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Table 1 Summary of outcomes and assessment schedule

From: Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial

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

  1. Adverse events can be reported throughout follow-up (e.g., clinical events form, follow-up questionnaires) and in the final readmission check-list
  2. a Clinical assessment appointment for participants randomised to rehabilitation requiring reassessment due to continued problems with instability
  3. b Only KOOS4 (Pain, Symptoms, Function in sport and recreation and knee related Quality of life subscales)
  4. c ACL-QoL – only questions 1–5, 11 and 12
  5. d Questions about your treatment and your health – 1 question