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Trial Comparing Treatment Strategies in Dupuytren's Contracture

2017-06-20 02:08:21 | BioPortfolio

Summary

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.

Description

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.

Study Design

Conditions

Dupuytren Contracture

Intervention

Percutaneous needle fasciotomy, Collagenase Clostridium Histolyticum 2.9 MG/ML [Xiaflex], Limited fasciectomy

Location

Central Hospital of Central Finland
Jyväskylä
Keski-Suomi
Finland
40620

Status

Not yet recruiting

Source

University of Tampere

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-06-20T02:08:21-0400

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Comment on "The Technique of Enhanced Percutaneous Needle Fasciotomy (PNF+) for Dupuytren's Contracture".

Medical and Biotech [MESH] Definitions

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 3.4.24.3.

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.

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Usage of a single needle among two or more people for injecting drugs. Needle sharing is a high-risk behavior for contracting infectious disease.

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