Efficacy and Cost-Effectiveness of Collagenase Clostridium Histolyticum, Percutaneous Needle Fasciotomy, and Limited Fasciectomy in Dupuytren's Contracture

The primary objective of the Dupuytren Treatment Effectiveness Trial (DETECT) is to evaluate the **efficacy** and cost-effectiveness of three treatment strategies for **Dupuytren's contracture** over a 5-year follow-up period. The strategies include: 1) primary percutaneous needle fasciotomy (PNF) followed by surgical limited fasciectomy (LF) for non-responders, 2) primary collagenase clostridium histolyticum (CCH) followed by surgical LF for non-responders, and 3) LF as both the primary and secondary treatment modality. This objective is clinically relevant as it aims to identify the most effective and economically viable treatment approach for patients with mild to moderate Dupuytren's contracture, potentially influencing future clinical guidelines and patient management strategies.

Secondary objectives include comparing the clinical outcomes of these three treatment strategies at 3 months, 2 years, 5 years, and 10 years. This long-term evaluation is crucial for understanding the durability and sustained effectiveness of each treatment option, thereby providing comprehensive insights into their long-term benefits and potential drawbacks.

The clinical trial focuses on evaluating treatment strategies for **Dupuytren's contracture**. The study population includes both male and female participants, aged over 18 years, who are not part of a vulnerable population. Participants are required to have at least a 20° combined extension deficit in the metacarpophalangeal joint and/or proximal interphalangeal joint in fingers II-V, a palpable cord, and the ability to provide informed consent and complete Finnish versions of questionnaires. The sponsor has not provided information regarding the total number of participants. The trial population was selected based on specific inclusion criteria, ensuring that participants meet the necessary health conditions related to the study's objectives. No specific lifestyle considerations such as diet or physical activity are highlighted in the available data.

The clinical trial is designed to evaluate the efficacy and cost-effectiveness of three treatment strategies for **Dupuytren's contracture** over a five-year follow-up period. This is a prospective, randomized, controlled, outcome assessor-blinded, three-armed parallel trial with a 1:1:1 allocation ratio. The trial involves multiple centers and aims to compare the effectiveness of collagenase clostridium histolyticum, percutaneous needle fasciotomy, and limited fasciectomy as treatment modalities. The trial is authorized to run from September 15, 2017, with an estimated end date of December 31, 2032.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as a minimum of 20° combined extension deficit in specific finger joints, age over 18 years, and the presence of a palpable cord. Informed consent and the ability to complete Finnish questionnaires are also required. The primary endpoint is the success of the treatment at five years. The trial does not specify secondary endpoints.

Study visits will include follow-up assessments to monitor treatment response and any adverse effects. The end-of-study visit will evaluate the long-term outcomes of the treatment strategies. The expected length of participant involvement is up to five years, with conditions for early termination including withdrawal of consent or significant adverse events. The trial is not categorized as low intervention and is classified as a Phase III study.

The clinical trial involves the use of **collagenase** as the experimental medication. **Collagenase** is provided in the form of a powder and solvent for solution for injection. The active substance, **collagenase**, is a mixture, and the pharmaceutical form is specifically designed for injection. The maximum daily dose of **collagenase** is 0.9 mg, with a total maximum dose of 2.7 mg over the treatment period. The administration route is via injection, and the treatment period is limited to a maximum of 3 months. The medication is not formulated for pediatric use, and it is not classified as an orphan drug.

In addition to the experimental treatment, the study includes non-experimental treatments as part of the trial design. These include percutaneous needle fasciotomy (PNF) and limited fasciectomy (LF), which serve as comparator treatments. The trial is structured to evaluate the efficacy and cost-effectiveness of these treatments in comparison to **collagenase** for the management of mild to moderate Dupuytren’s contracture. The study is designed as a prospective, randomized, controlled, outcome assessor-blinded, three-armed parallel trial with a 1:1:1 allocation ratio.

Participant compliance with the dosing schedule and administration of the treatments will be monitored throughout the trial. The trial aims to determine the most effective and cost-efficient treatment strategy over a 5-year follow-up period. The study does not include a placebo group, as the focus is on comparing the active treatments directly.

The efficacy of the treatment strategies in the clinical trial titled "DupuytrEn Treatment EffeCtiveness Trial (DETECT)" will be assessed by evaluating the primary endpoint of "Success at five years." This trial aims to compare the efficacy and cost-effectiveness of three treatment strategies for **Dupuytren's contracture**: primary percutaneous needle fasciotomy (PNF) followed by surgical limited fasciectomy (LF) for non-responders, primary collagenase clostridium histolyticum (CCH) followed by surgical LF for non-responders, and LF as both primary and secondary treatment. The assessment will be conducted in a prospective, randomized, controlled, outcome assessor-blinded, three-armed parallel 1:1:1 multicenter trial. The primary endpoint will be measured at the five-year follow-up to determine the long-term success of each treatment strategy. The trial will utilize validated scales and patient-reported outcomes to collect and analyze data on the efficacy of the interventions. The study is designed to provide comprehensive insights into the most effective treatment approach for patients with mild or moderate Dupuytren's contracture over a five-year period.