Table 2.
Overview trial procedures
| Procedures/ Assessment | Screening | Randomisation + baseline assessment |
Intervention | Follow-Up Visits | ||||
|---|---|---|---|---|---|---|---|---|
| Visits | V1 | V2 | V3 | V4 | V5 | V6 | V7 | |
| Timing (months) | < 8 weeks after injury |
Baseline < 8 weeks after injury |
4 months post-injury ± 14 days | 7 months post-injury ± 14 days | 12 months post-injury ± 14 days | 24 months post-injury ± 14 days | 36 months post-injury ± 14 days | |
| Enrolment | ||||||||
| Eligibility screen | X | |||||||
| Informed consent | X | |||||||
| Randomisation | X | |||||||
| Intervention | ||||||||
| 1. Rehabilitation + optional delayed surgery | (X)1 | (X)1 | (X)1 | (X)1 | (X)1 | (X)1 | ||
| 2. Immediate ACL reconstruction | X2 | |||||||
| Assessments | ||||||||
| MRI | (retrieved from patient record) | X | X | |||||
| PROMS# | X | X | X | X | X | X | ||
| Adverse events | X | X | X | X | X | |||
| Isokinetic strength | X | X | X | X | X | |||
| Single leg hop for distance | X | X | X | X | ||||
Table 2: Trial procedures for a single patient
# lthe following patient reported outcome measures (PROMS) will be assessed at V2-V7: KOOS, return-to-sport, return-to-work, IPQ-R, TSK, EARS and quality of rehabilitation;1Optional delayed surgery can occur after randomization; 2Immediate ACL reconstruction has to be performed within 12 weeks after injury