Trial Outcomes & Findings for Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair (NCT NCT01809002)
NCT ID: NCT01809002
Last Updated: 2023-07-12
Results Overview
Static two-point discrimination (s2PD) is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were imputed as the worst case scenario value possible (16mm). Missing or incomplete data was extrapolated using a pre-defined repeated measures mixed modeling approach for calculations in this analysis. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations.
COMPLETED
PHASE3
220 participants
Month 12
2023-07-12
Participant Flow
Participant milestones
| Measure |
Processed Nerve Allograft
Processed Nerve Allograft
Processed Nerve Allograft (human)
|
Collagen Nerve Cuff
Collagen Nerve Cuff: Bovine collagen based nerve cuff
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
108
|
|
Overall Study
COMPLETED
|
91
|
92
|
|
Overall Study
NOT COMPLETED
|
21
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
Baseline characteristics by cohort
| Measure |
Processed Nerve Allograft
n=112 Participants
Processed Nerve Allograft
Processed Nerve Allograft (human)
|
Collagen Nerve Cuff
n=108 Participants
Collagen Nerve Cuff: Bovine collagen based nerve cuff
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.2 Years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
39.8 Years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
38.5 Years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
112 participants
n=5 Participants
|
108 participants
n=7 Participants
|
220 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: This is the Per Protocol population which includes all patients in baseline population who have completed a minimum of 6 months follow-up and have no major protocol violations. The analysis was performed using a pre-defined statistical analysis with a non-response/failure assigned a worst-case scenario value of 16mm.
Static two-point discrimination (s2PD) is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were imputed as the worst case scenario value possible (16mm). Missing or incomplete data was extrapolated using a pre-defined repeated measures mixed modeling approach for calculations in this analysis. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations.
Outcome measures
| Measure |
Processed Nerve Allograft (PNA)
n=91 Participants
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff
n=92 Participants
Commercially available collagen nerve cuff for repair of nerve gap
|
Processed Nerve Allograft (PNA) (Gap 15-25mm)
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff (Gap 15-25mm)
Commercially available collagen nerve cuff for repair of nerve gap
|
|---|---|---|---|---|
|
Static Two-Point Discrimination (Pre-defined Mixed Modeling Approach)
|
9.1 Millimeters
Interval 8.116 to 10.041
|
9.3 Millimeters
Interval 8.403 to 10.24
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Month 12Population: No interpolated data or modeling was used for this analysis. Results by length of nerve gap (gap 5-14mm vs. gap 15-25mm). As there is no pre-defined numerical value for absent response/failure in as-reported data, 'absent' results were not included in this analysis. This is the Per Protocol population which includes all patients in baseline population who have completed a minimum of 6 months follow-up and have no major protocol violations.
s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were not imputed. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations. Data used for this analysis was from 6 months post-surgical follow-up to the date of each subject's latest completed s2PD assessment, whichever came last, assessed up to 12 months.
Outcome measures
| Measure |
Processed Nerve Allograft (PNA)
n=56 Participants
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff
n=59 Participants
Commercially available collagen nerve cuff for repair of nerve gap
|
Processed Nerve Allograft (PNA) (Gap 15-25mm)
n=35 Participants
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff (Gap 15-25mm)
n=33 Participants
Commercially available collagen nerve cuff for repair of nerve gap
|
|---|---|---|---|---|
|
Static Two-Point Discrimination (Data As-reported)
|
7.3 Millimeters
Interval 3.0 to 14.0
|
7.5 Millimeters
Interval 2.0 to 15.0
|
6.1 Millimeters
Interval 2.0 to 14.0
|
7.5 Millimeters
Interval 5.0 to 14.0
|
SECONDARY outcome
Timeframe: Month 12Population: This is the Intent To Treat population which includes all subjects that were randomized and have a reported value at Month 12. The analysis was performed using a pre-defined statistical analysis with a non-response/failure assigned a worst-case scenario value of 16mm. Missing or incomplete data was not included in this analysis of response rate.
This is the percentage of subjects who achieved sensibility as defined by s2PD 2mm-15mm at Month 12. s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were imputed as the worst case scenario value possible (16mm). This analysis was completed on the Intent-to-Treat population, defined as all subjects who were randomized.
Outcome measures
| Measure |
Processed Nerve Allograft (PNA)
n=71 Participants
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff
n=79 Participants
Commercially available collagen nerve cuff for repair of nerve gap
|
Processed Nerve Allograft (PNA) (Gap 15-25mm)
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff (Gap 15-25mm)
Commercially available collagen nerve cuff for repair of nerve gap
|
|---|---|---|---|---|
|
Response Rate for Recovery of s2PD at Month 12 (Data As-Reported)
|
77.5 % of subjects with recovery of s2PD
|
77.2 % of subjects with recovery of s2PD
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: This is the Intent To Treat population which includes all subjects that were randomized and have a reported value at Month 12. The analysis was performed using a pre-defined statistical analysis with a non-response/failure assigned a worst-case scenario value of 16mm. Missing or incomplete data was extrapolated using a pre-defined repeated mixed measures modeling approach for calculations in this analysis.
