TerminatedNCT00948025CHANGEUpdated Dec 1, 2020Results posted

A Comparative Post-marketing Study of Commercially Available Peripheral Nerve Gap Repair Options

An interventional study of Hollow tube nerve conduit, synthetic or biosynthetic and Processed Human Nerve Tissue in Traumatic Nerve Injury, sponsored by Axogen Corporation. Terminated at 4 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-01.

Sponsored by Axogen Corporation · Not applicable, Interventional, and Treatment

Why this study was terminated

transitioning from 361 HCT/P Tissue to a Biologic (BLA)

Phase: Not applicable
Study type: Interventional
Enrollment: 23
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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 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 studied

Traumatic Nerve Injury

Keywords

Peripheral Nerve Repair
Conduit
AVANCE
Neuroma Resection
Nerve Gap Repair
Digital Nerve Repair
Nerve Graft
Nerve Allograft

In context

Lead sponsor

Axogen Corporation is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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;
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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 23 participants (actual)

Study arms

Active comparator
Avance Nerve Graft
Commercially available Avance Nerve Graft for repair of nerve gap
Other: Processed Human Nerve Tissue
Active comparator
Hollow Tube Conduit
Commercially available hollow tube conduit for repair of nerve gap.
Device: Hollow tube nerve conduit, synthetic or biosynthetic

Interventions

DeviceHollow tube nerve conduit, synthetic or biosynthetic
Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
Also known as: Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex
OtherProcessed Human Nerve Tissue
Implantation of appropriate length of processed human nerve tissue at time of surgery.
Also known as: Avance Nerve Graft

What researchers measure

Primary outcomes

Recovery of Static 2-point Discrimination in the Affected Digit
Mean change in static 2-Point Discrimination between baseline and 12 months
Time frame: 12 Months

Secondary outcomes

Moving 2-point Discrimination
Percent Change from Baseline of Moving 2-Point Discriminations at Month 12
Time frame: 12 months
Semmes-Weinstein Monofilament Assessment
Percent Change from Baseline of Semmes-Weinstein Monofilament Assessment at Month 12
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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".
Time frame: 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").
Time frame: 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).
Time frame: 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).
Time frame: 12 months

Results

Posted Dec 1, 2020

Limitations and caveats

1. Early termination due to planned changes in the regulatory status of the study product from an HC/T product to a licensed biologic (planned). 2. High loss-to-follow-up rate.

Participant flow

Recruitment began on 22 June 2009 and ended on 23 May 2012.

Phase 1 (Pilot Phase)

Participant flow — Phase 1 (Pilot Phase)
Milestone	Avance Nerve Graft	Hollow Tube Conduit
Started	14	9
Completed	5	6
Not completed	9	3
Withdrew: Adverse event	1	1
Withdrew: Lost to follow-up	7	1
Withdrew: Withdrawal by subject	1	1

Phase 2 (Comparative Phase)

Participant flow — Phase 2 (Comparative Phase)
Milestone	Avance Nerve Graft	Hollow Tube Conduit
Started	0	0
Completed	0	0
Not completed	0	0

Outcome measures

PrimaryRecovery of Static 2-point Discrimination in the Affected Digit

Mean change in static 2-Point Discrimination between baseline and 12 months

Time frame:: 12 Months
Reported as:: Mean · percent change from baseline

Recovery of Static 2-point Discrimination in the Affected Digit
percent change from baseline	Avance Nerve Graft	Hollow Tube Conduit
Recovery of Static 2-point Discrimination in the Affected Digit	-65.6 ± 5.94	-31.8 ± 10.90

Statistical analysis

Avance Nerve Graft vs Hollow Tube Conduit · Wilcoxon (Mann-Whitney) · p = 0.0433 (1. a priori threshold for statistical significance set at p\<0.05. 2. the p-value was not adjusted for multiple comparisons.)

SecondaryMoving 2-point Discrimination

Percent Change from Baseline of Moving 2-Point Discriminations at Month 12

Time frame:: 12 months
Reported as:: Mean · percentage

Moving 2-point Discrimination
percentage	Avance Nerve Graft	Hollow Tube Conduit
Modified Intent to Treat population	-62.5 ± 4.78	-35.4 ± 13.71
Per protocol population	-62.5 ± 4.78	-35.4 ± 13.71

SecondarySemmes-Weinstein Monofilament Assessment

Percent Change from Baseline of Semmes-Weinstein Monofilament Assessment at Month 12

Time frame:: 12 months
Reported as:: Mean · percentage

Semmes-Weinstein Monofilament Assessment
percentage	Avance Nerve Graft	Hollow Tube Conduit
modified intent to treat	-46.1 ± 4.07	-21.1 ± 6.66
per protocol	-46.1 ± 4.07	-21.1 ± 6.66

Secondary12-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).

