Table 4.

Percentage of patients achieving a successful clinical and radiologic treatment response at 12 months (full analysis set)

	Study group			Control group			Absolute difference (study group minus control)
	n	% (n)	95% CI	n	% (n)	95% CI	Value (95% CI)	p valuea
Clinical success	21	81 (17)	58 to 95	23	70 (16)	47 to 87	-0.11 (-0.37 to 0.14)	0.38
Radiologic success	21	76 (16)	53 to 92	23	78 (18)	56 to 93	0.02 (-0.23 to 0.27)	0.87

Study group: patients treated with core decompression and implantation of autologous osteoblastic cells. Control group: patients treated with core decompression and placebo implantation. Data at 12 months were obtained for 44 patients included in the interim analysis and after applying the rules for missing data imputation. Clinical success was defined as 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). Radiologic success was considered a 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.

n – number of evaluable patients; % (n) – percentage (number) of patients with a response; CI – confidence interval.