This is the ratio of sensibility at Month 12 relative to sensibility at baseline for which the contralateral control value at Month 12 was used, expressed as a percentage. Pre-injury baseline was defined as s2PD at Month 12 in the contralateral digit associated with the target digit. Percent recovery to Pre-Injury Baseline was defined as: change from Pre-Injury Baseline (Contralateral control value) divided by the Pre-Injury Baseline Value \*100. s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were imputed as the worst case scenario value possible (16mm). This analysis was completed on the Intent-to-Treat population, defined as all subjects who were randomized.
Outcome measures
| Measure |
Processed Nerve Allograft (PNA)
n=71 Participants
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff
n=79 Participants
Commercially available collagen nerve cuff for repair of nerve gap
|
Processed Nerve Allograft (PNA) (Gap 15-25mm)
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff (Gap 15-25mm)
Commercially available collagen nerve cuff for repair of nerve gap
|
|---|---|---|---|---|
|
Percent Recovery to Pre-Injury Baseline (Contralateral Control Value) s2PD at Month 12 (Pre-defined Modeling Approach)
|
54.46 % recovery
Interval 12.5 to 200.0
|
51.67 % recovery
Interval 18.8 to 150.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at Month 3, Month 6, Month 9, Month 12 (some patients were seen for their 12-month visit up to 15 calendar months post-op)Population: This is the Intent To Treat population which includes all subjects that were randomized. Any subject with a value of s2PD of absent was considered not recovered and was therefore not included in this analysis.
Time to recovery of s2PD was defined as the number of months from Operative day to the return of sensory function (defined as Medical Research Council sensory function score of S3+ or greater) at Month 3, Month 6, Month 9, or Month 12. s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm and 15mm. S4 is s2PD of 2-6mm and S3+ is s2PD of 7-15mm. Those without S3+ and absent values were considered not recovered. This is the Intent To Treat population which includes all subjects that were randomized. Any subject with a value of s2PD of absent was considered not recovered and was therefore not included in this analysis.
Outcome measures
| Measure |
Processed Nerve Allograft (PNA)
n=112 Participants
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff
n=108 Participants
Commercially available collagen nerve cuff for repair of nerve gap
|
Processed Nerve Allograft (PNA) (Gap 15-25mm)
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff (Gap 15-25mm)
Commercially available collagen nerve cuff for repair of nerve gap
|
|---|---|---|---|---|
|
Time to Recovery of s2PD (Data As-reported)
|
8.0 Months
Interval 3.0 to 15.0
|
7.8 Months
Interval 3.0 to 15.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: This is the Intent To Treat population which includes all subjects that were randomized and have a reported value at Month 12. In this analysis of Month 12 data, MRCC scores are assigned numeric values: S0=0, S1=1, S2=2, S3=3, S3+=4, S4=5.
MRC classification score is a functional recovery classification. For nerves with sensory targets, outcomes resulting from static two-point discrimination and Semmes-Weinstein Monofilament pressure threshold testing are used to determine the classification score. Sensibility testing for the target repair was performed by a blinded assessor using a standardized discriminator tool and Semmes-Weinstein monofilaments. Upper bound response for static two-point discrimination was 15mm. This is the Intent To Treat population which includes all subjects that were randomized and have a reported value at Month 12. Scale range: Minimum S0 = 0 (no sensibility), S1=1, S2=2, S3=3, S3+=4, maximum S4 = 5 (normative levels of sensibility). Higher values represented better outcomes.
Outcome measures
| Measure |
Processed Nerve Allograft (PNA)
n=71 Participants
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff
n=79 Participants
Commercially available collagen nerve cuff for repair of nerve gap
|
Processed Nerve Allograft (PNA) (Gap 15-25mm)
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff (Gap 15-25mm)
Commercially available collagen nerve cuff for repair of nerve gap
|
|---|---|---|---|---|
|
Medical Research Council (MRC) Classification for Sensory Function Scores at Month 12 (Data As-reported)
|
4.0 Score on a scale
Interval 0.0 to 5.0
|
4.0 Score on a scale
Interval 0.0 to 5.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: This is the Intent To Treat population which includes all subjects that were randomized. The analysis was performed using a standard statistical analysis on Month 12 data. The analysis compared Month 12 VAS to Baseline VAS within-group. No between-group analyses were conducted.
