A prospective multi-site registry study of a specific protocol of autologous bone marrow concentrate for the treatment of shoulder rotator cuff tears and osteoarthritis

Figures & data

Table 1 Baseline characteristics and differences between osteoarthritis and rotator cuff groups

	Osteoarthritis			Rotator cuff disorder			P-value
	N	Mean	SD	N	Mean	SD
Age	34	52.1	14.3	81	59.5	11.9	0.015*
BMI	29	25.3	2.9	67	26.6	4.7	0.271
Cell count ×10^8	24	3.85	2.15	57	4.99	3.37	0.116
	N	%		N	%
Sex	34			81			0.137
Male	27	79.4		53	65.4
Female	7	20.6		28	34.6

Notes: N, observations with available data.

* is statistically significant. P-values were calculated using the Wilcoxon rank sum test for age and BMI and chi-square test for the sex variable. Cell count, number of nucleated cells injected.

Abbreviations: SD, standard deviation; BMI, body mass index.

Table 2 Pre-treatment and post-treatment clinical scales, changes from the baseline, and mean follow-up periods in months for the study population

Variable	N	Mean	SD	P-value
DASH
Pre-treatment	40	36.1	19.8	–
Post-treatment	40	17.1	12.6	–
Difference	40	−19	18.8	<0.001*
Follow-up period	40	7.1	6.6	–
NPS
Pre-treatment	55	4.3	2.2	–
Post-treatment	55	2.4	2.1	–
Difference	55	−1.9	2.4	<0.001*
Follow-up period	55	8.3	7.8	–
Improvement rating score
Post-treatment	85	48.8	44	–
Follow-up period	85	11.2	10	–

Notes: N, observations with available data.

* is statistically significant. P-values were calculated for intra-group differences using the Wilcoxon signed-rank test.

Abbreviations: SD, standard deviation; DASH, disabilities of the arm, shoulder and hand scale; NPS, numeric pain scale.

Table 3 Comparison between osteoarthritis and rotator cuff groups: changes in DASH, NPS, and reported subjective percentage improvement rating score

	Osteoarthritis			Rotator cuff			P-value
	N	Mean	SD	N	Mean	SD
Change in DASH	10	−18.7	11.2	30	−19.1	20.9	0.963
Change in NPS	14	−1.6	2.1	41	−2.1	2.5	0.308
Improvement rating score	24	50.4	34.8	61	48.1	47.4	0.872

Notes: N, observations with available data. P-values were calculated for inter-group differences using the Wilcoxon rank sum test.

Abbreviations: SD, standard deviation; DASH, disabilities of the arm, shoulder and hand scale; NPS, numeric pain scale.

Table 4 The effect of baseline score, diagnosis of rotator cuff injury, age, and BMI on outcomes

	N	Coefficient (β)	SE	P-value
Change in DASH score	37
Baseline score		−0.65	0.11	<0.001*
Disease type (rotator cuff)		−0.74	4.72	0.877
Age		0.28	0.18	0.136
BMI		−0.18	0.64	0.777
Sex (male)		5.19	5.15	0.321
Change in NPS score	52
Baseline score		−0.51	0.13	<0.001*
Disease type (rotator cuff)		0.14	0.66	0.835
Age		−0.02	0.02	0.494
BMI		−0.08	0.08	0.319
Sex (male)		0.74	0.67	0.275
Improvement rating score	76
Disease type (rotator cuff)		−9.50	12.42	0.447
Age		−0.24	0.43	0.589
BMI		−0.17	1.55	0.915
Sex (male)		−25.18	12.18	0.042*

Note:

* Statistically significant at P≤0.05. Cell count, number of nucleated cells injected.

Abbreviations: BMI, body mass index; SE, standard error; DASH, disabilities of the arm, shoulder, and hand scale; NPS, numeric pain scale; N, number of observations.

Table 5 Multivariate regression models including cell count as a predictive variable

	N	Coefficient (β)	SE	P-value
Change in DASH score	24
Baseline score		−0.54	0.23	0.034*
Disease type (rotator cuff)		−5.19	9.02	0.572
Age		0.60	0.29	0.058
BMI		−0.54	1.22	0.662
Sex (male)		4.36	8.97	0.633
Cell count		0.76	2.07	0.716
Change in NPS score	36
Baseline score		−0.54	0.17	0.004*
Disease type (rotator cuff)		0.17	0.99	0.863
Age		−0.02	0.03	0.546
BMI		−0.12	0.14	0.390
Sex (male)		1.09	1.22	0.380
Cell count		−0.05	0.17	0.764
Improvement rating score	56
Disease type (rotator cuff)		−9.01	17.00	0.598
Age		−0.53	0.58	0.364
BMI		−1.47	2.13	0.494
Sex (male)		−23.54	17.79	0.192
Cell count		1.90	3.01	0.530

Notes:

* Statistically significant at P≤0.05. Cell count = (×10⁸). Cell count, number of nucleated cells injected.

Abbreviations: SE, standard error; DASH, disabilities of the arm, shoulder and hand scale; BMI, body mass index; NPS, numeric pain scale; N, number of observations.