Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT01809002
Status:
COMPLETED
Last Update Posted:
2023-07-12
First Post:
2013-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarnold@axogeninc.com', 'phone': '770-833-2570', 'title': 'Stacy Arnold, VP of Clinical Research', 'organization': 'Axogen'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'It is important to refer to the population being analyzed and the analysis methodology, as certain analyses include a repeated measures mixed modeling approach to address missing or incomplete data, while other analyses were conducted with as reported data. This resulted in certain populations containing extrapolated data for missing or incomplete data points and others excluded those subjects from the analysis.'}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Processed Nerve Allograft', 'description': 'Processed Nerve Allograft\n\nProcessed Nerve Allograft (human)', 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 12, 'seriousNumAtRisk': 112, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Collagen Nerve Cuff', 'description': 'Collagen Nerve Cuff: Bovine collagen based nerve cuff', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 15, 'seriousNumAtRisk': 108, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Implant site hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Sickle cell anaemia with crisis - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Staphylococcal bacteraemia - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retroperitonial haemorrhage - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Embolic stroke - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytosis - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malignant hypertension - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19 - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Localized infection - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Overdose - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Completed suicide - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound dehiscence', 'notes': 'Anticipated risk of a surgical procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tendon rupture - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis - Unrelated', 'notes': 'Determined to be Unrelated to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Static Two-Point Discrimination (Pre-defined Mixed Modeling Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Processed Nerve Allograft (PNA)', 'description': 'Commercially available Processed Nerve Allograft for repair of nerve gap'}, {'id': 'OG001', 'title': 'Collagen Nerve Cuff', 'description': 'Commercially available collagen nerve cuff for repair of nerve gap'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '8.116', 'upperLimit': '10.041'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '8.403', 'upperLimit': '10.240'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.2', 'ciLowerLimit': '-1.087', 'ciUpperLimit': '1.574', 'groupDescription': 'The analysis was performed using a pre-defined standard statistical analysis with a non-response/failure assigned a worst-case scenario value of 16mm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The primary endpoint tested non-inferiority as compared to collagen nerve cuff and superior to no treatment. Non-inferiority is defined as the lower limit of the 95% CI about the difference of \\> -2 and the upper limit of the 95% CI for s2PD for Avance of \\< 13 in ITT table.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 12', 'description': "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.", 'unitOfMeasure': 'Millimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Static Two-Point Discrimination (Data As-reported)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Processed Nerve Allograft (PNA) (Gap 5-14mm)', 'description': 'Commercially available Processed Nerve Allograft for repair of nerve gap'}, {'id': 'OG001', 'title': 'Collagen Nerve Cuff (Gap 5-14mm)', 'description': 'Commercially available collagen nerve cuff for repair of nerve gap'}, {'id': 'OG002', 'title': 'Processed Nerve Allograft (PNA) (Gap 15-25mm)', 'description': 'Commercially available Processed Nerve Allograft for repair of nerve gap'}, {'id': 'OG003', 'title': 'Collagen Nerve Cuff (Gap 15-25mm)', 'description': 'Commercially available collagen nerve cuff for repair of nerve gap'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '14'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '15'}, {'value': '6.1', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '14'}, {'value': '7.5', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '14'}]}]}], 'analyses': [{'pValue': '0.035', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.365', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to Month 12', 'description': "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.", 'unitOfMeasure': 'Millimeters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', 'title': 'Response Rate for Recovery of s2PD at Month 12 (Data As-Reported)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Processed Nerve Allograft (PNA)', 'description': 'Commercially available Processed Nerve Allograft for repair of nerve gap'}, {'id': 'OG001', 'title': 'Collagen Nerve Cuff', 'description': 'Commercially available collagen nerve cuff for repair of nerve gap'}], 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000'}, {'value': '77.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.915', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The number and percentage of all treated subjects who recovered s2PD in the target repair at Month 12 (i.e., s2PD of 2 - 15 mm) were summarized by repair type. Differences between the repair types were assessed using a logistic regression analysis.', 'groupDescription': 'Responders were defined as subjects achieving s2PD of 2-15 mm on the target nerve repair.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': "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.", 'unitOfMeasure': '% of subjects with recovery of s2PD', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percent Recovery to Pre-Injury Baseline (Contralateral Control Value) s2PD at Month 12 (Pre-defined Modeling Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Processed Nerve Allograft (PNA)', 'description': 'Commercially available Processed Nerve Allograft for repair of nerve gap'}, {'id': 'OG001', 'title': 'Collagen Nerve Cuff', 'description': 'Commercially available collagen nerve cuff for repair of nerve gap'}], 'classes': [{'categories': [{'measurements': [{'value': '54.46', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '200.0'}, {'value': '51.67', 'groupId': 'OG001', 'lowerLimit': '18.8', 'upperLimit': '150.