CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment
CORRECT
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.
1 other identifier
observational
162
1 country
27
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2012
Typical duration for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 25, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedJune 16, 2015
June 1, 2015
2.1 years
October 25, 2012
June 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4 years
Secondary Outcomes (1)
Examine safety, effectiveness and association between treatments and selected healthcare utilization and patient report outcomes.
4 years
Eligibility Criteria
Community based sample
You may qualify if:
- Women or men 18 years of age or older
- Patients with a Dupuytren's contracture of at least a single joint and a desire for correction
- Patients who are able to read and understand English
- Patients who are capable of understanding and cooperating with the requirements of the study
- Patients who are willing and able to respond to the posttreatment assessments via telephone or internet
- 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.
You may not qualify if:
- Patients who decide not to pursue correction of the Dupuytren's contracture.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Raven Orthopaedics, Inc.
Burbank, California, 91505, United States
Core Orthopaedic Medical Center
Encinitas, California, 92024, United States
Torrey Pines Orthopaedic Medical Group
La Jolla, California, 92037, United States
Brigid Freyne, MD, Inc.
Murrieta, California, 92563, United States
Hand Surgery Associates
Denver, Colorado, 80210, United States
Physicians for the Hand
Coral Gables, Florida, 33146, United States
Florida Medical Research Institute
Lady Lake, Florida, 32159, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
OrthoGeorgia
Macon, Georgia, 31201, United States
Rockford Orthopedic Associates, LTD
Rockford, Illinois, 61107, United States
Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260, United States
The Hand Center
Wichita, Kansas, 67208, United States
Bluegrass Orthopaedics and Hand Care Research
Lexington, Kentucky, 40509, United States
Faith Regional Health Services
Norfolk, Nebraska, 68701, United States
The Minimally Invasive Hand Institute
Las Vegas, Nevada, 89147, United States
Central Jersey Hand Surgery
Eatontown, New Jersey, 07724, United States
Comprehensive Hand Surgery PC
Brooklyn, New York, 11219, United States
Beth Isreal Medical Center
New York, New York, 10003, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27106, United States
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, 29605, United States
Core Orthopedics
Sioux Falls, South Dakota, 57103, United States
The Plastic Surgery Group
Chattanooga, Tennessee, 37403, United States
OrthoMemphis
Memphis, Tennessee, 38120, United States
Vanderbilt Orthopaedic Institute
Nashville, Tennessee, 37232, United States
Vanderbilt Orthopaedic Institute
Nashville, Tennessee, 37240, United States
Charlottesville Orthopaedic Center, PLC
Charlottesville, Virginia, 22911, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Urdaneta Veronica, MD
Endo Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2012
First Posted
October 29, 2012
Study Start
September 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
June 16, 2015
Record last verified: 2015-06