Restoring Study PRGF: a randomized clinical trial on plasma rich in growth factors for knee osteoarthritis

Table 2 Prespecified and published primary and secondary outcomes

	Was it included in the original protocol?	Was it included in the final report?	Was it included in the published article?	Were any statistically significant differences found?
Primary outcome
% of patients with a pain decrease >40% in the score in the WOMAC pain subscale	Yes	Yes	No	No
% of patients with a pain decrease >50% in the score in the WOMAC pain subscale	No	No	Yes	Yes
Secondary outcome
% of patients with a pain decrease >40% in the score in the VAS and Lequesne index	Yes	Yes	No	No
% of patients with a function increase ≥30% in the score in Lequesne and WOMAC	Yes	No	No	---
Quality of life (SF-12 questionnaire)	Yes	No	No	---
Degree of joint mobility (goniometer)	Yes	Yes	No	No
Use of acetaminophen	Yes	Yes	Yes	No
Investigational and inflammatory markers. Indicators of cartilage metabolic imbalance	Yes	No	No	---
OMERACT-OARSI responders	No	No	Yes	No
20% decrease in WOMAC pain score	No	No	Yes	No
% change normalized WOMAC pain score	No	No	Yes	No
% change normalized WOMAC stiffness score	No	No	Yes	No
% change normalized WOMAC function score	No	No	Yes	No
% change normalized WOMAC total score	No	No	Yes	No
% change Lequesne index	No	No	Yes	No

VAS Visual Analogue Scale, WOMAC Western Ontario and McMaster Universities Osteoarthritis Index, OMERACT-OARSI Outcome Measures in Rheumatology Clinical Trials-Osteoarthritis Research Society and Health Assessment Questionnaire

ISSN: 1745-6215