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Dupuytren Contracture clinical trials

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NCT ID: NCT03031080 Withdrawn - Clinical trials for Dupuytren Contracture

BOND Study: the Benefit Of Night Splinting in Dupuytrens'

BOND
Start date: June 1, 2017
Phase: N/A
Study type: Interventional

The BOND study is a prospective, randomised single blinded controlled trial to assess the effect of night splinting in patients who have had collagenase injection and manipulation therapy for Dupuytren's Contracture.

NCT ID: NCT03000114 Recruiting - Clinical trials for Dupuytren Contracture

Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Dupuytren's disease is a non-curative, progressive disorder leading to function-impairing deformities of the hand. Although numerous treatments exist, the most common and widely accepted therapy is removal of diseased fascia. Surgery is limited by prolonged recovery time, and many patients require multiple surgeries throughout their life as the disease progresses, with repeat surgeries increasing the risk of complications. Long recovery times and need for repeat surgeries has renewed interest in minimally invasive treatments for Dupuytren's disease. Percutaneous needle aponeurotomy (PNA) allows for rapid improvement in finger extension with minimal recovery time. The FDA approved collagenase clostridium histolyticum injection for Dupuytren's disease in 2010, which also allows for rapid increase in finger extension, also with minimal recovery time. Currently there is only one small study comparing PNA and collagenase injection (CI) that suggests similar outcomes in both treatments. Both treatments are minimally invasive, requiring minimal time off work and post-procedure pain. The main barrier to widespread adoption of CI is cost, particularly in patients with multiple areas of disease requiring treatment. The project proposed will compare these two methods for treating Dupuytren's disease. Approximately 334 participants will be recruited from patients referred for treatment to hand surgeons trained in CI and PNA at two Calgary, AB hospitals. Need for treatment will be determined in the usual fashion, and the option for entry into the study will be proposed to patients meeting inclusion/exclusion criteria. Participants will be randomized into either the PNA or CI treatment group. The surgeon will not be blinded to the procedure group; however, the therapist measuring outcomes will be, and the study participants will need to not divulge to the therapists which group they are in. Both procedures are performed under local freezing, and range from 5-20minutes. PNA involves the surgeon freezing the skin over the Dupuytren's cord, then using a small gauge needle inserted under the skin to cut the cord. This is repeated up the length of the cord to weaken it, allowing the surgeon to extend the finger and rupture the cord. CI involves the injection of collagenase (Xiaflex®), directly into the Dupuytren's cord. The patient then returns to see the surgeon within one week, has freezing placed in the hand, and the affected digit is extended to rupture the already weakened cord. The patient will be required to present to the hand therapist team for measurements of joint angles before and after the assigned treatment is performed. In order to measure treatment efficacy, study participants will be required to return for measurements of treated joints every 6 months. Lastly, participants will need to inform the performing surgeon or therapist, at follow-up visits of any complications they experience.

NCT ID: NCT02983162 Completed - Clinical trials for Dupuytren Contracture

Is wGRS Associated With DD Recurrence?

Start date: March 10, 2017
Phase:
Study type: Observational

Rationale: Retrospectively reviewing the participants of the GODDAF database, revealed a significant association between the weighted genetic risk score and Dupuytren disease recurrence. However, a significant dose-response relation was not found. This might be caused by underestimating the recurrence rate, due to the retrospective nature of determining recurrence. Therefore, we want to do a follow-up measurement of the GODDAF participants, to see whether they suffered from recurrent disease. Objective: We aim to determine whether the wGRS is associated with recurrent DD. Study design: An observational study, in which the participants of the GODDAF study are followed up. Study population: Patients affected by Dupuytren disease, aged 18-96 years, who were previously included in another study on the genetic basis of Dupuytren disease. Intervention (if applicable): NA Main study parameters/endpoints: The main study parameter is the presence of recurrent Dupuytren disease.

