Table 1.
RACER-Hip SPIRIT outcomes and assessment schedule
| Time point | Study period | ||||||||||
| Enrolment | Baseline (pre-allocation) |
Allocation | Post-allocation | ||||||||
| −t2 | −t1 | 0 | t1 Days 1,2,3 |
t2 6 weeks |
t3 3 months |
t4 6 months |
t5 12 months |
t6 24 months |
t7 5 years |
t8 10 years |
|
| Enrolment | |||||||||||
| Eligibility screen | |||||||||||
| Informed consent | ✓ | ||||||||||
| Randomisation | n=378 | ✓ | |||||||||
| Interventions | |||||||||||
| Robotic THR | n=189 | ||||||||||
| Conventional THR | n=189 | ||||||||||
| Assessments | |||||||||||
| Primary outcome | FJS | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| Secondary outcomes | Pain intensity (NRS 11 point) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Opioid usage | ✓ | ||||||||||
| Estimated blood loss | ✓ | ||||||||||
| Time to discharge | ✓ | ||||||||||
| Oxford Hip Score | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| EQ-5D-5L | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| Post operative CT measures and process outcomes | ✓ | ||||||||||
| Resource use | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
| Participant satisfaction | ✓ | ||||||||||
EQ-5D-5L, EuroQol five dimensions; FJS, Forgotten Joint Score; NRS, Numerical Rating Scale; RACER-Hip, Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial for Hips; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; t, time point; THR, total hip replacement.