Time frame:: 12 months
Reported as:: Mean · score on a scale

12-month DASH Core Module Scores
score on a scale	Avance Nerve Graft	Hollow Tube Conduit
modified intent to treat	4.66 ± 2.90	7.77 ± 2.58
per protocol	4.66 ± 2.90	7.77 ± 2.58

Secondary12-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).

Time frame:: 12 month
Reported as:: Mean · score on a scale

12-month DASH (Work Module) Scores
score on a scale	Avance Nerve Graft	Hollow Tube Conduit
modified intent to treat	0.00 ± 0.00	5.22 ± 4.09
per protocol	0.00 ± 0.00	5.22 ± 4.09

Secondary12- 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).

Time frame:: 12 months
Reported as:: Mean · score on a scale

12- Month DASH (Sports/Performing Arts Module)
score on a scale	Avance Nerve Graft	Hollow Tube Conduit
modified intent-to-treat	8.33 ± 8.33	18.77 ± 9.56
per protocol	8.33 ± 8.33	18.77 ± 9.56

SecondaryPain 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".

Time frame:: 12-months
Reported as:: Mean · units on a scale

Pain at 12-months
units on a scale	Avance Nerve Graft	Hollow Tube Conduit
modified intent to treat	0.54 ± 0.28	0.92 ± 0.41
per protocol	0.54 ± 0.28	0.92 ± 0.41

SecondaryThermal 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").

Time frame:: 12-month
Reported as:: Count of participants · Participants

Thermal Discretion at 12-months
Participants	Avance Nerve Graft	Hollow Tube Conduit
Modified Intent to Treat — Yes (Thermal Discretion)	6	7
Modified Intent to Treat — No (Thermal Discretion)	0	0
Per Protocol — Yes (Thermal Discretion)	6	7
Per Protocol — No (Thermal Discretion)	0	0

SecondaryProtective 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).

Time frame:: 12 months
Reported as:: Count of participants · Participants

Protective Sensation Present at 12-months
Participants	Avance Nerve Graft	Hollow Tube Conduit
modified intent to treat — Protective Sensation Present	5	4
modified intent to treat — Protective Sensation Diminished	1	3
modified intent to treat — Protective Sensation Absent	0	2
per protocol — Protective Sensation Present	5	4
per protocol — Protective Sensation Diminished	1	3
per protocol — Protective Sensation Absent	0	2

SecondaryFunctional 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).

Time frame:: 12 months
Reported as:: Count of participants · Participants

Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
Participants	Avance Nerve Graft	Hollow Tube Conduit
modified intent to treat — S1	0	2
modified intent to treat — S2	0	0
modified intent to treat — S3	2	0
modified intent to treat — S3+	1	0
modified intent to treat — S4	3	5
per protocol — S1	0	2
per protocol — S2	0	0
per protocol — S3	2	0
per protocol — S3+	1	0
per protocol — S4	3	5

Adverse events

Collected over Adverse Events were collected from the time of randomization through 1 year.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Avance Nerve Graft	0/14 (0%)	1/14 (7.1%)	0/14 (0%)
Hollow Tube Conduit	0/9 (0%)	1/9 (11.1%)	1/9 (11.1%)

Most frequent serious events

Most frequent serious events
Event	Avance Nerve Graft	Hollow Tube Conduit
OsteomyleitisMusculoskeletal and connective tissue disorders	0/14	1/9
InfectionInfections and infestations	1/14	0/9

Most frequent other events

Most frequent other events
Event	Avance Nerve Graft	Hollow Tube Conduit
Occasional PainNervous system disorders	0/14	1/9

Baseline characteristics

All participants who were randomized and received one of the study treatments (Safety Population).

Age, Categorical
Age, Categorical(Participants)	Avance Nerve Graft	Hollow Tube Conduit	Total
<=18 years	0	0	0
Between 18 and 65 years	14	9	23
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Avance Nerve Graft	Hollow Tube Conduit	Total
Mean	45 (21 to 63)	39 (20 to 53)	41 (20 to 63)

Sex: Female, Male
Sex: Female, Male(Participants)	Avance Nerve Graft	Hollow Tube Conduit	Total
Female	2	3	5
Male	12	6	18

Region of Enrollment
Region of Enrollment(participants)	Avance Nerve Graft	Hollow Tube Conduit	Total
United States	14	9	23

Study locations

4 sites

Georgia Hand, Shoulder and Elbow
Atlanta, Georgia 30309, United States
Indiana Hand Center
Indianapolis, Indiana 46260, United States
University of Kentucky
Lexington, Kentucky 40536, United States
Curtis National Hand Center
Baltimore, Maryland 21218, United States

References and documents

Individual participant data

Plan to share: No — IPD will not be released to other researchers.

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00948025
Lead sponsor: Axogen Corporation
Responsible party: Sponsor
First posted: Jul 29, 2009
Start date: Jun 2009
Primary completion: Dec 2014
Completion: Dec 2014
Results posted: Dec 1, 2020
Last update: Dec 1, 2020

Study contacts

Erick W DeVinney

study director · Axogen Corporation

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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