A feasibility study of a non-surgical joint distraction orthosis for the treatment of thumb base osteoarthritis
 
Background

Thumb base osteoarthritis is common. There are no disease modifying treatments and surgery is considered as a last resort. Patients and clinicians have prioritised development of evidence based non-surgical treatments for TBOA (JLA for common hand conditions).

There is both pre-clinical and clinical evidence that ‘off-loading’ the forces through an arthritic synovial joint might prevent progression and even reverse the disease process. This has been achieved surgically in several joints, including the knee and first carpometacarpal joint.

The DISTRACT orthosis takes advantage of the anatomy of the hand to deliver joint distraction without the need for surgery. There is a base orthosis with adjustable distraction arms that attach to the thumb tip. A patent has been filed and the technology is available for licensing via Oxford University Innovation.

Development of the orthosis has been supported by grants from the Royal College of Surgeons / Blonde McIndoe Research Foundation, British Association of Plastic, Reconstructive and Aesthetic Surgeons and Versus Arthritis.

The DISTRACT Study

The DISTRACT Study is a first in human cohort study to assess safety and feasibility of a future randomised controlled trial. Alongside the study, there are surveys for patients and clinicians.

Aim of Distract Surveys

The DISTRACT Survey has been designed to gather the opinions from patients and clinicians to help design the first in human study. It will provide important feasibility information.

  • Are patients and clinicians willing to try a distraction orthosis to treat thumb base osteoarthritis?
  • When in the treatment pathway should the DISTRACT splint be used?
  • How long should the DISTRACT splint be worn for?

It will also help us to understand current treatment pathways for thumb base osteoarthritis in the United Kingdom.

Collaborator status

We welcome one local collaborator per hand unit (plastic surgery or orthopaedic parent specialties).

For PubMed-cited collaborator status, each secure completion of:

  • 5 patient surveys
  • 8 clinician surveys (including hand surgeons/trainees, hand therapists, rheumatologists, and GPs).

Registration

Registration to join as a collaborator on the survey is open here

Chief Investigator:

Matthew D Gardiner

Consultant Plastic and Hand Surgeon, Frimley Health NHS Foundation NHS Trust

Honorary Departmental Senior Research Fellow, Kennedy Institute of Rheumatology, NDORMS, University of Oxford

Alice Lee

Trainee Lead for DISTRACT Study

Co-applicants

Prof Tonia Vincent, Kennedy Institute of Rheumatology, NDORMS, University of Oxford

Prof David Beard, SITU, NDORMS, University of Oxford

Prof Karen Baker, NDORMS, University of Oxford

Dr Angela Kedgley, Department of Bioengineering, Imperial College London

Donna Kennedy, Imperial College London

Helen McKenna, Pulvertaft Hand Centre, Derby

Vic Jansen, Pulvertaft Hand Centre, Derby

Lizelle Sander-Danby, Nuffield Orthopaedic Centre, Oxford

FAQs

One. If you are unsure whether someone from your Unit has already registered, please ask locally or get in touch with the steering group (distract.study@gmail.com).

Yes, provided you fulfil one of the respondent categories above.

Once registered, you will be provided with a public survey link, which you can share with patients and clinicians (this requires an internet connection). Alternatively, you can print the survey and manually enter the responses.

Approximately 5 minutes or less.

Ethical approval is not needed for this survey. You will need to gain permission from your local clinical lead for hand surgery and might need other local permissions.

No, unless the consultant is the sole collaborator from a unit.

Funding sources:

Royal College of Surgeons / Blonde McIndoe Research Foundation, British Association of Plastic, Reconstructive and Aesthetic Surgeons and Versus Arthritis