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.84', 'ciLowerLimit': '-11.6316', 'ciUpperLimit': '5.9541', 'pValueComment': 'Pre-injury baseline was defined as s2PD in the contralateral digit associated with the target digit.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'This analysis was assessed in the ITT population, at Month 12 using the LS Mean differences from a repeated measures ANCOVA model.'}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': "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.", 'unitOfMeasure': '% recovery', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Time to Recovery of s2PD (Data As-reported)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Processed Nerve Allograft (PNA)', 'description': 'Commercially available Processed Nerve Allograft for repair of nerve gap'}, {'id': 'OG001', 'title': 'Collagen Nerve Cuff', 'description': 'Commercially available collagen nerve cuff for repair of nerve gap'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '15'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '15'}]}]}], 'analyses': [{'pValue': '0.792', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Kaplan-Meier median and 95% CI', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Differences between the repair types were assessed with a KM log-rank test that was appropriate for the handing of interval-censored data.'}], 'paramType': 'MEAN', '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)', 'description': "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.", 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Medical Research Council (MRC) Classification for Sensory Function Scores at Month 12 (Data As-reported)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Processed Nerve Allograft (PNA)', 'description': 'Commercially available Processed Nerve Allograft for repair of nerve gap'}, {'id': 'OG001', 'title': 'Collagen Nerve Cuff', 'description': 'Commercially available collagen nerve cuff for repair of nerve gap'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '0.526', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'This analysis was completed to detect a distribution shift of the MRCC score between repairs with PNA and repairs with nerve cuff at Month 12.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Month 12', 'description': '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.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change in Pain Visual Analogue Scale (VAS) Scores at Month 12 (Pre-defined Modeling Approach)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Processed Nerve Allograft (PNA)', 'description': 'Commercially available Processed Nerve Allograft for repair of nerve gap'}, {'id': 'OG001', 'title': 'Collagen Nerve Cuff', 'description': 'Commercially available collagen nerve cuff for repair of nerve gap'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.09', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '50.0'}, {'value': '-24.94', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '50.0'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-24.09', 'groupDescription': 'This analysis compares the change in 12 Month Pain VAS scores from Baseline. Missing or incomplete data was extrapolated using a pre-defined repeated measures modeling approach for calculations in this analysis.\n\nThis analysis assesses each treatment group for clinically meaningful improvement in VAS from Baseline assuming a Meaningful Clinically Important Difference delta of 20 points (mm).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': '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.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Persistent and Unresolved Pain (Data As-reported)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Processed Nerve Allograft (PNA)', 'description': 'Commercially available Processed Nerve Allograft for repair of nerve gap'}, {'id': 'OG001', 'title': 'Collagen Nerve Cuff', 'description': 'Commercially available collagen nerve cuff for repair of nerve gap'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Operative Day+1, Month 1, Month 3, Month 6, Month 9, Month 12', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No interpolated data or modeling was used for this analysis. This is the Safety population which includes all subjects that received a nerve repair.'}, {'type': 'POST_HOC', 'title': 'Analysis of Time to Recovery of Sensibility Measured By Static Two-Point Discrimination (Gaps 15-25 mm) (Data As-reported)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Processed Nerve Allograft (PNA)', 'description': 'Commercially available Processed Nerve Allograft for repair of nerve gap (nerve gaps 15-25 mm)'}, {'id': 'OG001', 'title': 'Collagen Nerve Cuff', 'description': 'Commercially available collagen nerve cuff for repair of nerve gap (nerve gaps 15-25 mm)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '12'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at Month 1, Month 3, Month 6, Month 9, Month 12', 'description': "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.", 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'POST_HOC', 'title': 'Analysis of Time to Recovery of Sensibility Measured By Static Two-Point Discrimination by Nerve Gap Length (Gap Length 11-25mm) (Data As-reported)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Processed Nerve Allograft (PNA)', 'description': 'Commercially available Processed Nerve Allograft for repair of nerve gap'}, {'id': 'OG001', 'title': 'Collagen Nerve Cuff', 'description': 'Commercially available collagen nerve cuff for repair of nerve gap'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '12'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '12'}]}]}], 'analyses': [{'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'This analysis was completed utilizing a one-sided Wilcoxon Rank Sum test.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at Month 3, Month 6, Month 9, and Month 12', 'description': "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.", 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'POST_HOC', 'title': 'Analysis of Recovered Sensibility Measured By Static Two-Point Discrimination by Nerve Gap Length (Gap Length 13-25mm) (Data As-reported)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Processed Nerve Allograft (PNA)', 'description': 'Commercially available Processed Nerve Allograft for repair of nerve gap'}, {'id': 'OG001', 'title': 'Collagen Nerve Cuff', 'description': 'Commercially available collagen nerve cuff for repair of nerve gap'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '14'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '14'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-sided Wilcoxon Rank Sum test was utilized for this analysis.'