Traumatic Nerve InjuryCHANGENCT00948025
A Comparative Post-marketing Study of Commercially Available Peripheral Nerve Gap Repair Options
A study testing Hollow tube nerve conduit, synthetic or biosynthetic and Processed Human Nerve Tissue in people with Traumatic Nerve Injury, run by Axogen Corporation at 4 sites in United States.
Trial summary
This study is a comparison of sensory recovery outcomes following the use of AVANCE Nerve Graft or hollow tube conduit for peripheral nerve gap repairs in the hand. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Nerve Injury
- What is being tested?
- Hollow tube nerve conduit, synthetic or biosynthetic and Processed Human Nerve Tissue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2009to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Require primary or secondary nerve injury repair with Hollow Nerve Conduit or AVANCE™ in at least 1 digital nerve;
- Undergo End to End nerve to nerve graft coaptation on both the proximal and distal portion of the nerve gap in the AVANCE™ group or nerve entubulation in the Hollow Nerve Conduit group;
- Be willing to comply with all aspects of the treatment and evaluation schedule over a 12 Month duration; and
- Sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures.
Who cannot join
- Nerve gaps of < 5 mm or > 20 mm;
- Estimated distance of regeneration of >125 mm (distance from injury site to sensory target)
- Nerve crush or avulsion injuries;
- Incomplete nerve transections;
- Injury requiring replantation of target digit;
- Contralateral digital injuries corresponding to the target digit;
Show all 18Show fewer
- Nerve injuries in the affected limb proximal to the crease of the wrist;
- End to side nerve repair;
- Injuries with significant vascular damage which may impair adequate perfusion of the target limb;
- Subjects who are undergoing treatment with chemotherapy, radiation therapy, or other know treatment which affects the growth of neural and/or vascular system;
- Use of bovine collagen based hollow nerve conduit in a subject with known or suspected bovine sensitivity;
- Subjects age ≤18 years or ≥70 years;
- History neuropathy, diabetic or any other known neuropathy;
- Secondary nerve repair >12 weeks post initial injury;
- Currently enrolled in another investigational study;
- Expected use of medications during the study that are known to cause peripheral neuropathy;
- History or Reynaud's or other disorder known to compromise circulation or sensation in the upper extremity; and
- Any subject who at the discretion of the Investigator is not suitable for inclusion in the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Georgia Hand, Shoulder and Elbow
Atlanta, Georgia, 30309
Curtis National Hand Center
Baltimore, Maryland, 21218
Indiana Hand Center
Indianapolis, Indiana, 46260
University of Kentucky
Lexington, Kentucky, 40536
About this study
Official title: A Multicenter, Prospective, Randomized, Comparative Study of Hollow Nerve Conduit and Avance Nerve Graft Evaluating Recovery Outcomes of Nerve Repair in the Hand. (CHANGE)
This study is a comparison of sensory recovery outcomes following the use of AVANCE Nerve Graft or hollow tube conduit for peripheral nerve gap repairs in the hand.
Read the detailed description
The CHANGE study is a post-marketing study designed as a prospective, single-blind, randomized, two phase study comparing clinical outcomes of AVANCE Nerve Graft to hollow tube conduits. The first phase (pilot phase) assesses projected differences expected between two treatment groups. The second phase of the study provides comparison data between the two treatment groups.
AVANCE Nerve Graft is current regulated in the United States as a 361 HCT/P Tissue for transplantation; not a Drug, Biologic, or Medical Device. Hollow tube conduits are currently regulated in the United States as medical devices.
