Track topics on Twitter Track topics that are important to you
Trial is a prospective, randomized, controlled, outcome assessor-blinded, three armed parallel 1:1:1, multicenter trial. The research objective is to determine, which treatment strategy 1) primary percutaneous needle fasciotomy (PNF) followed by surgical limited fasciectomy (LF) in patients who do not respond to PNF, 2) primary collagenase clostridium histolyticym (CCH) followed by LF in patients who do not respond to CCH or 3) LF as the primary (and secondary) treatment modality is the most efficacious and cost-effective in treating Dupuytren´s contracture.
Dupuytren's contracture (DC) is a fibroproliferative disorder of the palmar fascia, which in time leads to flexion contracture in one or more fingers. Etiology of the disease is still unknown, but it strongly seems that genetic factors play a major role. DC is associated most commonly with Caucasian population groups from Northern Europe. The estimated global prevalence among whites is 3% to 6%, and increases with age. Men women ratio is 7:1. There is no definitive cure for DC. The treatment aims at relieving the symptoms by releasing the contracture by percutaneous or operative techniques.
The investigators planned a prospective, randomized, controlled, outcome assessor-blinded, three armed parallel 1:1:1, multicenter trial comparing the efficacy and cost-effectiveness of 1) collagenase clostridium histolyticum followed by limited fasciectomy in non-responsive cases, 2) percutaneous needle fasciotomy followed by limited fasciectomy in non-responsive cases and 3) primary limited fasciectomy in short and long term follow-up for mild or moderate stage DC.
Protocol is approved by Tampere university hospital institutional review board and Finnish Medicine Agency (Fimea). All patients will give written informed consent. The results of the trial will be disseminated as published articles in peer-reviewed journals.
Treatment of Duputren's contracture aims at reducing the functional deficit caused by the contracture. Recurrence is almost inevitable, if the follow-up is long enough. Therefore, the investigators aim to analyze the efficacy of three different treatment strategies, which include multiple interventions rather than just single intervention. The investigators chose a pragmatic primary outcome, which comprises both objective and subjective standpoint and reflects the needs of the patients as well as goals of the healthcare system. Furthermore, our long-term follow-up gives a good perspective to the cost effectiveness of the strategies.
Percutaneous needle fasciotomy, Collagenase Clostridium Histolyticum 2.9 MG/ML [Xiaflex], Limited fasciectomy
Central Hospital of Central Finland
Not yet recruiting
University of Tampere
Published on BioPortfolio: 2017-06-20T02:08:21-0400
The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures.
To evaluate the effect of collagenase clostridium histolyticum treatment at the Department of Orthopaedic surgery at Horsens Regional Hospital after minimum one-year follow-up (FU).
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 inves...
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 t...
The purpose of this study is to determine whether collagenase is effective in reducing the surface area of a subcutaneous benign lipoma.
The extended percutaneous needle fasciotomy (PNF+) is a minimal invasive technique especially suitable for treating severe Dupuytren's contractures and recurrences. The familiar needle fasciotomy is c...
Secreted virulence factors like bacterial collagenases are conceptually attractive targets for fighting microbial infections. However, previous attempts to develop potent compounds against these metal...
In recent years, there have been increasing indications for percutaneous renal biopsy. Fine-needle aspiration (FNA), with or without core needle biopsy (CB), has been used increasingly in the manageme...
A species of gram-positive, strongly proteolytic bacteria in the family Clostridiaceae. It contains several forms of COLLAGENASE whose action can lead to GAS GANGRENE in humans and HORSES.
A metalloproteinase which degrades helical regions of native collagen to small fragments. Preferred cleavage is -Gly in the sequence -Pro-Xaa-Gly-Pro-. Six forms (or 2 classes) have been isolated from Clostridium histolyticum that are immunologically cross-reactive but possess different sequences and different specificities. Other variants have been isolated from Bacillus cereus, Empedobacter collagenolyticum, Pseudomonas marinoglutinosa, and species of Vibrio and Streptomyces. EC 126.96.36.199.
Percutaneous excision of a herniated or displaced intervertebral disk by posterolateral approach, always remaining outside the spinal canal. Percutaneous nucleotomy was first described by Hijikata in Japan in 1975. In 1985 Onik introduced automated percutaneous nucleotomy which consists in percutaneous aspiration of the nucleus pulposus. It is carried out under local anesthesia, thus reducing the surgical insult and requiring brief hospitalization, often performed on an outpatient basis. It appears to be a well-tolerated alternative to surgical diskectomy and chymopapain nucleolysis.
A family of percutaneous techniques that are used to manage CORONARY OCCLUSION, including standard balloon angioplasty (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY), the placement of intracoronary STENTS, and atheroablative technologies (e.g., ATHERECTOMY; ENDARTERECTOMY; THROMBECTOMY; PERCUTANEOUS TRANSLUMINAL LASER ANGIOPLASTY). PTCA was the dominant form of PCI, before the widespread use of stenting.
Usage of a single needle among two or more people for injecting drugs. Needle sharing is a high-risk behavior for contracting infectious disease.
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...