Musculoskeletal Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Contracture

Dupuytren Contracture

Joint Diseases

Muscular Diseases

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Connective Tissue Diseases

1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual

percutaneous needle fasciotomi is performed at affected cords

xiapex

percutaneous needle fasciotomy

hallgeir bratberg, MD

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.

Prospective randomized study between Percutanous Needle Fasciotomy and Xiapex for Dupuytrens contracture.

A total of 50 patiens are to be randomized to eighter percutaneous needle fasciotomy or Xiapex treatment.

The patients randomized to xiapex treatment are treated as described in the product manual. Extentin treatment after one day.

The patients randomized to percutaneous needle fasciotomy are treated with the cutting teqnique: A littel quaddle local anestesia (xylocaine with adrenaline) is to be injected subcutant over the cord. After thet we use a 19G needle to cut the cord sufficient number sites to extend the finger.

The patients will be follwed up at 3 weeks, 3 months, 1 year, 3 years and 5 years. Investigators record contracture size, quicq-DASH, pain (VAS) and hand disability (VAS) pretreatment and at all controlls. At 3 weeks investigators register procedure complain. Side effects and complications, and advere effects are also to be investigated.

Our hypothesis is that it is no difference between the two methods in regard of contracture size after five years.

Inclution criteria: Symptomatic primary Dupuytrens contracture with palpable cord in one to three fingers, involving MCP, and total contracture size is over 30 degrees. Patient age over 18 years.

Exclution criteria:

Previously treated Dupuytrens contracture in the same hand more than tree affected fingers we will not include thumbs Other symptomatic injury or disease influencingf hand function ASA\>3 Expected lifetime less than five years tetracycline treatment within two weeks pregnancy nursing allergy to clostridium histolyticum concmittent other clinical trial

Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture

Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur

contracture size mesured in degrees in each finger joint

Quick-DASH functional score measured in points.

Contracture size mesured in degrees in each finger joint

Oslo University Hospital

Injection of collagenase obtained from Clostridium Histolyticum in contracture string

Xiapex

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Percutaneous needle fasciotomy

Jeppe Lange, M.D.

Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial.

Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

Comparing Injectable Collagenase (CI) and Percutaneous Needle Fasciotomy (PNF) for Dupuytren's Contracture (DC) Affecting Proximal Interphalangeal Joints (PIP). A Randomised Controlled Trial

Clinical improvement is defined as a contracture reduction 50% or more from baseline.

Jeppe Lange, MD

M:D:

Anti-Inflammatory Agents

Antineoplastic Agents

All Drugs and Chemicals

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Percutaneous needle fasciotomy with corticosteroid injection

Percutaneous needle fasciotomy with saline injection

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

Instead of the usual treatment with a night splint for three months after percutaneous needle fasciotomy patients do not receive treatment with a night splint.

No night splint

Daniel Muder, MD

Antje Straatmann, MD

Anna-Karin Tibell, MD

Madeleine Harryson, MD

Stephan Wilbrand, MD, PhD

Dupuytren's contracture (DC) is associated with progressive finger flexion and extension deficit caused by fibrosis in the palm and digits. Treatment options include minimally invasive procedures such as percutaneous needle fasciotomy (PNF) and collagenase clostridium histolyticum injections as well as open fasciectomy. PNF has recently become more popular in Sweden because it is an office-based procedure which is relatively easy to perform without the usual risks and costs of open surgery.

After treatment with PNF patients usually continue with supervised rehabilitation, which includes physical therapy and night splinting. Whether night splinting is beneficial in terms of reducing recurrence of DC is currently debated.

This study aims to investigate whether night splinting after performed PNF helps to reduce recurrence rate or not. Patients who meet the inclusion criteria will be randomized into two groups: The first group will be treated as usual with physical therapy and night splinting after PNF. The second group will be treated with physical therapy without night splinting after PNF. Follow up includes physical examination regarding active range of motion, sensation and grip strength at procedure day and 2 weeks, 3, 12 and 36 months later as well as questionnaires regarding hand function, pain and quality of life at procedure day and 3, 12 and 36 months later. Patients who are randomized into the second group (no night splinting) will also be examined 3 weeks after PNF for observation in case of an early impairment regarding extension deficit.

Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture

Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture - a Randomised Controlled Multicenter Trial

Finger joint movement in order to extend the finger measured in degrees with a goniometer before and after treatment.

Finger joint movement in order to flex the finger measured in degrees with a goniometer before and after treatment.

The ability to grip with the hand measured with the Jamar hand dynamometer in kg before and after treatment.

Report of pain in the treated finger using a numeric rating scale from 0 to 10, where 0 is equivalent to no pain at all and 10 is equivalent to the highest thinkable pain level.

Quality of life is measured by the EQ-5D questionnaire. This questionnaire is developed by the EuroQuol Group and measures 5 health dimensions: mobility, self care, usual activities, pain and discomfort, as well as anxiety and depression. The answers are transferred into an EQ-5D index from 0 to 1, where 0 is equivalent with the worst health state and 1 is equivalent with the best health state.

The URAM (Unité Rhumatologique des Affections de la Main) scale is a 9-item questionnaire for functional assessment in Dupuytren's disease with a range from 0-45 points, where 0 is equivalent with the best functional outcome and 45 is equivalent with the worst functional outcome.

Semmes-Weinstein monofilament test is a semi-quantitative test for sensory loss. Filaments in different sizes are used to put a different amount of pressure onto the skin. Depending on which filament size the patient is able to detect sensory loss can be investigated.

In this questionnaire the patient answers questions about present conditions such as diabetes and smoking, therapy with pain medication for the hand, how long the patient has been diagnosed with Dupuytren'd disease, if both hands are affected and if there is a positive family history.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture	NCT02476461	Dupuytrens Cont...	xiapex percutaneous ne...	18 Years -	Oslo University Hospital
Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture	NCT01538017	Dupuytrens Cont...	Xiapex Percutaneous ne...	18 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
Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture	NCT01538017	Dupuytrens Cont...	Xiapex Percutaneous ne...	18 Years - 99 Years	Regionshospitalet Silkeborg
Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture	NCT02476461	Dupuytrens Cont...	xiapex percutaneous ne...	18 Years -	Oslo University Hospital
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
Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture	NCT05300893	Dupuytren Contr... Dupuytren's Dis...	No night splint	18 Years -	Uppsala University

Spots Global Cancer Trial Database for percutaneous needle fasciotomy