Efficacy of intra-articular injection of allogeneic platelet-rich plasma for knee osteoarthritis combined with hematologic blood dyscrasias with platelet dysfunction: protocol of a randomized, double-blind, placebo-controlled trial

Table 1 Schedule of enrolment, interventions and assessments

Time point			Study period
	Enrolment	Baseline	Injection	Post-allocation			Close-out
			1	1 M	3 M	6 M	12 M
Enrolment
Eligibility screen	×
Informed consent	×
Allocation		×
Interventions:
Platelet rich plasma			×
Saline			×
Assessments:
Primary outcomes
^aWOMAC score		×		×	×	×	×
Secondary outcomes
^bVAS		×		×	×	×	×
Lysholm score		×		×	×	×	×
^cSF-36		×		×	×	×	×
MRI analysis		×					×
Other measures
Drug/supplement use		×		×	×	×	×
Platelets and leukocytes counts, VEGF and TGF-β			×
Number of injections			×
Adverse events			×	×	×	×	×
Success of blinding			×
Descriptive measures
Weight, height, BMI, Kellgren and Lawrence grade, Age, gender, duration of symptoms		×
Injection site, Complications			×

^aWOMAC score, The Western Ontario and McMaster Universities Osteoarthritis Index; ^bVAS, visual analogue scale; ^cSF-36, the short-form 36 item health survey questionnaire

ISSN: 1471-2474