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

Table 1 The schedule of enrollment, interventions, and assessments

	Study period
	Enrollment	Allocation	Post-allocation			Close-out
Timepoint^a	-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

^a-t₁ = baseline, t₁ = operative treatment, t₂ = postoperative at 2–3 months, t₃ = at 1 year, t₄ = at 2 years

ISSN: 1471-2474