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

• Sponsor: Axogen Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00948025
• Collaborator: (none)
• Enrollment: 23
• Locations: 4
• Arms: 2
• Actual Duration (Months): 66
• Patients Per Site: 5.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Nerve Injury	Device: Hollow tube nerve conduit, synthetic or biosynthetic; Other: Processed Human Nerve Tissue	N/A

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

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Avance Nerve Graft Commercially available Avance Nerve Graft for repair of nerve gap	Other: Processed Human Nerve Tissue; Implantation of appropriate length of processed human nerve tissue at time of surgery.; Other Names: Avance Nerve Graft
Active Comparator: Hollow Tube Conduit Commercially available hollow tube conduit for repair of nerve gap.	Device: Hollow tube nerve conduit, synthetic or biosynthetic; Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex); Other Names: Neurotube NeuroLac NeuraGen NeuroMatrix NeuroFlex

Outcome Measures

Primary Outcome Measures

1. Recovery of Static 2-point Discrimination in the Affected Digit [12 Months]

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

Secondary Outcome Measures

1. Moving 2-point Discrimination [12 months]

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

2. Semmes-Weinstein Monofilament Assessment [12 months]

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

3. 12-month DASH Core Module Scores [12 months]

   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).

4. 12-month DASH (Work Module) Scores [12 month]

   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).

5. 12- Month DASH (Sports/Performing Arts Module) [12 months]

   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).

6. Pain at 12-months [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".

7. Thermal Discretion at 12-months [12-month]

   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").

8. Protective Sensation Present at 12-months [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).

9. Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgia Hand, Shoulder and Elbow	Atlanta	Georgia	United States	30309
2	Indiana Hand Center	Indianapolis	Indiana	United States	46260
3	University of Kentucky	Lexington	Kentucky	United States	40536
4	Curtis National Hand Center	Baltimore	Maryland	United States	21218

Sponsors and Collaborators

• Axogen Corporation

Investigators

• Study Director: Erick W DeVinney, Axogen Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Axogen Corporation
• ClinicalTrials.gov Identifier: NCT00948025
• Other Study ID Numbers: ANG-CP-004
• First Posted: Jul 29, 2009
• Last Update Posted: Dec 1, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Axogen Corporation: Peripheral Nerve Repair; Conduit; AVANCE; Neuroma Resection; Nerve Gap Repair; Digital Nerve Repair; Nerve Graft; Nerve Allograft

Study Results

Participant Flow

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

Arm/Group Title	Avance Nerve Graft	Hollow Tube Conduit
Arm/Group Description	Commercially available Avance Nerve Graft for repair of nerve gap Processed Human Nerve Tissue Scaffold: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery.	Commercially available hollow tube conduit for repair of nerve gap. Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
Period Title: Phase 1 (Pilot Phase)
STARTED	14	9
COMPLETED	5	6
NOT COMPLETED	9	3
Period Title: Phase 1 (Pilot Phase)
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Avance Nerve Graft	Hollow Tube Conduit	Total
Arm/Group Description	Commercially available Avance Nerve Graft for repair of nerve gap Processed Human Nerve Tissue: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery.	Commercially available hollow tube conduit for repair of nerve gap. Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)	Total of all reporting groups
Overall Participants	14	9	23
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 100%	9 100%	23 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	45	39	41
Sex: Female, Male (Count of Participants)
Female	2 14.3%	3 33.3%	5 21.7%
Male	12 85.7%	6 66.7%	18 78.3%
Region of Enrollment (participants) [Number]
United States	14 100%	9 100%	23 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Number of subjects

Arm/Group Title	Avance Nerve Graft	Hollow Tube Conduit
Arm/Group Description	Commercially available Avance Nerve Graft for repair of nerve gap Processed Human Nerve Tissue Scaffold: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery.	Commercially available hollow tube conduit for repair of nerve gap. Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
Measure Participants	6	9
Mean (Standard Error) [percent change from baseline]	-65.6 (5.94)	-31.8 (10.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Avance Nerve Graft, Hollow Tube Conduit
	Comments	P-value comparing static 2-point discrimination per visit derived from mixed linear modeling of longitudinal data. P-Value is based on Mann-Whitney U test.
	Type of Statistical Test	Other
	Comments	Mann-Whitney U test was used to derive p-values.
Statistical Test of Hypothesis	p-Value	0.0433
	Comments	a priori threshold for statistical significance set at p<0.05. the p-value was not adjusted for multiple comparisons.
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Moving 2-point Discrimination
Description	Percent Change from Baseline of Moving 2-Point Discriminations at Month 12
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Arm/Group Title	Avance Nerve Graft	Hollow Tube Conduit
Arm/Group Description	Commercially available Avance Nerve Graft for repair of nerve gap Processed Human Nerve Tissue: Implantation of appropriate length of processed human nerve tissue at time of surgery.	Commercially available hollow tube conduit for repair of nerve gap. Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
Measure Participants	6	9
Modified Intent to Treat population	-62.5 (4.78)	-35.4 (13.71)
Per protocol population	-62.5 (4.78)	-35.4 (13.71)

3. Secondary Outcome

Title	Semmes-Weinstein Monofilament Assessment
Description	Percent Change from Baseline of Semmes-Weinstein Monofilament Assessment at Month 12
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Arm/Group Title	Avance Nerve Graft	Hollow Tube Conduit
Arm/Group Description	Commercially available Avance Nerve Graft for repair of nerve gap Processed Human Nerve Tissue Scaffold: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery.	Commercially available hollow tube conduit for repair of nerve gap. Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
Measure Participants	6	9
modified intent to treat	-46.1 (4.07)	-21.1 (6.66)
per protocol	-46.1 (4.07)	-21.1 (6.66)

