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. 2020 May 14;21:405. doi: 10.1186/s13063-020-04298-y

Table 1.

Summary of outcomes and assessment schedule

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

Adverse events can be reported throughout follow-up (e.g., clinical events form, follow-up questionnaires) and in the final readmission check-list

a Clinical assessment appointment for participants randomised to rehabilitation requiring reassessment due to continued problems with instability

b Only KOOS4 (Pain, Symptoms, Function in sport and recreation and knee related Quality of life subscales)

c ACL-QoL – only questions 1–5, 11 and 12

d Questions about your treatment and your health – 1 question