BOND Study

  • Research type

    Research Study

  • Full title

    The clinical effectiveness of night-time splinting after collagenase injection and manipulation therapy in patients with Dupuytren’s; The BOND randomised control trial.

  • IRAS ID

    206509

  • Contact name

    Daniel Brown

  • Contact email

    daniel.brown@rlbuht.nhs.uk

  • Sponsor organisation

    Royal Liverpool University Hospital

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    This randomised control trial is designed to assess the impact of wearing a splint overnight on the recurrence of Dupuytren’s contracture after patients have undergone injection and manipulation of the affected finger. Dupuytren’s contracture is a disorder that affects the palms of patient’s hands resulting in debilitating fixed flexion deformities of the fingers. Surgery is effective however the disease can reoccur leading to reformation of these contractures.\n\nCurrently we use these splints in clinical practice to prevent reformation of contractures but the evidence for them is limited and patients poorly tolerate them. In investigating their utility for preventing recurrence we will be able to tailor our post-operative therapy and improve patient outcomes.\n\nWe will be including patients who have successful collagenase injection and manipulation therapy of a single finger and randomising them to splinted and un-splinted groups with no other difference in their treatment. After their routine follow-up we will see them in clinic at 3, 6 and 12 months. We will be assessing the range of motion of the joint at these time points and will be giving two questionnaires to assess the functional impact on patients postoperatively. We are intending for this to be performed in multiple centres in England with the results collated centrally in the Royal Liverpool and Broadgreen University Hospital Trust.\n

  • REC name

    North West - Greater Manchester East Research Ethics Committee

  • REC reference

    17/NW/0186

  • Date of REC Opinion

    3 May 2017

  • REC opinion

    Further Information Favourable Opinion