Timepoint | Visits | Follow-up – postal/e-mail questionnaire | |||||
---|---|---|---|---|---|---|---|
Screening | Enrolment & Baseline | Intervention | Re-assessmenta | 6 months | 12 months | 18 months | |
Informed consent | X | ||||||
Patient demographics | X | ||||||
Medical history | X | ||||||
Physical examination | Xa | ||||||
MRI (as part of routine practice) | X | ||||||
Eligibility assessment | X | ||||||
Randomisation | X | ||||||
Adverse event reporting⊥ | x | X | X | ||||
Treatment: Operation/rehabilitation | X | ||||||
Questionnaire | |||||||
Knee Injury and Osteoarthritis Outcome Score (KOOS) | X | Xb | Xb | X | |||
Return to activity/ level of sport participation – modified Tegner | X | X | |||||
Health economics – EQ. 5D | X | X | X | X | |||
Complications | X | X | X | ||||
Knee-specific patient-reported outcomes, ACL-QOL | X | Xc | Xc | X | |||
Patient satisfaction | Xd | Xd | X |