Objectives: Following a craniectomy for TBI or an MCA infarct, a cranioplasty is usually performed between 6-12 months later with the main aims of restoring skull integrity and cosmesis. The number of early cranioplasties is increasing; however, the timing of ‘early and late’ remains varied and debated 1,2 . The evidence base is expanding but there is a lack of high-quality prospective studies. Moreover, the definitions of neurological recovery vary significantly. A randomised trial will help answer the question around optimal timing of cranioplasty. A core outcome set (COS) will hopefully standardise the endpoints that should be measured and will facilitate cross-study comparisons.
A single-centre, pilot, prospective, parallel group randomised trial with 1:1 allocation ratio to early vs late cranioplasty of participants 16 yo. The Cranioplasty COS is a mixed methods study divided into 2 phases: Phase 1 is information gathering of current outcomes used in cranioplasty studies. Phase 2 is the Delphi study and formation of the core outcome set. Alongside is a phenomenological qualitative study exploring the issues and hurdles that affect the patients quality of life before and after a cranioplasty.
Recruitment is for 12 months from April 2019. To date, 12 patients have been screened, 7 eligible and 6 enrolled (86%). Participants are stratified depending on aetiology. Baseline data at 2 months and further timepoints at 6, 12 and 18 months from craniectomy date. The primary outcome is the GOSE at 6 months.
A cranioplasty has so many different dimensions and although its complications are well documented there is no universal consensus on the optimal time for the operation, and only minimal, inconclusive, evidence base to aid clinicians. This work, hopefully, will help to tackle a few of these issues and help better understand the hurdles and difficulties a patient may face before and after a cranioplasty.
Harry Mee– Rehabilitation Medicine Registrar, Department of Clinical Neurosciences, University of Cambridge & Addenbrooke’s Hospital
Angelos Kolias– Academic Clinical Lecturer, Cambridge University
Gemma Whiting– Cranioplasty Project Co-ordinator, Cambridge University
Fahim Anwar– Rehabilitation Medicine Consultant, Cambridge Foundation NHS Trust
Peter Hutchinson– Professor of Neurosurgery, Cambridge University