Table 1 Participant timeline
Outpatient Clinic: Screening (MRI) Study information provided in writing | |
Baseline visit: Informed consent Baseline study MRI Randomization Baseline PROMs | |
Group A: IMPACT | Group B: Control (nonsurgical) |
Preoperative screening Anti-HLA antibodies | 3 months after inclusion PROMs Check-up study physician (by telephone) |
Surgery/1 day postoperative Blood chemistry (CRP, ESR, Leucocytes) Visit physical therapist Check-up rheumatologist Check-up study physician | 6 months after inclusion PROMs Check-up study physician MRI |
1 week postoperative Blood chemistry (CRP, ESR, Leucocytes) Check-up rheumatologist Check-up study physician | 9 months after inclusion PROMs |
4 weeks postoperative Blood chemistry (CRP, ESR, Leucocytes, anti-HLA antibodies) Check-up rheumatologist Check-up study physician | In case of cross-over to IMPACT: follow group A In case nonsurgical treatment is continued: 12 months after inclusion: PROMs |
3 months postoperative Check-up study physician (by telephone) PROMs | 18 months after inclusion: PROMs MRI |
6 months postoperative Check-up study physician PROMs MRI | |
9 months postoperative PROMs | |
12 months postoperative Check-up study physician PROMs | |
18 months postoperative Check-up study physician PROMs MRI | |