DISTRACT

Study Title: A feasibility study of a non-surgical joint distraction orthosis to treat thumb base osteoarthritis

Background

Osteoarthritis (OA) is a process that occurs with aging and describes the weakening of the joint cartilage. Thumb arthritis is the second most common type of arthritis in the hand. The joint at the base of the thumb is commonly affected in those living with hand osteoarthritis. Thumb base Osteoarthritis (TBOA) causes pain and loss of function. Available treatments attempt to relieve symptoms but do not modify the disease process. Approximately 5,000 patients in the UK and 100,000 patients in the USA undergo surgery for end stage disease each year. This project meets four of the ten priorities identified in the James Lind Alliance Priority Setting Partnership for hand conditions. These include finding alternatives to surgery, building better evidence, and comparing surgery with non-surgical treatments.

Aims and Objectives

The aim of this study is to develop a wearable orthosis that sits on the thumb and gently separates the joint at the thumb base. We expect this will improve symptoms and support recovery of the joint tissues. In due course, it is expected that the orthosis will be equally applicable to treat OA of other digits and be used to manage finger fractures. 

The key aim of this proof-of-concept study is to bring the new distraction orthosis to transfer readiness level 5. This will enable the conduct of a future large, randomised control trial to assess clinical efficacy and effectiveness.

Objectives includes:

• Completion of a feasibility study to inform a future RCT
• Assess the impact of the orthosis on activities of daily living and measure the orthosis fit using bioengineering techniques
• Confirm the market size and gain feedback from a broader range of patients and healthcare workers
• Sample Size: this study will involve twenty-six NHS patients with TBOA.