Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-05 @ 5:42 PM
Study NCT ID:
NCT01715467
Status:
COMPLETED
Last Update Posted:
2015-06-16
First Post:
2012-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004387', 'term': 'Dupuytren Contracture'}, {'id': 'D003286', 'term': 'Contracture'}], 'ancestors': [{'id': 'D005350', 'term': 'Fibroma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-12', 'studyFirstSubmitDate': '2012-10-25', 'studyFirstSubmitQcDate': '2012-10-25', 'lastUpdatePostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The primary objective is to collect real-world data regarding patient reported outcomes of the 3 primary treatment modalities in patients with Dupuytren's contracture.", 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'Examine safety, effectiveness and association between treatments and selected healthcare utilization and patient report outcomes.', 'timeFrame': '4 years', 'description': "The secondary objectives are as follows:\n\n* Examine the safety trends of various treatment options in patients with Dupuytren's contracture\n* Examine the effectiveness trends of various treatment options, specifically evaluating long term contracture recurrence\n* Examine the association between various treatment regimens and healthcare resource utilization\n* Examine the association between various treatments and patient-reported outcomes (PROs) such as disease burden, ADLs, hand functionality, work performance, time to return to work, treatment satisfaction, and patient preference"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dupuytren', 'Contracture', 'Auxilium', 'XIAFLEX'], 'conditions': ["Dupuytren's Contracture"]}, 'descriptionModule': {'briefSummary': "This observational study will prospectively collect data on treatment options, patient/investigator satisfaction, requirement for retreatment or additional treatment, and long-term outcomes of 3 treatment modalities(XIAFLEX, fasciectomy, or fasciotomy/needle aponeurotomy) in patients with Dupuytren's contracture. In addition, this study will provide additional health economics and utilization data.", 'detailedDescription': "This is a prospective, multi-center, observational study. Patients will be recruited based on the usual care presentation at each investigative site, as regular practice would dictate. Consecutive patients deemed eligible for the study by their physician will be invited to participate during their usual care visit. Enrolled patients will receive evaluations and treatment for Dupuytren's contracture according to the standard of care and clinical practice at each study site. No study-specific visits will be required as part of the study. Treatment and Follow-up Visits will be determined by the treating physician. Treatments received for Dupuytren's contracture will be recorded (ie, XIAFLEX, fasciectomy, or fasciotomy/needle aponeurotomy), including initial treatment and any subsequent therapy. The full prescribing information and medication guide for XIAFLEX is provided in this protocol as reference (Appendix B). Patient data (including treatment outcomes, joint contracture measured by the treating physician, and evidence of recurrence) and health care resource utilization data will be drawn from the patients' medical records, examination, and patient interviews. These data will be recorded via a web-based electronic data collection (EDC) system.\n\nPROs will be collected by self-completed questionnaires given to each patient via web-based data collection or telephone interviews. The site will follow up with the patient according to usual practice. Information from the patient's visit may include goniometry and the physician's assessment of treatment outcome and healthcare utilization. Patients will be considered enrolled in the study for a maximum of 4 years post-enrollment or until death, withdrawal of consent, loss to follow-up, or study closure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community based sample', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women or men 18 years of age or older\n* Patients with a Dupuytren's contracture of at least a single joint and a desire for correction\n* Patients who are able to read and understand English\n* Patients who are capable of understanding and cooperating with the requirements of the study\n* Patients who are willing and able to respond to the posttreatment assessments via telephone or internet\n* Patients must provide written informed consent, indicating that they understand the purpose of and requirements of the study and are willing to participate in the study.\n\nExclusion Criteria:\n\n* Patients who decide not to pursue correction of the Dupuytren's contracture."}, 'identificationModule': {'nctId': 'NCT01715467', 'acronym': 'CORRECT', 'briefTitle': "CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment", 'organization': {'class': 'INDUSTRY', 'fullName': 'Endo Pharmaceuticals'}, 'officialTitle': "Community Registry Study Evaluating Dupuytren's Contracture Treatment. A Prospective, Observational, Longitudinal, Multicenter Study of the Treatment Patterns and Outcomes in Patients With Dupuytren's Contracture.", 'orgStudyIdInfo': {'id': 'AUX-CC-901'}}, 'contactsLocationsModule': {'locations': [{'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Raven Orthopaedics, Inc.', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Core Orthopaedic Medical Center', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Torrey Pines Orthopaedic Medical Group', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92563', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'Brigid Freyne, MD, Inc.', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Hand Surgery Associates', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Physicians for the Hand', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32159', 'city': 'Lady Lake', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Medical Research Institute', 'geoPoint': {'lat': 28.91749, 'lon': -81.92286}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '31201', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'OrthoGeorgia', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '61107', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rockford Orthopedic Associates, LTD', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Hand to Shoulder Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '67208', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'The Hand Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Bluegrass Orthopaedics and Hand Care Research', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '68701', 'city': 'Norfolk', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Faith Regional Health Services', 'geoPoint': {'lat': 42.02834, 'lon': -97.417}}, {'zip': '89147', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'The Minimally Invasive Hand Institute', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07724', 'city': 'Eatontown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Central Jersey Hand Surgery', 'geoPoint': {'lat': 40.29622, 'lon': -74.05097}}, {'zip': '11219', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Comprehensive Hand Surgery PC', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Isreal Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27106', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Steadman Hawkins Clinic of the Carolinas', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '57103', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Core Orthopedics', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Plastic Surgery Group', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'OrthoMemphis', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Orthopaedic Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37240', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Orthopaedic Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '22911', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Charlottesville Orthopaedic Center, PLC', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Urdaneta Veronica, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Endo Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}