CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment

Dupuytren's Contracture Clinical Trial

— CORRECT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715467
• Other study ID #: AUX-CC-901
• Status: Completed
• Phase: N/A
• First received: October 25, 2012
• Last updated: June 12, 2015
• Start date: September 2012
• Est. completion date: October 2014

Study information

• Verified date: June 2015
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. In addition, this study will provide additional health economics and utilization data.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients who decide not to pursue correction of the Dupuytren's contracture.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren's Contracture

Locations

Country	Name	City	State
United States	Comprehensive Hand Surgery PC	Brooklyn	New York
United States	Raven Orthopaedics, Inc.	Burbank	California
United States	Charlottesville Orthopaedic Center, PLC	Charlottesville	Virginia
United States	The Plastic Surgery Group	Chattanooga	Tennessee
United States	Physicians for the Hand	Coral Gables	Florida
United States	Hand Surgery Associates	Denver	Colorado
United States	Central Jersey Hand Surgery	Eatontown	New Jersey
United States	Core Orthopaedic Medical Center	Encinitas	California
United States	Steadman Hawkins Clinic of the Carolinas	Greenville	South Carolina
United States	Indiana Hand to Shoulder Center	Indianapolis	Indiana
United States	Torrey Pines Orthopaedic Medical Group	La Jolla	California
United States	Florida Medical Research Institute	Lady Lake	Florida
United States	The Minimally Invasive Hand Institute	Las Vegas	Nevada
United States	Bluegrass Orthopaedics and Hand Care Research	Lexington	Kentucky
United States	OrthoGeorgia	Macon	Georgia
United States	OrthoMemphis	Memphis	Tennessee
United States	Brigid Freyne, MD, Inc.	Murrieta	California
United States	Vanderbilt Orthopaedic Institute	Nashville	Tennessee
United States	Vanderbilt Orthopaedic Institute	Nashville	Tennessee
United States	Beth Isreal Medical Center	New York	New York
United States	Hospital for Special Surgery	New York	New York
United States	Faith Regional Health Services	Norfolk	Nebraska
United States	Rockford Orthopedic Associates, LTD	Rockford	Illinois
United States	Core Orthopedics	Sioux Falls	South Dakota
United States	Cleveland Clinic Florida	Weston	Florida
United States	The Hand Center	Wichita	Kansas
United States	Wake Forest University Health Sciences	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	4 years	Yes