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Completed

NCT Number: NCT01715467

CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Raven Orthopaedics, Inc., Burbank, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

    Time frame: 4 years

Secondary outcomes

  1. Examine safety, effectiveness and association between treatments and selected healthcare utilization and patient report outcomes.

    Time frame: 4 years

    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

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study 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.

Acronym: CORRECT

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 29, 2012
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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