Non-surgical joint distraction orthosis to treat thumb base osteoarthritis

Patients have prioritised new non-surgical treatments for hand osteoarthritis The joint at the base of the thumb is commonly affected in those living with hand osteoarthritis. Thumb base OA 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.

Key aim and objectives 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 include: 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 The non-surgical distraction orthosis is a new concept for hand osteoarthritis Custom distraction orthoses have been used to treat finger fractures (O'Brien 2010).

However, the distraction orthosis is a new invention. A patent has been filed and the first search did not identify prior art that might compromise the application. The International filing will go ahead in Q1 of 2021.

Joint distraction offers a paradigm shift in the treatment of OA Both animal and human studies support joint distraction as a disease modifying treatment.

Gardiner and Vincent reported that off-loading the forces through a mouse knee joint protects against experimental OA (Burleigh 2010, 2012).

Subsequent studies have shown reduced cartilage degeneration with surgical joint distraction compared with placebo distraction or no distraction (Chen 2015).

Surgical joint distraction appears to delay or remove the need for total joint replacement but is associated with complications including pin site infections and deep vein thrombosis (van der Woude 2017).

This project addresses the core mission of Versus Arthritis Versus Arthritis has a mission to 'push back against arthritis' and to develop breakthrough treatments.

By figuratively, and literally, pushing back against hand arthritis, the new joint distraction orthosis delivers potentially disease modifying treatment for the first time.

The outcome of this study will be a distraction orthosis ready for clinical evaluation and commercialisation At the end of this study, the distraction orthosis will be at a mature design stage.

It will have data from an IDEAL stage 2a clinical study and bioengineering assessment that supports further evaluation in a large scale trial. It will have been largely de-risked and therefore an attractive proposition for industry to commercialise.