Dupuytren’s contractures (DC) are fibrous formations under the skin of the hand that cause fingers to curl towards the palm, leading to functional limitations despite being typically painless. The UK’s National Health Service (NHS) predominantly employs two treatment methods: surgical removal of contractures (limited fasciectomy) and minimally invasive division using a needle (needle fasciotomy). This study investigates the clinical and cost-effectiveness of needle fasciotomy (NF) compared to limited fasciectomy (LF) in treating DC, focusing on patient-reported hand function and resource utilization.
The Hand-2 trial is a national, multi-centre, randomized study involving two parallel groups. Patients eligible for this trial must be 18 years or older with an untreated finger having a Dupuytren’s contracture of 30° or more, causing functional issues and suitable for either NF or LF. However, those with contractures limited to the distal interphalangeal joint are excluded. Participants will be randomly assigned in a 1:1 ratio to receive either NF or LF, with follow-up extending over 24 months post-treatment.
Study Design and Primary Outcomes
The primary outcome measure is the patient-reported hand function, evaluated via the Hand Health Profile of the Patient Evaluation Measure (PEM) questionnaire at 12 months post-treatment. Secondary outcomes encompass additional patient-reported metrics, the extent of finger movement loss, and cost-effectiveness, all assessed over the 24-month period. A QuinteT Recruitment Intervention will be implemented to enhance participant recruitment.
Secondary Outcomes and Qualitative Research
Secondary outcomes include other patient-reported measurements, finger movement loss, and cost-effectiveness, observed throughout the 24 months following treatment. Moreover, embedded qualitative research will delve into patient experiences and the acceptability of treatments after two years post-surgery.
Key Inferences
– Needle fasciotomy may provide a less invasive alternative with comparable efficacy to limited fasciectomy.
– Evaluating the cost-effectiveness of both treatments could influence NHS resource allocation.
– Understanding patient-reported outcomes is crucial for assessing the true impact of these treatments on daily hand function.
– The study’s findings might inform future clinical guidelines for treating Dupuytren’s contractures.
The investigation aims to determine if needle fasciotomy can be considered non-inferior to limited fasciectomy regarding patient-reported hand function one year post-treatment, potentially offering a less invasive and cost-effective treatment option for DC.
Original Article: Trials. 2024 Jun 19;25(1):398. doi: 10.1186/s13063-024-08003-1.
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