Skip to main content

Table 1 The schedule of enrollment, interventions, and assessments

From: Functional outcome of total knee replacement: a study protocol for a prospective, double-blinded, parallel-group randomized, clinical controlled trial of novel, personalized and conventional implants

  Study period
Enrollment Allocation Post-allocation Close-out
Timepointa -t 1 0 t 1 t 2 t 3 t 4
Enrollment
 Eligibility screen X      
 Informed consent X      
 Medical history X      
 Allocation   X     
Interventions:
 PFC CR Total knee replacement    X    
 NexGen CR Total knee replacement    X    
 Persona CR Total knee replacement    X    
Assessments:
 X-ray X    X   
 Pain sensitivity (PCS) X      
 Pain inventory (BPI) X      
 Oxford Knee Score (OKS) X    X X X
 15D X    X X X
 Forgotten Joint Score (FJS) X    X X X
 UCLA activity score X    X X X
 Surgeon visit X      
 Physiotherapist visit X    X X X
  1. a-t1 = baseline, t1 = operative treatment, t2 = postoperative at 2–3 months, t3 = at 1 year, t4 = at 2 years