4. Secondary Outcome

Title	12-month DASH Core Module Scores
Description	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

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Arm/Group Title	Avance Nerve Graft	Hollow Tube Conduit
Arm/Group Description	Commercially available Avance Nerve Graft for repair of nerve gap Processed Human Nerve Tissue Scaffold: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery.	Commercially available hollow tube conduit for repair of nerve gap. Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
Measure Participants	5	6
modified intent to treat	4.66 (2.90)	7.77 (2.58)
per protocol	4.66 (2.90)	7.77 (2.58)

5. Secondary Outcome

Title	12-month DASH (Work Module) Scores
Description	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

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Arm/Group Title	Avance Nerve Graft	Hollow Tube Conduit
Arm/Group Description	Commercially available Avance Nerve Graft for repair of nerve gap Processed Human Nerve Tissue Scaffold: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery.	Commercially available hollow tube conduit for repair of nerve gap. Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
Measure Participants	4	6
modified intent to treat	0.00 (0.00)	5.22 (4.09)
per protocol	0.00 (0.00)	5.22 (4.09)

6. Secondary Outcome

Title	12- Month DASH (Sports/Performing Arts Module)
Description	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

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Arm/Group Title	Avance Nerve Graft	Hollow Tube Conduit
Arm/Group Description	Commercially available Avance Nerve Graft for repair of nerve gap Processed Human Nerve Tissue Scaffold: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery.	Commercially available hollow tube conduit for repair of nerve gap. Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
Measure Participants	3	3
modified intent-to-treat	8.33 (8.33)	18.77 (9.56)
per protocol	8.33 (8.33)	18.77 (9.56)

7. Secondary Outcome

Title	Pain at 12-months
Description	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

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Arm/Group Title	Avance Nerve Graft	Hollow Tube Conduit
Arm/Group Description	Commercially available Avance Nerve Graft for repair of nerve gap Processed Human Nerve Tissue Scaffold: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery.	Commercially available hollow tube conduit for repair of nerve gap. Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
Measure Participants	5	6
modified intent to treat	0.54 (0.28)	0.92 (0.41)
per protocol	0.54 (0.28)	0.92 (0.41)

8. Secondary Outcome

Title	Thermal Discretion at 12-months
Description	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

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Arm/Group Title	Avance Nerve Graft	Hollow Tube Conduit
Arm/Group Description	Commercially available Avance Nerve Graft for repair of nerve gap Processed Human Nerve Tissue Scaffold: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery.	Commercially available hollow tube conduit for repair of nerve gap. Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
Measure Participants	6	7
Yes (Thermal Discretion)	6 42.9%	7 77.8%
No (Thermal Discretion)	0 0%	0 0%
Yes (Thermal Discretion)	6 42.9%	7 77.8%
No (Thermal Discretion)	0 0%	0 0%

9. Secondary Outcome

Title	Protective Sensation Present at 12-months
Description	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

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Arm/Group Title	Avance Nerve Graft	Hollow Tube Conduit
Arm/Group Description	Commercially available Avance Nerve Graft for repair of nerve gap Processed Human Nerve Tissue Scaffold: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery.	Commercially available hollow tube conduit for repair of nerve gap. Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
Measure Participants	6	9
Protective Sensation Present	5 35.7%	4 44.4%
Protective Sensation Diminished	1 7.1%	3 33.3%
Protective Sensation Absent	0 0%	2 22.2%
Protective Sensation Present	5 35.7%	4 44.4%
Protective Sensation Diminished	1 7.1%	3 33.3%
Protective Sensation Absent	0 0%	2 22.2%

10. Secondary Outcome

Title	Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
Description	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

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Arm/Group Title	Avance Nerve Graft	Hollow Tube Conduit
Arm/Group Description	Commercially available Avance Nerve Graft for repair of nerve gap Processed Human Nerve Tissue Scaffold: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery.	Commercially available hollow tube conduit for repair of nerve gap. Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
Measure Participants	6	7
S1	0 0%	2 22.2%
S2	0 0%	0 0%
S3	2 14.3%	0 0%
S3+	1 7.1%	0 0%
S4	3 21.4%	5 55.6%
S1	0 0%	2 22.2%
S2	0 0%	0 0%
S3	2 14.3%	0 0%
S3+	1 7.1%	0 0%
S4	3 21.4%	5 55.6%

Adverse Events

Time Frame	Adverse Events were collected from the time of randomization through 1 year.
Arm/Group Title	Avance Nerve Graft		Hollow Tube Conduit
Arm/Group Description	Commercially available Avance Nerve Graft for repair of nerve gap Processed Human Nerve Tissue: Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery.		Commercially available hollow tube conduit for repair of nerve gap. Hollow tube nerve conduit, synthetic or biosynthetic: Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
All Cause Mortality
	Avance Nerve Graft		Hollow Tube Conduit
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/9 (0%)
Serious Adverse Events
	Avance Nerve Graft		Hollow Tube Conduit
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/14 (7.1%)		1/9 (11.1%)
Infections and infestations
Infection	1/14 (7.1%)	1	0/9 (0%)	0
Musculoskeletal and connective tissue disorders
Osteomyleitis	0/14 (0%)	0	1/9 (11.1%)	1
Other (Not Including Serious) Adverse Events
	Avance Nerve Graft		Hollow Tube Conduit
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		1/9 (11.1%)
Nervous system disorders
Occasional Pain	0/14 (0%)	0	1/9 (11.1%)	1

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.