Wounds and Injuries

All Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Fractures, Bone

Edema

Contracture

Radius Fractures

Hand Injuries

Dupuytren Contracture

Wrist Fractures

Forearm Injuries

Arm Injuries

Wrist Injuries

Joint Diseases

Muscular Diseases

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Connective Tissue Diseases

Coagulants

All Drugs and Chemicals

Central Nervous System Depressants

Anti-Infective Agents

Tranexamic Acid

Anesthetics

Anti-Bacterial Agents

Antibiotics, Antitubercular

Hemostatics

Antifibrinolytic Agents

Patients in the TXA arm will receive 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride before their surgery and 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride 3-6 hours after the first dose on the day of their surgery

Patients in the (SOC) arm will receive 50cc of IV Placebo (standard intravenous normal saline fluid - 0.9% sodium chloride) before their surgery and 50cc of IV Placebo (standard intravenous normal saline fluid - 0.9% sodium chloride) 3-6 hours after the first dose on the day of their surgery

Patients will receive 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride before your surgery and 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride 3-6 hours after your first dose on the day of your surgery

Tranexamic acid

This will include regional anaesthesia, tourniquet inflation to 250mmHg and perioperative antibiotics. At the conclusion of the procedure hemostasis will be achieved followed by standard closure technique. There will be three separate surgical groups that will undergo the outlined study protocol: 1) Distal radius fractures will be treated with open reduction from a volar approach only technique 2) Mild dupuytren's: a. Low: i. MCP joints \<50 contracture ii. PIP joints \<40 contracture b. 1-2 fingers involved 3) Severe dupuytren's a. High: i. MCP joints \>50 degree contracture ii. PIP Joints \>40 degrees contracture b. \>2 fingers involved

Surgery

Hand edema following hand surgery is a common yet devastating side effect that can lead to early stiffness, prolonged rehabilitation and diminished function. These factors can reduce a patient's quality of life; mounting to an overall delay in recovery, return to work and daily activities. Conventional edema therapy includes cryotherapy, external compression, active and passive exercises and various types of massage. However, there is little evidence to suggest these modalities are effective. Tranexamic acid (TXA) is an antifibrinolytic that has been used in surgical disciplines for decades to aid in reducing intraoperative blood loss and consequent transfusions. Recently, the use of TXA for curbing post-operative edema and ecchymosis has shown promising results, however, its use in hand surgery has not been studied.

A Prospective, Randomized Controlled, Double-Blinded Pilot Study

The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery

The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery (THAW): A Prospective, Randomized Controlled, Double-Blinded Pilot Study

Assess number of patients who receive hand volume measurements at all designated time intervals. The outcome goal will be 90%

Asses proportion of patients who correctly receive the intervention as per the protocol. The outcome goal will be 90%

Proportion of participants to complete the study protocol and associated follow up. The outcome goal will be an 80% retention rate

Number of patients recruited to the study per month. The outcome goal will be 5 patients per month

Hand volume will be assessed using two validated methods; water displacement and figure of eight measurement.

Patient Reported Wrist and Hand Evaluation (PRWHE). The PRWHE allows patients to rate their levels of hand and wrist pain and disability. It is rated on a 0-100 scale. A higher score in the scale denotes a worse outcome

Ruby Grewal

Co-director of the clinical research lab within the Roth | McFarlane Hand and Upper Limb Center (HULC)

Patients with thumb 1st web contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase

Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections

Injectable clostridial collagenase

This study will evaluate the efficacy and safety of clostridial collagenase injections for treatment of Dupuytren's contracture of the thumb and first web space. The investigators hypothesis is that clostridial collagenase will have safety not significantly different to that demonstrated in Phase III clinical trials, and will be effective in significantly reducing the degree of thumb contracture.

Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb

The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures

Indiana Hand to Shoulder Center

Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace

Injectable Clostridial Collagenase

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

1 patient was seen at Day 10, but not at day 30. At Day 10, patient met the primary endpoint

F. Thomas D. Kaplan

>50% reduction in contracture

<50% reduction in contracture

Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)

Overall Study

Finger manipulation one day following Clostridial collagenase injectable

Finger manipulation two days following Clostridial collagenase injectable

Finger manipulation four days following Clostridial collagenase injectable

Finger manipulation performed 1, 2, or 4 days following collagenase injection

Clostridial collagenase injectable

F. Thomas D. Kaplan, MD

Lawrence C Hurst, MD

The purpose of this study is to determine if of manipulation of digits following collagenase injection for treatment of Dupuytren's contracture is effected by the amount of time between injection and manipulation.