- Conditions
- Traumatic Nerve Injury
- Being tested
- Hollow tube nerve conduit, synthetic or biosynthetic, Processed Human Nerve Tissue
- Keywords
- Peripheral Nerve Repair, Conduit, AVANCE, Neuroma Resection, Nerve Gap Repair, Digital Nerve Repair, Nerve Graft, Nerve Allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hollow tube nerve conduit, synthetic or biosyntheticDevice
Also called Neurotube, NeuroLac, NeuraGen, NeuroMatrix
Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
Processed Human Nerve TissueOther
Also called Avance Nerve Graft
Implantation of appropriate length of processed human nerve tissue at time of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Avance Nerve Graft | Active comparator | Commercially available Avance Nerve Graft for repair of nerve gap Receives: Other: Processed Human Nerve Tissue |
| Hollow Tube Conduit | Active comparator | Commercially available hollow tube conduit for repair of nerve gap. Receives: Device: Hollow tube nerve conduit, synthetic or biosynthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of Static 2-point Discrimination in the Affected Digit
Mean change in static 2-Point Discrimination between baseline and 12 months
Measured: 12 Months
Secondary outcomes (9)
Moving 2-point Discrimination
Percent Change from Baseline of Moving 2-Point Discriminations at Month 12
Measured: 12 months
Semmes-Weinstein Monofilament Assessment
Percent Change from Baseline of Semmes-Weinstein Monofilament Assessment at Month 12
Measured: 12 months
12-month DASH Core Module Scores
Summary of Disability of the Arm, Shoulder, and Hand (DASH) scores (Core Module) at Month 12
The Disabilities of the Arm, Shoulder and Hand (DASH) core module questionnaire is a 30-item questionnaire includes 21 physical function items, 6 symptom items, and 3 social/role function items. It is a patient reported questionnaire used to assess physical function and severity of symptoms in patients with musculoskeletal disorders of the upper limb. Each of the items in the DASH use a 5-point Likert scale to assess the corresponding severity or functional parameter. The outcome measure is scored based on the formula ([sum of n responses)/ - 30 (minimum score]/1.2 (range of scores ÷100), where n represents the number of completed items. Computed scores range from 0 (no disability) to 100 (most severe disability).
Measured: 12 months
12-month DASH (Work Module) Scores
Summary of Disability of the Arm, Shoulder, and Hand (DASH) scores (Work Module) at Month 12
The Disabilities of the Arm, Shoulder and Hand (DASH) Work Module questionnaire is a 4-item questionnaire used to identify the job-specific difficulties that workers might experience but which may not affect their activities of daily living. It is a patient reported questionnaire used to assess the impact that musculoskeletal disorders of the upper limb have on a patient's ability to perform work-related tasks. Each of the items in the DASH Work Module use a 5-point Likert scale to assess the corresponding severity or functional parameter. The outcome measure is scored based on the formula ([sum of n responses)/ - 4 (minimum score]/0.16 (range of scores ÷100), where n represents the number of completed items. Computed scores range from 0 (no difficulty) to 100 (most severe difficulty).
Measured: 12 month
12- Month DASH (Sports/Performing Arts Module)
Summary of Disability of the Arm, Shoulder, and Hand (DASH) scores (Sports/Performing Arts Module) at month 12
The Disabilities of the Arm, Shoulder and Hand (DASH) Sports/Performing Arts Module questionnaire is a 4-item questionnaire used to identify the specific difficulties that professional athletes/performing artists might experience but which may not affect their activities of daily living. It is a patient reported questionnaire used to assess the impact that musculoskeletal disorders of the upper limb have on a patient's ability to perform sports or play a musical instrument. Each of the items in the DASH use a 5-point Likert scale to assess the corresponding severity or functional parameter. The outcome measure is scored based on the formula ([sum of n responses)/ - 4 (minimum score]/0.16 (range of scores ÷100), where n represents the number of completed items. Computed scores range from 0 (no difficulty) to 100 (most severe difficulty).
Measured: 12 months
Pain at 12-months
Summary of Pain Assessment using Visual Analogue Scale (VAS) at Month 12
The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10 centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the subject is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing no pain and 100 millimeters representing "the worst pain imaginable".
Measured: 12-months
Thermal Discretion at 12-months
Summary of Thermal Discretion at Month 12 as determined by the Investigator.
Thermal discretion was assessed by applying a hot and/or cold object to the patient's affected digit. Thermal discretion was reported as either present ("Yes") or not present ("No").
Measured: 12-month
Protective Sensation Present at 12-months
Summary of Protective Sensation by Month 12
Semmes-Weinstein Monofilament (SWMF) assessment of protective sensation. The gauge of the monofilaments range from 2.83 (normal) to 6.65 (deep pressure sensation only). Protective Sensation Present (SWMF score of 3.61 or better), Protective Sensation Diminished (SWMF score of 4.31-3.84), Protective Sensation Absent (SWMF score of 4.56 or greater).
