Trial Outcomes & Findings for A Comparative Post-marketing Study of Commercially Available Peripheral Nerve Gap Repair Options (NCT NCT00948025)
NCT ID: NCT00948025
Last Updated: 2020-12-01
Results Overview
Mean change in static 2-Point Discrimination between baseline and 12 months
TERMINATED
NA
23 participants
12 Months
2020-12-01
Participant Flow
Recruitment began on 22 June 2009 and ended on 23 May 2012.
Participant milestones
| Measure |
Avance Nerve Graft
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.
|
Hollow Tube Conduit
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)
|
|---|---|---|
|
Phase 1 (Pilot Phase)
STARTED
|
14
|
9
|
|
Phase 1 (Pilot Phase)
COMPLETED
|
5
|
6
|
|
Phase 1 (Pilot Phase)
NOT COMPLETED
|
9
|
3
|
|
Phase 2 (Comparative Phase)
STARTED
|
0
|
0
|
|
Phase 2 (Comparative Phase)
COMPLETED
|
0
|
0
|
|
Phase 2 (Comparative Phase)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Avance Nerve Graft
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.
|
Hollow Tube Conduit
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)
|
|---|---|---|
|
Phase 1 (Pilot Phase)
Adverse Event
|
1
|
1
|
|
Phase 1 (Pilot Phase)
Lost to Follow-up
|
7
|
1
|
|
Phase 1 (Pilot Phase)
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Comparative Post-marketing Study of Commercially Available Peripheral Nerve Gap Repair Options
Baseline characteristics by cohort
| Measure |
Avance Nerve Graft
n=14 Participants
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.
|
Hollow Tube Conduit
n=9 Participants
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
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45 years
n=5 Participants
|
39 years
n=7 Participants
|
41 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
9 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Number of subjects
Mean change in static 2-Point Discrimination between baseline and 12 months
Outcome measures
| Measure |
Avance Nerve Graft
n=6 Participants
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.
|
Hollow Tube Conduit
n=9 Participants
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)
|
|---|---|---|
|
Recovery of Static 2-point Discrimination in the Affected Digit
|
-65.6 percent change from baseline
Standard Error 5.94
|
-31.8 percent change from baseline
Standard Error 10.90
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Percent Change from Baseline of Moving 2-Point Discriminations at Month 12
Outcome measures
| Measure |
Avance Nerve Graft
n=6 Participants
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.
|
Hollow Tube Conduit
n=9 Participants
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)
|
|---|---|---|
|
Moving 2-point Discrimination
Modified Intent to Treat population
|
-62.5 percentage
Standard Error 4.78
|
-35.4 percentage
Standard Error 13.71
|
|
Moving 2-point Discrimination
Per protocol population
|
-62.5 percentage
Standard Error 4.78
|
-35.4 percentage
Standard Error 13.71
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Percent Change from Baseline of Semmes-Weinstein Monofilament Assessment at Month 12
Outcome measures
| Measure |
Avance Nerve Graft
n=6 Participants
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.
|
Hollow Tube Conduit
n=9 Participants
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)
|
|---|---|---|
|
Semmes-Weinstein Monofilament Assessment
modified intent to treat
|
-46.1 percentage
Standard Error 4.07
|
-21.1 percentage
Standard Error 6.66
|
|
Semmes-Weinstein Monofilament Assessment
per protocol
|
-46.1 percentage
Standard Error 4.07
|
-21.1 percentage
Standard Error 6.66
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Avance Nerve Graft
n=5 Participants
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.
|
Hollow Tube Conduit
n=6 Participants
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)
|
|---|---|---|
|
12-month DASH Core Module Scores
modified intent to treat
|
4.66 score on a scale
Standard Error 2.90
|
7.77 score on a scale
Standard Error 2.58
|
|
12-month DASH Core Module Scores
per protocol
|
4.66 score on a scale
Standard Error 2.90
|
7.77 score on a scale
Standard Error 2.58
|
SECONDARY outcome
Timeframe: 12 monthPopulation: 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.
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).
Outcome measures
| Measure |
Avance Nerve Graft
n=4 Participants
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.
|
Hollow Tube Conduit
n=6 Participants
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)
|
|---|---|---|
|
12-month DASH (Work Module) Scores
modified intent to treat
|
0.00 score on a scale
Standard Error 0.00
|
5.22 score on a scale
Standard Error 4.09
|
|
12-month DASH (Work Module) Scores
per protocol
|
0.00 score on a scale
Standard Error 0.00
|
5.22 score on a scale
Standard Error 4.09
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Avance Nerve Graft
n=3 Participants
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.
|
Hollow Tube Conduit
n=3 Participants
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)
|
|---|---|---|
|
12- Month DASH (Sports/Performing Arts Module)
modified intent-to-treat
|
8.33 score on a scale
Standard Error 8.33
|
18.77 score on a scale
Standard Error 9.56
|
|
12- Month DASH (Sports/Performing Arts Module)
per protocol
|
8.33 score on a scale
Standard Error 8.33
|
18.77 score on a scale
Standard Error 9.56
|
SECONDARY outcome
Timeframe: 12-monthsPopulation: 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.
