WHITE1 Clinical Trial

Zero (0%) re-operation rate for X-Bolt vs 6.8% with SHS in unstable A2 and A3 fractures

The Bone & Joint Journal 2016 May; 98(5):686-9.

Single-centre study (University Hospital of Coventry and Warwick, UK)

Surgeons of all grades as operators (pragmatic, real-world situation)

12-month follow-up; assessments at 4 weeks, 4 months and 12 months

Key part of methodology was to maximise recruitment of those patients who would be expected to have a high reoperation rate:

• A1 (simple) fractures excluded as known low reoperation rate
• Patients with dementia included (ethics approved) as known to have a greater reoperation rate

Results

• Zero (0%) reoperation rate with X-Bolt
• 3/44 (6.8%) reoperation rate with SHS
• No significant difference in EQ-5D
• A definitive trial to find a clinically importance difference in EQ-5D would require 964 participants based on the data from this study
• The WHITE4 commenced in Q2 2016 as this definitive trial