Measured: 12 months
Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
Summary of Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
Patients were assessed for functional recovery of sensation on a scale from S0 to S4 with S0 representing absence of sensibility, S1 representing recovery of deep cutaneous pain sensibility, S2 representing the return of some degree of superficial cutaneous pain and tactile sensibility, S3 representing return of superficial cutaneous pain and tactile sensibility, S3+ representing return of sensibility as in S3 and some recovery of 2-point discrimination (a 2-PD score between 7-15mm), and S4 representing complete recovery of normal sensation as assessed by 2-point discrimination (score between 2-6mm).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: transitioning from 361 HCT/P Tissue to a Biologic (BLA)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Traumatic Nerve InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axogen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erick W DeVinney, Study director, Axogen Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948025
- Sponsor's protocol ID
- ANG-CP-004
- Acronym
- CHANGE
- Status last verified
- Nov 2020
- First submitted
- 17 Jul 2009
- Last updated
- 1 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be released to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Comparative Study of Hollow Nerve Conduit and Avance Nerve Graft Evaluating Recovery Outcomes of Nerve Repair in the Hand. (CHANGE)
- ClinicalTrials.gov ID
- NCT00948025
- Acronym / sponsor ID
- CHANGE / ANG-CP-004
- Conditions
- Traumatic Nerve Injury
- Keywords
- Peripheral Nerve Repair, Conduit, AVANCE, Neuroma Resection, Nerve Gap Repair, Digital Nerve Repair, Nerve Graft, Nerve Allograft
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: transitioning from 361 HCT/P Tissue to a Biologic (BLA)
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Axogen CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2009 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Posted 1 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a comparison of sensory recovery outcomes following the use of AVANCE Nerve Graft or hollow tube conduit for peripheral nerve gap repairs in the hand.
Detailed description
The CHANGE study is a post-marketing study designed as a prospective, single-blind, randomized, two phase study comparing clinical outcomes of AVANCE Nerve Graft to hollow tube conduits. The first phase (pilot phase) assesses projected differences expected between two treatment groups. The second phase of the study provides comparison data between the two treatment groups.
AVANCE Nerve Graft is current regulated in the United States as a 361 HCT/P Tissue for transplantation; not a Drug, Biologic, or Medical Device. Hollow tube conduits are currently regulated in the United States as medical devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avance Nerve Graft | Active comparator | Other: Processed Human Nerve TissueCommercially available Avance Nerve Graft for repair of nerve gap |
| Hollow Tube Conduit | Active comparator | Device: Hollow tube nerve conduit, synthetic or biosyntheticCommercially available hollow tube conduit for repair of nerve gap. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Require primary or secondary nerve injury repair with Hollow Nerve Conduit or AVANCE™ in at least 1 digital nerve;
- Undergo End to End nerve to nerve graft coaptation on both the proximal and distal portion of the nerve gap in the AVANCE™ group or nerve entubulation in the Hollow Nerve Conduit group;
- Be willing to comply with all aspects of the treatment and evaluation schedule over a 12 Month duration; and
- Sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures.
Key exclusion criteria (18 listed)
- Nerve gaps of < 5 mm or > 20 mm;
- Estimated distance of regeneration of >125 mm (distance from injury site to sensory target)
- Nerve crush or avulsion injuries;
- Incomplete nerve transections;
- Injury requiring replantation of target digit;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hollow tube nerve conduit, synthetic or biosyntheticAlso: Neurotube, NeuroLac, NeuraGen, NeuroMatrixAppropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex) | Device | Hollow Tube Conduit |
| Processed Human Nerve TissueAlso: Avance Nerve GraftImplantation of appropriate length of processed human nerve tissue at time of surgery. | Other | Avance Nerve Graft |
Primary outcome
Recovery of Static 2-point Discrimination in the Affected Digit
Time frame: 12 Months
Mean change in static 2-Point Discrimination between baseline and 12 months
9 secondary outcomes
Moving 2-point Discrimination
Time frame: 12 months
Semmes-Weinstein Monofilament Assessment
Time frame: 12 months
12-month DASH Core Module Scores
Time frame: 12 months
12-month DASH (Work Module) Scores
Time frame: 12 month
12- Month DASH (Sports/Performing Arts Module)
Time frame: 12 months
Pain at 12-months
Time frame: 12-months
Thermal Discretion at 12-months
Time frame: 12-month
Protective Sensation Present at 12-months
Time frame: 12 months
Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD will not be released to other researchers.
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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.
Erick W DeVinney study director
Axogen Corporation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hollow tube nerve conduit, synthetic or biosynthetic and Processed Human Nerve Tissue in people with Traumatic Nerve Injury, run by Axogen Corporation at 4 sites in United States.
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 4 inclusion and 18 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: stopped early, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 1 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recovery of Static 2-point Discrimination in the Affected Digit (time frame: 12 Months). 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 1 Dec 2020.