The Knee-Fix study: study protocol for a randomised controlled trial evaluating cemented and cementless components in total knee arthroplasty

Table 1 Patient evaluation schedule for Knee-Fix study: an RCT evaluating cemented vs. cementless total knee arthroplasty

	Study period
	Enrolment	Allocation	Post-allocation				Close-out
Timepoint	−t₁ (−2 months)	0	t₁ (6–12 weeks)	t₂ (12 months)	t₃ (24 months)	t₄ (5 years)	t₅ (10 years)
Enrolment:
Eligibility screen	X
Informed consent	X
*Demographics, medical history*	X
Allocation		X
Intervention:
*Cemented TKA*		X
*Cementless TKA*		X
Assessments:
*AP, ML and Skyline X-rays*	X	X	X^a		X	X	X
*Oxford Knee Score*	X		X	X	X	X	X
*International Knee Society System*	X				X	X	X
*Forgotten Joint Score-12*					X	X	X
*EQ-5D-5L*	X				X	X	X
*VAS Pain*	X		X	X	X	X	X
*Patient Satisfaction score*				X	X	X	X
*Net Promoter Score*				X	X	X	X

AP Anterior-posterior, EQ-5D-5L Euroqol 5 dimensions, ML Medio-lateral, TKA total knee arthroplasty, VAS Visual analogue scale
^a6–12 week X-rays only for patients with inadequate immediate post-op images

ISSN: 1745-6215