Dupuytren's ContractureCORRECTNCT01715467
CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment
An observational study of Dupuytren's Contracture, run by Endo USA Inc., a Keenova Therapeutics Company at 27 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren's Contracture
- How many people
- 162 participants
- Where
- 27 sitesUnited States
- Study dates
- Sep 2012to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community based sample
Who may be able to join
- 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.
Who cannot join
- Patients who decide not to pursue correction of the Dupuytren's contracture.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Comprehensive Hand Surgery PC
Brooklyn, New York, 11219
Raven Orthopaedics, Inc.
Burbank, California, 91505
Charlottesville Orthopaedic Center, PLC
Charlottesville, Virginia, 22911
The Plastic Surgery Group
Chattanooga, Tennessee, 37403
Physicians for the Hand
Coral Gables, Florida, 33146
Hand Surgery Associates
Denver, Colorado, 80210
Central Jersey Hand Surgery
Eatontown, New Jersey, 07724
Core Orthopaedic Medical Center
Encinitas, California, 92024
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, 29605
Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
Torrey Pines Orthopaedic Medical Group
La Jolla, California, 92037
Florida Medical Research Institute
Lady Lake, Florida, 32159
The Minimally Invasive Hand Institute
Las Vegas, Nevada, 89147
Bluegrass Orthopaedics and Hand Care Research
Lexington, Kentucky, 40509
OrthoGeorgia
Macon, Georgia, 31201
OrthoMemphis
Memphis, Tennessee, 38120
Brigid Freyne, MD, Inc.
Murrieta, California, 92563
Vanderbilt Orthopaedic Institute
Nashville, Tennessee, 37232
Vanderbilt Orthopaedic Institute
Nashville, Tennessee, 37240
Beth Isreal Medical Center
New York, New York, 10003
Hospital for Special Surgery
New York, New York, 10021
Faith Regional Health Services
Norfolk, Nebraska, 68701
Rockford Orthopedic Associates, LTD
Rockford, Illinois, 61107
Core Orthopedics
Sioux Falls, South Dakota, 57103
Cleveland Clinic Florida
Weston, Florida, 33331
The Hand Center
Wichita, Kansas, 67208
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27106
About this study
Official title: 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.
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.
Read the detailed description
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.
PROs 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.
- Conditions
- Dupuytren's Contracture
- Keywords
- Dupuytren, Contracture, Auxilium, XIAFLEX
- Medical subject headings
- Dupuytren Contracture, Contracture
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (1)
Examine safety, effectiveness and association between treatments and selected healthcare utilization and patient report outcomes.
The secondary objectives are as follows:
- Examine the safety trends of various treatment options in patients with Dupuytren's contracture
- Examine the effectiveness trends of various treatment options, specifically evaluating long term contracture recurrence
- Examine the association between various treatment regimens and healthcare resource utilization
- 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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren's ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Urdaneta Veronica, MD, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715467
- Sponsor's protocol ID
- AUX-CC-901
- Acronym
- CORRECT
- Status last verified
- Jun 2015
- First submitted
- 25 Oct 2012
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01715467
- Acronym / sponsor ID
- CORRECT / AUX-CC-901
- Conditions
- Dupuytren's Contracture
- Keywords
- Dupuytren, Contracture, Auxilium, XIAFLEX
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
PROs 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community based sample
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who decide not to pursue correction of the Dupuytren's contracture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 4 years
1 secondary outcome
Examine safety, effectiveness and association between treatments and selected healthcare utilization and patient report outcomes.
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urdaneta Veronica, MD study director
Endo USA Inc., a Keenova Therapeutics Company
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dupuytren's Contracture, run by Endo USA Inc., a Keenova Therapeutics Company at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.