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Dupuytren Contracture

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Percutaneous needle fasciotomy with corticosteroid injection

Percutaneous needle fasciotomy with saline injection

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Percutaneous needle fasciotomy

Corticosteroid injection

Saline injection

Laura H Matthiesen, MS, PhD-student

Jeppe Lange, MD, PhD

Laura H Matthiesen, PhD Student

Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.

Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture

Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial

Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline

Regionshospitalet Silkeborg

Medical Student, PhD Student

Symptoms and General Pathology

Recurrence

Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord

Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord

Collagenase clostridium histolyticum

Veronica Urdaneta, MD, MPPH

The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study.

Open-label, Phase 4 study in subjects who are currently participating in the long-term follow-up study (ie, AUX-CC-860) in the United States, Australia, or Europe and who have recurrence of contracture (ie, joint contracture increases by at least 20 degrees compared with the Day 30 value after the last injection in a Phase 3 Auxilium-sponsored study and a palpable cord present) in a joint that was effectively treated (ie, reduction in contracture to 5 degrees or less 30 days after the last injection) with AA4500 in a Phase 3 Auxilium-sponsored study.

Subjects who experience recurrence of contracture in one or more effectively treated joints may be enrolled in this retreatment study after the investigator determines subject eligibility and after informed consent has been obtained. The investigator will treat the cord affecting the recurrent joint with up to three injections. Only one recurrent joint will be treated in this study.

Retreatment of Recurrent Dupuytren's Contractures

Retreatment of Recurrent Contractures in Joints Effectively Treated With AA4500 (Collagenase Clostridium Histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-sponsored Phase 3 Study in the United States, Australia, and Europe

Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500

Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees

Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees

Physician global assessment of change (improvement) in subject's Dupuytren's contracture

Subject global assessment of overall treatment satisfaction

Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points.

Endo Pharmaceuticals

XIAFLEX/XIAPEX: up to three 0.58 mg injections

XIAFLEX/XIAPEX

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Australia

United Kingdom

Sweden

Region of Enrollment

Clinical Trial Coordinator

XIAFLEX/XIAPEX MP Joint

XIAFLEX/XIAPEX PIP Joint

Efficacy assessment based on modified intent-to-treat (mITT) population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure

Clinical Success

Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord

Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord

Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure

Percent Change From Baseline in Degree of Contracture

Change in Range of Motion

Very much improved

Much improved

Minimally improved

No change

Minimally worse

Much worse

Very much worse

Not done

Physician Global Assessment of Improvement

Very satisfied

Quite satisfied

Neither satisfied nor dissatisfied

Quite dissatisfied

Very dissatisfied

Subject Global Assessment of Satisfaction

Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure; only joints that were successfully treated (reduction in contracture to 5 degrees or less) 30 days after last injection were assessed

Recurrence of Contracture

Overall Study

Urdaneta Veronica, MD

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.

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.

CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture	NCT05440240	Dupuytren Contr... Dupuytren's Dis... Contracture Joint Diseases Musculoskeletal... Fibroma Neoplasm, Fibro... Neoplasms, Conn... Neoplasms, Conn... Neoplasms by Hi... Neoplasms Connective Tiss...	Percutaneous ne... Corticosteroid ... Saline injectio...	45 Years - 99 Years	Regionshospitalet Silkeborg
Retreatment of Recurrent Dupuytren's Contractures	NCT01498640	Dupuytren's Dis...	Collagenase clo...	18 Years -	Endo Pharmaceuticals
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture	NCT05440240	Dupuytren Contr... Dupuytren's Dis... Contracture Joint Diseases Musculoskeletal... Fibroma Neoplasm, Fibro... Neoplasms, Conn... Neoplasms, Conn... Neoplasms by Hi... Neoplasms Connective Tiss...	Percutaneous ne... Corticosteroid ... Saline injectio...	45 Years - 99 Years	Regionshospitalet Silkeborg
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture	NCT05440240	Dupuytren Contr... Dupuytren's Dis... Contracture Joint Diseases Musculoskeletal... Fibroma Neoplasm, Fibro... Neoplasms, Conn... Neoplasms, Conn... Neoplasms by Hi... Neoplasms Connective Tiss...	Percutaneous ne... Corticosteroid ... Saline injectio...	45 Years - 99 Years	Regionshospitalet Silkeborg
CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment	NCT01715467	Dupuytren's Con...		18 Years -	Endo Pharmaceuticals
Retreatment of Recurrent Dupuytren's Contractures	NCT01498640	Dupuytren's Dis...	Collagenase clo...	18 Years -	Endo Pharmaceuticals
CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment	NCT01715467	Dupuytren's Con...		18 Years -	Endo Pharmaceuticals

Spots Global Cancer Trial Database for contracture

Every month we try and update this database with for contracture cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for contracture

Every month we try and update this database with for contracture cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for contracture cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.