Efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the RESTORE trial protocol

Table 1 SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) diagram of enrolment, interventions and assessments for the RESTORE trial

Timepoint			Study period
	Enrolment	Baseline	Injection 1	Injection 2	Injection 3	Post-allocation			Close-out
	-t₁		0	1w	2w	2 m	6 m	9 m	12 m
Enrolment:
Eligibility screen	X
Informed consent	X
Allocation		X
Interventions:
Platelet rich plasma			X	X	X
Saline			X	X	X
Assessments:
Primary outcomes
Average overall knee pain severity		X				X	X	X	X
Medial tibial cartilage volume		X							X
Secondary outcomes
Walking pain severity		X				X			X
KOOS		X
ICOAP		X
Participant global ratings of change						X			X
AQoL-8D		X				X	X	X	X
MOAKS sub-scores		X							X
BML and cartilage defects score		X							X
Other measures
Drug/supplement use		X				X			X
Cytokines and growth factors			X	X	X
Number of injections			X	X	X
Adverse events, co-interventions						X			X
Success of blinding					X
Descriptive measures
Weight, height, BMI		X							X
Age, gender, symptom duration, x-ray severity, knee alignment, employment, symptom laterality, other symptoms, treatment expectation, PainDETECT, PASE, knee effusion		X
Health economic data
QALYs, cost-effectiveness ratio, WHOHPQ		X				X	X	X	X

ICOAP Intermittent and Constant Osteoarthritis Pain, KOOS Knee Injury and Osteoarthritis Outcome Score, AQOL-8D Assessment of Quality of Life Instrument (8D version), MOAKS Magnetic resonance imaging OA Knee Score, BMI Body mass index, PASE Physical Activity Scale for the Elderly, QALYs Quality Adjusted Life Years, WHO HPQ World Health Organisation Health Performance Questionnaire

ISSN: 1471-2474