Patients with Metacarpophalangeal joint contractures caused by Dupuytren's disease will be evaluated as to the timing of the finger manipulation procedure that is performed following collagenase injection. Three groups will be evaluated: group 1 will have the manipulation procedure on the day following collagenase injection, group 2 will have the manipulation procedure on the second day following collagenase injection,and group 3 will have the manipulation procedure on the fourth day following collagenase injection,

Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

A Post Market, Open-Label Study of the Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

Stony Brook University

Finger manipulation one day following collagenase injection

Day 1 Manipulation

Finger manipulation two days following collagenase injection

Day 2 Manipulation

Finger manipulation four days following collagenase injection

Day 4 Manipulation

Total

Study was terminated early due to slow enrollment

Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)

Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)

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

Endo Pharmaceuticals

Disease Progression

Anti-Inflammatory Agents

Antirheumatic Agents

Adalimumab

Tumor Necrosis Factor Inhibitors

Saline

Jagdeep Nanchahal, PhD FRCS

Dupuytren's disease is a very common condition, affecting 4% of the general UK and US population. It causes the fingers to curl irreversibly into the palm and can be extremely disabling. The disease usually starts as a small firm lump (nodule) in the palm, and in about 40% of patients advances to form cords that pull the fingers into the palm. There is no approved treatment for the early stage of disease. Once patients have established deformities, the diseased tissue can removed by surgery or cut using less invasive techniques such as a needle or an enzyme. However, recovery following surgery usually takes several months and recurrence rates with the less invasive techniques are high.

The investigators have unravelled the cellular process that initiates and maintains the disease progress and identified tumour necrosis factor (TNF) as a new target for treatment. Based on these findings the investigators plan to test the effects of adalimumab, an anti-TNF drug which currently approved for use in patients with rheumatoid arthritis and other inflammatory conditions. The aim of the study is to find out whether treatment by injection with adalimumab directly into the diseased tissue will control the advance of early Dupuytren's disease better than a placebo injection with normal saline.

The investigators will first carry out a small trial in up to 40 patients with established disease to determine the best dose that reduces the activity of the cells responsible for the disorder (Dose Response study). In this part patients who will be having surgery to remove their diseased tissue will receive a single injection of adalimumab into the nodule in their hand about 2 weeks before surgery. The tissue that is then removed during surgery will be analysed in the investigator's laboratories to determine the effect of the drug on the tissue. Patients will be followed for 12 weeks after surgery.

In the second part of the study the investigators will assess whether the optimal dose of the drug prevents early disease advancing in 138 patients (Early Disease study). Patients who take part in the second part of the study will receive a total of 4 injections of adalimumab into the nodule in their hand at three monthly intervals. They will then be checked at 3 \& 9 months after the last injection. In additional to assessing the effect of the injections on the nodule and hand function, information will also be collected to assess the cost effectiveness of the treatment.

During Dose Response part of the trial the Investigator will be blinded. During the Early Disease part of the trial the Investigator will not be blinded but will not carry out any outcome assessments.

Repurposing Anti-TNF for Treating Dupuytren's Disease

A Multi-centre, Double Blind, Randomised, Placebo-controlled, Parallel Group, Phase II Trial to Determine the Efficacy of Intra-nodular Injection of Anti-TNF to Control Disease Progression in Early Dupuytren's Disease, With a Dose Response.

Patient-completed questionnaire: numeric rating scale

Patient completed questionnaire about health \& social care and financial costs of Dupuytren's disease

Assessment of the injection site for pre-specified Adverse Events; surgery site assessment (Dose response only): wound assessment criteria, Centres for Disease Control and Prevention.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery	NCT04907812	Hand Injuries a... Distal Radius F... Dupuytren Contr...	Tranexamic acid Surgery	18 Years -	Lawson Health Research Institute
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb	NCT01265420	Dupuytren's Con...	Injectable clos...	18 Years -	Indiana Hand to Shoulder Center
Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture	NCT01226121	Dupuytren's Dis...	Clostridial col...	18 Years -	Indiana Hand to Shoulder Center
CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment	NCT01715467	Dupuytren's Con...		18 Years -	Endo Pharmaceuticals
Repurposing Anti-TNF for Treating Dupuytren's Disease	NCT03180957	Dupuytren's Dis...	Adalimumab Saline	18 Years -	University of Oxford
CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment	NCT01715467	Dupuytren's Con...		18 Years -	Endo Pharmaceuticals

Spots Global Cancer Trial Database for dupuytren

Every month we try and update this database with for dupuytren 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 dupuytren

Every month we try and update this database with for dupuytren 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 dupuytren 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.