Table 3.

Percentage of patients achieving successful composite treatment response at 12 and 24 months (full analysis set)

Overall success	Study group		Control group		Relative Risk (95% CI)	p valuea
	n	% (n)	n	% (n)
12 months	21	67 (14)	23	65 (15)	1.02 (0.67 to 1.56)	0.92
24 monthsb	23	61 (14)	26	69 (18)	0.88 (0.58 to 1.33)	0.54

Study group: patients treated with core decompression and implantation of autologous osteoblastic cells. Control group: patients treated with core decompression and placebo implantation. Twelve-month data were obtained for 44 patients included in the interim analysis and after applying the rules for missing data imputation. Data at 24 months were obtained for 49 patients included in the primary endpoint analysis (after terminating the study) and after applying the rules for missing data imputation. Overall success was defined as a composite of clinical success (improvement in pain from baseline by at least the minimum clinically important difference [10 mm], assessed using the WOMAC VA3.1 [VAS subscale score of the treated hip]; patients with a baseline WOMAC VA3.1 pain subscale score < 10 mm were considered responders if the score for the treated hip was between 0 and 4 mm) and radiologic success (lack of progression to fracture [≥ ARCO Stage III] in the treated hip, assessed at the studied timepoints using radiographs). The full analysis set was defined as a modified intention-to-treat cohort that included all randomized and treated patients, with a baseline value available of the ARCO stage and the WOMAC VA3.1 pain subscale score, and at least one post-baseline value available of both the ARCO stage and the WOMAC VA3.1 pain subscale score.

^aPearson chi-square test or Fisher exact test.

^bPrimary study endpoint.

n = number of evaluable patients; % (n) = percentage (number) of patients achieving overall success; CI = confidence interval.