NCT ID: NCT02725528 Completed - Dupuytren's Disease Clinical Trials

Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's

EXTEND
Start date: July 8, 2017
Phase: Phase 3
Study type: Interventional

This is a prospective, multi-centre, pragmatic randomized controlled trial to compare both the clinical effectiveness and cost-effectiveness of collagenase injections (CI) versus limited palmar fasciectomy (LPF) to determine if collagenase is a superior treatment in terms of improved quality of life and reducing recurrence of the disease without serious complications. Since collagenase injections are costly it is also important to know if this novel intervention is cost-effective from the patient, Ministry of Health and societal perspectives.

NCT ID: NCT02647619 Completed - Clinical trials for Dupuytren Contracture

Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF

Start date: October 2013
Phase: Phase 4
Study type: Interventional

Aim: Clinical RCT comparing functional results and recurrence rate following enzymatic treatment vs. needle aponeurotomy. Materials and methods: 30° or more contracture of only one metacarpophalangeal (MCP) joint contracture of one of the three ulnar digits and less than 20° for the adjacent proximal interphalangeal (PIP) joint. Patients with primary disease of the hand. Total of 80 patients needed to detect difference of 13.5°. 1) Needle aponeurotomy 2) Clostridium Histolyticum treatment. Clinical follow ups 1,4 weeks, 16 weeks and 1,2 and 5 years. Functional outcome scores: URAM, Quick Dash, EQ5D, brief MHQ, VAS pain and VAS patient satisfaction. Total passive extension contracture reduction, recurrence rate and registration of complications.

NCT ID: NCT02476461 Recruiting - Clinical trials for Dupuytrens Contracture

Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture

PNFvsxiapex
Start date: April 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate whether percutaneous needle fasciotomy is as effective for treating Dupuytrens contracture as Xiapex. Immidiate treatment effect is to be investigated, as iskontracture size after 5 years. Contracture size after one and three years, and subjective hand function is also to be investigated.

NCT ID: NCT02474576 Completed - Dupuytren Disease Clinical Trials

Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease

APADUP
Start date: September 2015
Phase: N/A
Study type: Interventional

The efficiency of percutaneous aponeurotomy in the treatment of Dupuytrens disease is well known. However, the duration of the clinical improvement after aponeurotomy is not well known. This study aims primarily at measuring the incidence rate of local relapse of Dupuytrens-induced finger flessum, within two years following treatment by percutaneous aponeurotomy in Dupuytrens.

NCT ID: NCT02301078 Recruiting - Dupuytren Disease Clinical Trials

Short-term Function and Pain After Treatment for Dupuytren's Disease

Start date: July 2014
Phase: N/A
Study type: Observational

This study will evaluate short-term pain and function associated with percutaneous needle aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum in patients with Dupuytren's disease. Scores on outcome measures will be compared between groups to determine whether treatments differ in terms of hand function and pain during the early post-treatment period.

NCT ID: NCT02294890 Not yet recruiting - Fibrosis Clinical Trials

Knee Stiffness in Fibrosis Diathesis

Start date: January 2015
Phase: N/A
Study type: Observational

At the standard follow-up moment one year after primary TKA for gonarthrosis, all patients will be checked for signs of fibrosis diathesis. This will be done by examining their hands for Dupuytren's nodules and contractures and recording risk factors associated with increased severity and risk of recurrence of Dupuytren's contracture. These include family history, bilateral DD, and ectopic lesions, age of onset less than 50 years, male gender, Ledderhose disease, first ray involvement, multiple ray involvement and ectopic fibromatosis. This way, two groups of patients will be identified: those with and those without signs of fibrosis diathesis. For both groups, the range of motion (ROM) of the operated knee at 3 and 6 months will be retrieved in the charts, the ROM at 12 months will be measured at that time. Also, additional procedures performed to increase ROM postoperatively will be retrieved from the charts (e.g. continuous passive motion, mobilization under anesthesia). Other causes for knee stiffness will have to be recorded, since these will be the most important exclusion criteria. In the patients with clear signs of finger contractures, any impression of increase of contracture over the past 12 months will be recorded.

NCT ID: NCT02193828 Completed - Dupuytren's Disease Clinical Trials

Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules

Start date: July 2014
Phase: Phase 2
Study type: Interventional

The objectives of this study are to assess the safety and effectiveness of AA4500 in treating palmar Dupuytren's disease nodules.