Dupuytren's contracture RCT

DupuytrEn Treatment EffeCtiveness Trial (DETECT)

Background

Dupuytren’s contracture is a fibroproliferative disease. Usually, the disease progresses slowly, and the cords causing the flexion contracture of the finger take years to develop. However, the disease also has a manifestation named Dupuytren’s diathesis with a significantly more aggressive course of disease. The condition is more common among males than females, and it is associated with genetic predisposition. Typically, the contracture starts to develop in late middle age, and prevalence rises with age. It is likely that with the ageing population Dupuytren’s contracture cases will increase over time. The estimated global prevalence among whites is believed to be at about 3% to 6%. The etiology of the disease remains uncertain, but risk factors believed to contribute to the development of Dupuytren’s include micro-traumas, smoking, heavy alcohol consumption, diabetes and epilepsy.

The contracture most often develops in the ring or little finger. However, it can also affect the thumb, index finger and middle finger. As the contracture advances, it leads to impaired hand function and, for instance, putting gloves on might become difficult.

The classical treatment for Dupuytren’s contracture has been limited fasciectomy. Recently, there has been an increase in the use of clostridium histolyticum collagenase (Xiapex) as a treatment for Dupuytren’s contracture. The collagenase is injected into the contracture cord, which leads to enzymatic rupture of the cord.  Following the increased popularity of the collagenase treatment, also percutaneous needle fasciotomy has resurged. Percutaneous needle fasciotomy has been used as a treatment for Dupuytren’s contracture for decades already. In this method the contracture cord is divided with the aid of a needle.

Objective

The objective of the study is to identify the best treatment strategy for Dupuytren’s contracture in terms of effectiveness, patient satisfaction and cost-effectiveness over a long follow-up period. The primary outcome measure in the study is passive extension deficit.

No other comparative studies between clostridium histolyticum collagenase treatment, percutaneous needle fasciotomy and limited fasciectomy have been conducted or are known to be in progress at present.

Study status

The study design is prospective randomized blinded multicentre trial. At present, the following centres have enrolled: Tampere University Hospital, Central Finland Central Hospital, Helsinki University Central Hospital, Turku University Central Hospital and Oulu University Hospital. Eventually, six centres will be involved. Patient recruitment started in 2017. The study focuses on two joints (MP and PIP joint), and the aim is to enrol 45 patients in each group. According to power calculations, a total of 270 patients will provide sufficient statistical significance.

Study team

Senior researchers: Teemu Karjalainen, Specialist in Hand Surgery and Docent, Chief Physician, Central Finland Central Hospital and Olli Leppänen, Specialist in Hand Surgery and Docent, Chief Physician, Tampere University Hospital

Junior researchers: Mikko Räisänen, Specialist in Hand Surgery, Kuopio University Hospital and Janne Soikkeli, Specialist in Hand Surgery, Chief Physician, Oulu University Hospital

Study Protocol

The study protocol has been peer reviewed and published in BMJ Open: DupuytrEn Treatment EffeCtiveness Trial (DETECT): a protocol for prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of collagenase clostridium histolyticum, percutaneous needle fasciotomy and limited fasciectomy as short-term and long-term treatment strategies in Dupuytren’s contracture