The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicated their 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 were 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". This is the Intent To Treat population which includes all subjects that were randomized. The analysis was performed using a standard statistical analysis on Month 12 data. Missing or incomplete data was extrapolated using a pre-defined repeated measures modeling approach for calculations in this analysis.
Outcome measures
| Measure |
Processed Nerve Allograft (PNA)
n=74 Participants
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff
n=80 Participants
Commercially available collagen nerve cuff for repair of nerve gap
|
Processed Nerve Allograft (PNA) (Gap 15-25mm)
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff (Gap 15-25mm)
Commercially available collagen nerve cuff for repair of nerve gap
|
|---|---|---|---|---|
|
Change in Pain Visual Analogue Scale (VAS) Scores at Month 12 (Pre-defined Modeling Approach)
|
-24.09 Units on a scale
Interval -100.0 to 50.0
|
-24.94 Units on a scale
Interval -100.0 to 50.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Operative Day+1, Month 1, Month 3, Month 6, Month 9, Month 12Population: No interpolated data or modeling was used for this analysis. This is the Safety population which includes all subjects that received a nerve repair.
No interpolated data or modeling was used for this analysis. This analysis was completed for Adverse Event (AE) criteria related to pain and hypersensitivity (Pain, Pain in Extremity, Hypersensitivity, Hypersensitivity at implant site, Neuroma, and derivations of these descriptors) beginning after Operative Day (Operative Day+1). Revision surgeries for Pain-Related conditions documented as Ongoing were also included. Recovered/Resolved AEs were not included in the analysis unless the resolution was surgical revision. Unrelated AEs were also not included in this analysis. This is the Safety population which includes all subjects that received a nerve repair.
Outcome measures
| Measure |
Processed Nerve Allograft (PNA)
n=112 Participants
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff
n=108 Participants
Commercially available collagen nerve cuff for repair of nerve gap
|
Processed Nerve Allograft (PNA) (Gap 15-25mm)
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff (Gap 15-25mm)
Commercially available collagen nerve cuff for repair of nerve gap
|
|---|---|---|---|---|
|
Number of Participants With Persistent and Unresolved Pain (Data As-reported)
|
2 Participants
|
9 Participants
|
—
|
—
|
POST_HOC outcome
Timeframe: Assessed at Month 1, Month 3, Month 6, Month 9, Month 12Population: No interpolated data or modeling was used for this analysis. This is the Per Protocol population which includes all subjects in baseline population who have completed a minimum of 6 months follow-up and have no major protocol violations. Results are a subset of the Per Protocol population by length of nerve gap for Month 1 to Month 12.
A post-hoc analysis was performed to determine the difference between treatment groups in the time from index surgery to the recovery of sensibility in the target nerve repair. s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm and 15mm. Time to Recovery of sensibility is defined as the month of the subject's visit where they achieved s2PD of 2-15 mm and maintained s2PD through their last visit. Missing or incomplete assessments were not imputed. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations.
Outcome measures
| Measure |
Processed Nerve Allograft (PNA)
n=35 Participants
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff
n=33 Participants
Commercially available collagen nerve cuff for repair of nerve gap
|
Processed Nerve Allograft (PNA) (Gap 15-25mm)
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff (Gap 15-25mm)
Commercially available collagen nerve cuff for repair of nerve gap
|
|---|---|---|---|---|
|
Analysis of Time to Recovery of Sensibility Measured By Static Two-Point Discrimination (Gaps 15-25 mm) (Data As-reported)
|
3.0 Months
Interval 1.0 to 9.0
|
5.6 Months
Interval 1.0 to 12.0
|
—
|
—
|
POST_HOC outcome
Timeframe: Assessed at Month 3, Month 6, Month 9, and Month 12Population: The failure to respond to stimulus was not recorded, thus only subjects with recovered sensibility are included in this data set. No interpolated data or modeling was used for this analysis. This is the Per Protocol population which includes all subjects in baseline population who have completed a minimum of 6 months follow-up and have no major protocol violations.
A post-hoc analysis was performed to determine the difference between treatment groups in the time from index surgery to the recovery of sensibility in the target nerve repair by gap length interval. Data were grouped by gap length, starting with 15-25 and incrementally including additional gap lengths (i.e. 14, 13, 12, 11, and 10) when statistical significance was observed between groups. s2PD is measured by blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm and 15mm. Time to Recovery of sensibility is defined as the month of the subject's visit where they achieved subject's achievement of s2PD of 2-15 mm and maintained s2PD through their last visit. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations.