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".
Outcome measures
| Measure |
Avance Nerve Graft
n=5 Participants
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.
|
Hollow Tube Conduit
n=6 Participants
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)
|
|---|---|---|
|
Pain at 12-months
modified intent to treat
|
0.54 units on a scale
Standard Error 0.28
|
0.92 units on a scale
Standard Error 0.41
|
|
Pain at 12-months
per protocol
|
0.54 units on a scale
Standard Error 0.28
|
0.92 units on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: 12-monthPopulation: 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.
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").
Outcome measures
| Measure |
Avance Nerve Graft
n=6 Participants
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.
|
Hollow Tube Conduit
n=7 Participants
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)
|
|---|---|---|
|
Thermal Discretion at 12-months
Modified Intent to Treat · Yes (Thermal Discretion)
|
6 Participants
|
7 Participants
|
|
Thermal Discretion at 12-months
Modified Intent to Treat · No (Thermal Discretion)
|
0 Participants
|
0 Participants
|
|
Thermal Discretion at 12-months
Per Protocol · Yes (Thermal Discretion)
|
6 Participants
|
7 Participants
|
|
Thermal Discretion at 12-months
Per Protocol · No (Thermal Discretion)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Avance Nerve Graft
n=6 Participants
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.
|
Hollow Tube Conduit
n=9 Participants
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)
|
|---|---|---|
|
Protective Sensation Present at 12-months
modified intent to treat · Protective Sensation Present
|
5 Participants
|
4 Participants
|
|
Protective Sensation Present at 12-months
modified intent to treat · Protective Sensation Diminished
|
1 Participants
|
3 Participants
|
|
Protective Sensation Present at 12-months
modified intent to treat · Protective Sensation Absent
|
0 Participants
|
2 Participants
|
|
Protective Sensation Present at 12-months
per protocol · Protective Sensation Present
|
5 Participants
|
4 Participants
|
|
Protective Sensation Present at 12-months
per protocol · Protective Sensation Diminished
|
1 Participants
|
3 Participants
|
|
Protective Sensation Present at 12-months
per protocol · Protective Sensation Absent
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Avance Nerve Graft
n=6 Participants
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.
|
Hollow Tube Conduit
n=7 Participants
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)
|
|---|---|---|
|
Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
modified intent to treat · S1
|
0 Participants
|
2 Participants
|
|
Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
modified intent to treat · S2
|
0 Participants
|
0 Participants
|
|
Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
modified intent to treat · S3
|
2 Participants
|
0 Participants
|
|
Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
modified intent to treat · S3+
|
1 Participants
|
0 Participants
|
|
Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
modified intent to treat · S4
|
3 Participants
|
5 Participants
|
|
Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
per protocol · S1
|
0 Participants
|
2 Participants
|
|
Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
per protocol · S2
|
0 Participants
|
0 Participants
|
|
Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
per protocol · S3
|
2 Participants
|
0 Participants
|
|
Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
per protocol · S3+
|
1 Participants
|
0 Participants
|
|
Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
per protocol · S4
|
3 Participants
|
5 Participants
|
Adverse Events
Avance Nerve Graft
Hollow Tube Conduit
Serious adverse events
| Measure |
Avance Nerve Graft
n=14 participants at risk
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.
|
Hollow Tube Conduit
n=9 participants at risk
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)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteomyleitis
|
0.00%
0/14 • Adverse Events were collected from the time of randomization through 1 year.
|
11.1%
1/9 • Number of events 1 • Adverse Events were collected from the time of randomization through 1 year.
|
|
Infections and infestations
Infection
|
7.1%
1/14 • Number of events 1 • Adverse Events were collected from the time of randomization through 1 year.
|
0.00%
0/9 • Adverse Events were collected from the time of randomization through 1 year.
|
Other adverse events
| Measure |
Avance Nerve Graft
n=14 participants at risk
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.
|
Hollow Tube Conduit
n=9 participants at risk
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)
|
|---|---|---|
|
Nervous system disorders
Occasional Pain
|
0.00%
0/14 • Adverse Events were collected from the time of randomization through 1 year.
|
11.1%
1/9 • Number of events 1 • Adverse Events were collected from the time of randomization through 1 year.
|
Additional Information
Vice President, Clinical and Translational Sciences
AxoGen, Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place