}], 'paramType': 'MEAN', 'timeFrame': 'Up to Month 12', 'description': "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.", 'unitOfMeasure': 'mm of s2PD', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "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."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Processed Nerve Allograft', 'description': 'Processed Nerve Allograft\n\nProcessed Nerve Allograft (human)'}, {'id': 'FG001', 'title': 'Collagen Nerve Cuff', 'description': 'Collagen Nerve Cuff: Bovine collagen based nerve cuff'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Processed Nerve Allograft', 'description': 'Processed Nerve Allograft\n\nProcessed Nerve Allograft (human)'}, {'id': 'BG001', 'title': 'Collagen Nerve Cuff', 'description': 'Collagen Nerve Cuff: Bovine collagen based nerve cuff'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.2', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '39.8', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '38.5', 'spread': '13.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'description': 'All subjects were randomized.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All subjects were randomized.', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All subjects were randomized.', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All subjects were randomized.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'All subjects were randomized.', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-12', 'size': 4819400, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-06T15:03', 'hasProtocol': True}, {'date': '2022-03-04', 'size': 2409085, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-06T15:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-05', 'studyFirstSubmitDate': '2013-03-04', 'resultsFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2013-03-08', 'lastUpdatePostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-05', 'studyFirstPostDateStruct': {'date': '2013-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Persistent and Unresolved Pain (Data As-reported)', 'timeFrame': 'Operative Day+1, Month 1, Month 3, Month 6, Month 9, Month 12', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Static Two-Point Discrimination (Pre-defined Mixed Modeling Approach)', 'timeFrame': 'Month 12', 'description': "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."}, {'measure': 'Static Two-Point Discrimination (Data As-reported)', 'timeFrame': 'Up to Month 12', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Response Rate for Recovery of s2PD at Month 12 (Data As-Reported)', 'timeFrame': 'Month 12', 'description': "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."}, {'measure': 'Percent Recovery to Pre-Injury Baseline (Contralateral Control Value) s2PD at Month 12 (Pre-defined Modeling Approach)', 'timeFrame': 'Month 12', 'description': "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."}, {'measure': 'Time to Recovery of s2PD (Data As-reported)', '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)', 'description': "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."}, {'measure': 'Medical Research Council (MRC) Classification for Sensory Function Scores at Month 12 (Data As-reported)', 'timeFrame': 'Month 12', 'description': '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.'}, {'measure': 'Change in Pain Visual Analogue Scale (VAS) Scores at Month 12 (Pre-defined Modeling Approach)', 'timeFrame': 'Month 12', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Nerve Discontinuities']}, 'descriptionModule': {'briefSummary': 'Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and functional outcomes for the repair of nerve injuries in the hand.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Peripheral Nerve Injury\n\nExclusion Criteria:\n\n* Peripheral Neuropathy\n* Allergic to Bovine products such as Bovine Collagen Nerve Cuff'}, 'identificationModule': {'nctId': 'NCT01809002', 'acronym': 'RECON', 'briefTitle': 'Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'Axogen Corporation'}, 'officialTitle': 'A Multicenter, Prospective, Randomized, Subject and Evaluator Blinded Comparative Study of Nerve Cuffs and Avance® Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities', 'orgStudyIdInfo': {'id': 'ANG-CP-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Processed Nerve Allograft', 'description': 'Processed Nerve Allograft', 'interventionNames': ['Biological: Processed Nerve Allograft (human)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Collagen Nerve Cuff', 'interventionNames': ['Device: Collagen Nerve Cuff']}], 'interventions': [{'name': 'Processed Nerve Allograft (human)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Processed Nerve Allograft']}, {'name': 'Collagen Nerve Cuff', 'type': 'DEVICE', 'description': 'Bovine collagen based nerve cuff', 'armGroupLabels': ['Collagen Nerve Cuff']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University California, Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33146', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Orthopaedic Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Hand to Shoulder Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Curtis National Hand Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin Healthcare', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Hand Surgery Specialists of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '14627', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '16801', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Universtiy', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Univeristy of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23228', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '25701', 'city': 'Huntington', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Marshall Orthopaedics', 'geoPoint': {'lat': 38.41925, 'lon': -82.44515}}], 'overallOfficials': [{'name': 'Jonathan E Isaacs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University Medical Center'}, {'name': 'L. Scott Levin, MD FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Axogen Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}