Effectiveness of Percutaneous Needle Aponeurotomy

Scientific justification:

Dupuytren's disease is a world-wide musculoskeletal disorder. It consists in fibrosis of the palmar aponeurosis that can induce disabling flexion contracture of the metacarpophalageal or proximal interphalangeal joints. Treatment modalities of flexion contracture include open surgery, percutaneous needle aponeurotomy and collagenase. Collagenase is not available in France. Aponeurectomy, that is also called fasciectomy, is the main open surgical technique, and open surgery is the most frequently used treatment in Dupuytren's disease. Percutaneous needle aponeurotomy is recommended as a nonsurgical treatment for Dupuytren's disease. It is a minimally invasive procedure. Its most largely accepted indication is Dupuytren's disease with metacarpophalageal joint involvement. However, percutaneous needle aponeurotomy has been successful for metacarpophalageal or proximal interphalangeal joint involvement, in nonadvanced and in advanced Dupuytren's disease. A model analysis recently demonstrated that replacing open surgery with percutaneous needle aponeurotomy could save more than 50% of the total hospitalization costs for the disease.

Percutaneous needle aponeurotomy therefore appears as a unique minimally invasive approach for Dupuytren's disease. It could become a valuable alternative to open surgery. The hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety profile for large application in the treatment of Dupuytren's disease and that it is consequently able to drastically reduce the need of open surgery in this indication.

Practical procedure:

Patients addressed to the consultation of the hand surgery centers for Dupuytren's disease will be prospectively selected, included, randomized, treated using percutaneous needle aponeurotomy or open surgery within six weeks after randomization, and followed at 1 week, 1, 3,12, 24 and 36 months after treatment. Assessment of efficacy will be blinded. Assessment of complications will be done by an unblinded assessor.

• Metacarpophalangeal joint contractures during passive and active extension [Срок оценки: at 1 week, 1, 3, 12, 24 and 36 months after treatment]
• Main metacarpophalangeal joint contracture during passive extension, [Срок оценки: at 36 months after treament]
• The clinical success [Срок оценки: at 3 months after treament]
• The recurrence [Срок оценки: at 12, 24 and 36 months after treament]
• The interphalangeal joint contractures during passive and active extension [Срок оценки: at 1 week, 1, 3,12, 24 and 36 months after treatment]
• The 70% improvement from baseline of the flexion contracture [Срок оценки: at 1 week, 1, 3, 12, 24 and 36 months after treatment]
• The active range of motion of metacarpophalangeal and proximal interphalangeal treated joints [Срок оценки: at 1 week, 1, 3, 12, 24 and 36 months after treatment]
• The functional limitation using Quick DASH questionnaire [Срок оценки: at 1 week, 1, 3, 12, 24 and 36 months after treatment]
• The URAM scale [Срок оценки: at 1 week, 1, 3, 12, 24 and 36 months after treatment]
• The patient satisfaction on a 0-100 mm visual analog scale [Срок оценки: at 1 week, 1, 3, 12, 24 and 36 months after treatment]
• The number of secondary and repeated treatments [Срок оценки: at 12, 24 and 36 months after treatment]
• Complications and adverse events for primary treatment [Срок оценки: at the treatment time, and at 1 week, 1, 3, 12, 24 and 36 months;]