The Big BOSS Study
Research type
Research Study
Full title
The Big BOSS Study - The British Orthopaedic SCFE Surgery Study for Severe Stable Slips
IRAS ID
320616
Contact name
Daniel Perry
Contact email
Sponsor organisation
Alder Hey Children’s NHS Foundation Trust
Duration of Study in the UK
4 years, 6 months, 29 days
Research summary
Slipped Capital Femoral Epiphysis or SCFE is a rare condition. SCFE is the most common reason for hip replacement surgery in both adolescence and early adulthood, and the number of children and young people with this condition is increasing.
Imagine the hip like a ball of ice cream (the top of the hip) on an ice cream cone (the thigh bone). As a result of the disease, the ice cream ball could melt and slip a little away from the cone (minor slip) or slip a lot (severe slip) or could just come loose from the cone completely (unstable slip).
For severe slips, doctors currently can choose between two types of operation and it is not clear whether one is better than the other. The first treatment option is inserting a screw through keyhole surgery (stabilising but not putting the ice cream back on the cone) and accepting that the shape of the hip has changed. The second option is to correct the slip through major surgery (stabilising and putting the ice cream back on the cone).
It is planned that 192 patients aged between 8 and 15 years old will participate over a three year period from around 30 hospitals. They will be split fairly into the two treatment options.
How well they can function is the most important thing to find out. Therefore, all children and young people will be followed-up for two-years to monitor function. We will also ask about pain, if they needed any more surgery, educational attendance, any complications, the number of hospital visits, their quality of life and satisfaction with care.
If consented, the participant will be registered with the Non-Arthroplasty Hip Registry (NAHR); (a national UK registry of hip surgery).This will facilitate potential long term follow of trial participants. (Additional approvals and funding required.)REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
23/SW/0047
Date of REC Opinion
25 Apr 2023
REC opinion
Favourable Opinion