Outcome measures
| Measure |
Processed Nerve Allograft (PNA)
n=57 Participants
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff
n=53 Participants
Commercially available collagen nerve cuff for repair of nerve gap
|
Processed Nerve Allograft (PNA) (Gap 15-25mm)
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff (Gap 15-25mm)
Commercially available collagen nerve cuff for repair of nerve gap
|
|---|---|---|---|---|
|
Analysis of Time to Recovery of Sensibility Measured By Static Two-Point Discrimination by Nerve Gap Length (Gap Length 11-25mm) (Data As-reported)
|
4.4 Months
Interval 3.0 to 12.0
|
5.4 Months
Interval 3.0 to 12.0
|
—
|
—
|
POST_HOC outcome
Timeframe: Up to Month 12Population: No interpolated data or modeling was used for this analysis. As there is no pre-defined numerical value for absent response/failure in the data as-reported, patients with a result of 'absent' were not included in this analysis. This is the Per Protocol population which includes all subjects in baseline population who have completed a minimum of 6 months follow-up and have no major protocol violations.
A post-hoc analysis was performed to determine the gap length (in mm) at which a statistically significant difference in the recovery of sensibility between treatment groups could be detected. Data were grouped by gap length, starting with 15-25 and incrementally including additional gap lengths (i.e. 14, 13 and 12) when statistical significance was observed between groups. s2PD is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm and 15mm. Patients with a result of 'absent' were not included in this analysis. This analysis was completed on the Per Protocol population, defined as subjects with at least 6 months follow-up and no major protocol violations. Data used for this analysis was from 6 months post-surgical follow-up to the date of each subject's latest completed s2PD assessment, whichever came last, assessed up to 12 months.
Outcome measures
| Measure |
Processed Nerve Allograft (PNA)
n=48 Participants
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff
n=43 Participants
Commercially available collagen nerve cuff for repair of nerve gap
|
Processed Nerve Allograft (PNA) (Gap 15-25mm)
Commercially available Processed Nerve Allograft for repair of nerve gap
|
Collagen Nerve Cuff (Gap 15-25mm)
Commercially available collagen nerve cuff for repair of nerve gap
|
|---|---|---|---|---|
|
Analysis of Recovered Sensibility Measured By Static Two-Point Discrimination by Nerve Gap Length (Gap Length 13-25mm) (Data As-reported)
|
6.2 mm of s2PD
Interval 2.0 to 14.0
|
7.6 mm of s2PD
Interval 4.0 to 14.0
|
—
|
—
|
Adverse Events
Processed Nerve Allograft
Collagen Nerve Cuff
Serious adverse events
| Measure |
Processed Nerve Allograft
n=112 participants at risk
Processed Nerve Allograft
Processed Nerve Allograft (human)
|
Collagen Nerve Cuff
n=108 participants at risk
Collagen Nerve Cuff: Bovine collagen based nerve cuff
|
|---|---|---|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis - Unrelated
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
|
Renal and urinary disorders
Acute kidney injury - Unrelated
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
|
Infections and infestations
Staphylococcal bacteraemia - Unrelated
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
|
Gastrointestinal disorders
Retroperitonial haemorrhage - Unrelated
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
|
Infections and infestations
Septic shock - Unrelated
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
|
Hepatobiliary disorders
Embolic stroke - Unrelated
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
|
Vascular disorders
Deep vein thrombosis - Unrelated
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure - Unrelated
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
|
Blood and lymphatic system disorders
Leukocytosis - Unrelated
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
|
Vascular disorders
Malignant hypertension - Unrelated
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
|
Infections and infestations
COVID-19 - Unrelated
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
|
Infections and infestations
Localized infection - Unrelated
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
|
Injury, poisoning and procedural complications
Overdose - Unrelated
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
|
Psychiatric disorders
Completed suicide - Unrelated
|
0.00%
0/112 • 12 months
|
0.93%
1/108 • 12 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
|
Injury, poisoning and procedural complications
Tendon rupture - Unrelated
|
0.00%
0/112 • 12 months
|
0.93%
1/108 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis - Unrelated
|
0.89%
1/112 • 12 months
|
0.00%
0/108 • 12 months
|
Other adverse events
| Measure |
Processed Nerve Allograft
n=112 participants at risk
Processed Nerve Allograft
Processed Nerve Allograft (human)
|
Collagen Nerve Cuff
n=108 participants at risk
Collagen Nerve Cuff: Bovine collagen based nerve cuff
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.7%
3/112 • 12 months
|
5.6%
6/108 • 12 months
|
|
General disorders
Implant site hypersensitivity
|
2.7%
3/112 • 12 months
|
4.6%
5/108 • 12 months
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
1.8%
2/112 • 12 months
|
3.7%
4/108 • 12 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.6%
4/112 • 12 months
|
0.00%
0/108 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of at least sixty days prior to submission for publication for sponsor to review and comment. The Sponsor may extend the embargo for an additional 60 days to allow for the filing of a patent application or taking such measures Sponsor deems appropriate to establish and preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER