Surgery versus Conservative OsteOarthritis of Thumb Trial (SCOOTT). An RCT to determine clinical and cost effectiveness of treating arthritis of the base of the thumb, with or without surgery, and to determine the clinical and cost effectiveness of trapeziectomy versus base of thumb joint replacement

Research summary

Basal thumb osteoarthritis (BTOA) is a common condition that affects 21% of the population by the age of 40 and 45% by the age of 80. BTOA causes significant problems in this large population with symptoms including pain, tenderness and stiffness. There are a variety of non-surgical and surgical treatments available for BTOA. If non-surgical treatment fails then surgical options can be offered (trapeziectomy and carpometacarpal joint replacement (CMCJR)). However there is a lack of high quality evidence comparing these currently used treatment options. Current evidence suggests that there is wide variation of non-surgical treatment being delivered to patients across the UK. Trapeziectomy is the most commonly performed surgical procedure for BTOA, however, CMCJR is now being increasingly used in the UK. The trial will compare three treatment options for BTOA; (1) Enhanced Non-surGical mAnaGEment for BTOA (ENGAGE) package. This is a specialist hand therapist led package which includes education, hand exercises, and may include hand splints and joint injections. Self management resources for both physical therapy and psychological pain coping skills, are provided to empower participants to self-manage their BTOA. (2) Trapeziectomy - this is the surgical removal of the arthritic trapezium bone at the base of the thumb which improves pain by preventing the arthritic joints rubbing against each other. (3) Carpometacarpal joint replacement (CMCJR) - this is the surgical removal of the carpometacarpal joint at the base of the thumb and replacement of that joint with a prosthetic joint . In this randomised controlled trial, we aim to answer two important questions: Is surgery (trapeziectomy and CMCJR) superior to enhanced non-surgical management (the ENGAGE therapy package)? Is CMCJR surgery as good as trapeziectomy surgery? 656 adults (aged over 16), referred to secondary care and who have symptomatic BTOA will be invited to take part in the study. Surgeons will review the patient’s condition to ensure that they meet the trial entry criteria. Patients will be provided with information about all three treatments; the information provided to patients has been reviewed by a patient panel to ensure that they explain the study clearly. All participants will be enrolled in the trial for 18 months. We will assess participants at the start of the study, then at 6 weeks, 3 months and 6 months after their treatment and at 6, 12 and 18 months after their enrolment into the study. At the trial assessments, we will record pain levels, how well the participant can use their hand, hand movements and strength, and ask about any problems relating to their treatment. Participants will complete questionnaires about their hand that our patient panel endorsed as being appropriate. Some participants and surgeons involved in the study will be invited to take part in an interview to better understand their experience of the trial and of receiving and delivering the interventions in practice. We will also find out the cost of the three treatments relative to their benefits to find out which is better value for money for the NHS.

Principal Investigator

Mr Benjamin Dean

Contact us

Email: gail.lang@ndorms.ox.ac.uk

IRAS number

336574