surgery and the interval between spinal cord injury and surgery on clinical outcomes.
In this single-center retrospective case series, data will be collected from patients with a cervical spinal cord injury who underwent single or multiple nerve transfers in one or both upper limbs to reanimate the PIN and/or AIN. Informed consent is not required, as this study involves a retrospective analysis of anonymized data without any direct intervention or interaction with patients.
Data will be extracted from the Electronic Patient Records (EPD) at Roessingh. This data will be anonymized, by using exclusive numbers for all patients. The identifying information will be kept in a separate list only accessible by the lead researcher. In all analyses, only the patient specific codes will be used.
Baseline data will include age, gender and smoking habits. SCI related data compromises the date of injury, mechanism of injury, neurological level, motor level, grade of International Classification of Surgery of the Hand in Tetraplegia (ICSHT) and the American Spinal Injury Association (ASIA) grade. The specific surgeries performed and their dates will be recorded. Patients records will be reviewed to determine the dates of when the effect of nerve transfers were observed. Additionally, the number of treated limbs and the number of patients with limiting spasticity or restricted range of motion in the hands will be documented.
As this is a retrospective study, some data may be missing, and variables will be reported as such. Data that is uninterpretable will also be reported as missing.
All adverse events and serious adverse events will be recorded.
Statistical analysis: kaplan-Meier survival analysis will be used to estimate the time until effect of nerve transfers occured. Spearman rank correlations will be used to assess the relationship between the variables, specifically between the results of nerve transfers and \'age during surgery\' and \'time between spinal cord injury and nerve transfer surgery\'.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a cervical spinal cord injury, ≥ 12 years and older, who underwent single or multiple nerve transfers in one or both upper limbs to reanimate the posterior interosseus nerve (PIN) and/or anterior interosseus nerve (AIN).
Key inclusion criteria (5 listed)
- patients with cervical spinal cord injury
- single or multiple nerve transfers in one or both upper limbs to reanimate the posterior interosseus nerve (PIN) or anterior interosseus nerve (AIN).
- Surgery performed in Medical Spectrum Twente (MST) in Enschede.
- Postoperative treatment in Roessingh, Centre for Rehabilitation (RCR) in Enschede.
- Surgeries performed between February 2019 and February 2024.
Key exclusion criteria (1 listed)
- patients with pre-existing neurological comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration until result of nerve transfers
Time frame: up to 4 weeks
Defined as the time until 'first result' or 'desired result' is achieved following nerve transfer surgery. First result: defined as the first visible muscle contraction in the reinnervated muscles. For the posterior interosseus nerve (PIN), this includes any contraction of thumb and/or finger extension. For the anterior interosseus nerve (AIN), this refers to any visible flexion of thumb, index finger and middle fingers . Desired result: for reanimation of the posterior interosseus nerve (PIN), this is defined as the patient's ability to extent the thumb and fingers sufficiently to achieve a desirable hand opening. Successful reinnervation of the anterior interosseus nerve (AIN) will be documented when patients are able to flex the thumb and fingers to form a fist. Dates of first result, desired result and date of surgery will be extracted from patient's records. Duration after surgery until 'first result' and 'desired result' will be expressed in months.
2 secondary outcomes
Age during surgery
Time frame: Up to 4 weeks
Time between spinal cord injury and nerve transfer surgery
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora W Jacobs, MD study chair
Roessingh,Centre for Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nerve Transfer, run by Roessingh Research and Development at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration until result of nerve transfers (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.