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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01715467
Other study ID # AUX-CC-901
Secondary ID
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


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
See also
  Status Clinical Trial Phase
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Completed NCT01407068 - Administration of Two Injections for Multiple Dupuytren's Contractures Phase 3
Completed NCT00528931 - A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture Phase 1
Completed NCT00565019 - Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture Phase 3
Completed NCT01588353 - Collagenase Option for Reduction of Dupuytren's Contracture in Japan Phase 3
Completed NCT00468949 - Health-Related Quality of Life in Patients With Dupuytren's Disease Phase 1
Completed NCT01444729 - Post Approval Commitment Study N/A
Terminated NCT05877066 - Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture
Completed NCT01265420 - Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb Phase 4
Completed NCT01229436 - Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex) Phase 3
Completed NCT00931567 - Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing Phase 2/Phase 3
Completed NCT00528606 - AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture Phase 3
Completed NCT00004409 - Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease Phase 2
Completed NCT00014742 - Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease Phase 3