The effectiveness and safety of demineralized bone matrix in limbs bone grafting: a systemicreview and meta-analysis

doi:10.3877/cma.j.issn.2096-0263.2018.04.009

Abstract

Abstract:

Objective

To study the efficacy of decalcified bone matrix (DBM) in limb bone grafting surgery. A systematic review and meta-analysis of all available data was conducted to evaluate the effectiveness and safety of DBM as a bone graft substitute in limb limb grafting.

Methods

Literature research was performed in the PubMed, MEDLINE, EMBASE and the Cochrane Library. The application of DBM in bone grafting of limbs was retrieved and selected according to the literature inclusion criteria. Focus on selecting articles that can be extracted and meta-analyzed.

Results

Forty-four studies met the inclusion criteria, including three randomized controlled trials, 27 case series studies, and 14 case-control studies. None of the studies reported the destruction or displacement of DBM as a fusion site of the graft.

Conclusions

A series of case studies suggest that the use of Allomatrix DBM as a surrogate for autologous bone grafts has an unacceptably high risk of complications. The results of the remaining 43 studies reported that DBM was non-inferior compared to autologous bone and other bone graft substitute materials. According to the follow-up report of patients, the fusion rate and safety of DBM as a substitute material for bone graft can be considered. It is guaranteed, but the amount and quality of evidence in this area is very limited.

Key words: Demineralized bone matrix, Bone transplanation, Meta-analysis

Kunchi Hua, Jiangtao Feng, Xionggang Yang, Dengxing Lun, Feng Wang, Yongheng Liu, Li Yang, Hao Zhang, Yongcheng Hu. The effectiveness and safety of demineralized bone matrix in limbs bone grafting: a systemicreview and meta-analysis[J]. Chinese Journal of Geriatric Orthopaedics and Rehabilitation(Electronic Edition), 2018, 04(04): 235-246.

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Figures/Tables 9

References 48

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作者	年份	类型	人数	病例数	疾病类型	复合物类型	愈合数	愈合率(愈合数/病例数)	随访（月）
Bruce H.	2006	系列	41	41	nonunion	AlloMatrix +同种异体松质骨	20	48.8%	12
Pingal D	2015	系列	22	22	nonunion	DBM	19	79.2%	24
Travis M	2016	系列	25	34	股骨头骨骺滑脱	Grafton DBM+自体骨	22	64.7%	48
Jason EH	2011	系列	31	31	股骨头坏死	Grafton DBM	18	58.1%	32.6
Yang SH	2008	系列	31	33	股骨头坏死	DBM+自体骨	31	93.9%	38
Wang BL	2010	系列	110	138	股骨头坏死	DBM+自体骨	94	68.1%	25.37
Nguyen V	2009	系列	7	7	骨缺损	AlloMatrix	5	71.4%	至少3.5
Ryan GM	2009	系列	7	8	骨折	Grafton DBM	8	100%	25.75
Craig RL	2016	系列	25	25	骨折	骨髓+DBM	25	100%	2
Kenneth JH	2011	系列	8	8	骨折	骨髓+DBM	8	100%	29
D.Whiteman PT	1993	系列	20	20	骨缺损	DBM	20	100%	20
Kwok TY	2015	系列	3	3	骨肿瘤	DBM	3	100%	17
Mostafa AA	2014	系列	62	62	骨缺损	DBM+磷酸三钙	58	93.5	18.4
Lynn AC	1996	系列	42	42	踝关节融合	DBM+骨髓	39	64.3%	27
Ross MW	2003	系列	76	76	骨肿瘤；nonunion	Allomatrix	67	88.2%	6.5
Wilkins RM	2003	系列	66	69	nonunion	DBM+骨髓	61	88.4%	21.7
Ji WF	2008	系列	87	103	股骨头坏死	DBM+骨髓	78	75.7%	26
Cynthia MK	2004	系列	15	15	骨肿瘤	Allomatrix	14	93.3%	至少6
M Neel	2003	系列	9	9	骨肿瘤	Allomatrix+骨髓	8	88.9%	至少4
G Etienne	2004	系列	20	20	髋臼翻修	DBM+自体骨	18	90.0%	27
Tiedeman JJ	1995	系列	39	39	骨缺损	DBM+骨髓	30	76.9%	NS
Anastasios DK	2007	系列	9	9	骨囊肿	DBM+骨髓	9	100%	77
Kenneth RG	2017	系列	51	51	骨囊肿	DBM+骨髓	35	68.6%	34
Hwan SC	2012	系列	25	25	骨囊肿	DBM	23	92.0%	23.9
Anastasios DK	2005	系列	19	19	骨囊肿	DBM+骨髓	19	100%	28
Bruce TR	2002	系列	23	23	骨囊肿	DBM+骨髓	23	100%	50
Anthony DS	2008	系列	34	34	骨囊肿	DBM+骨髓	17	50.0%	87.6
Agostino PD	2013	RCT	24	24	骨折	AlloMatrix	NS	NS	15
?	?	?	26	26	骨折	无	NS	NS	14.2
Meir L	2013	RCT	12	12	骨折	DBM+间充质干细胞+富血小板血浆	12	100%	12
?	?	?	12	12	骨折	无	9	75.0%	12
Dante D	2011	RCT	9	9	胫骨截骨	DBM+镁羟基磷灰石	NS	NS	12
?	?	?	13	13	胫骨截骨	镁羟基磷灰石	NS	NS	12
?	?	?	9	9	胫骨截骨	冻干骨片	NS	NS	12
Oliver P	2009	对照	10	10	nonunion	DBM	10	100%	41.2
?	?	?	10	10	nonunion	自体骨	8	80%	56.6
Yong F	2011	对照	24	24	股骨头坏死	OsteoSet?2 DBM	20	83.3%	26
?	?	?	24	24	股骨头坏死	自体骨	19	79.2%	26
Noratep K	2016	对照	9	9	骨折	DBM	4	44.4%	18
?	?	?	9	9	骨折	无	7	77.8%	31.25
作者	年份	类型	人数	病例数	疾病类型	复合物类型	愈合数	愈合率(愈合数/病例数)	随访（月）
Edgardo RRC	2015	对照	10	10	骨折	DBM+骨髓	8	80.0%	18
?	?	?	10	10	骨折	无	7	70.0%	18
Christian H	2006	对照	33	33	骨折	DBM	32	97.0%	20.4
?	?	?	45	45	骨折	自体骨	45	100%	32.8
Christopher B	2006	对照	33	33	骨折	DBM	28	84.8%	22.4
?	?	?	11	11	骨折	无	11	100%	22.4
June HK	2011	对照	28	27	骨折	DBM	24	88.9%	17.3
?	?	?	28	28	骨折	注射用硫酸钙	24	85.7%	17.3
Ippokratis H	2011	对照	10	10	骨缺损	DBM	NS	NS	NS
?	?	?	22	22	骨缺损	自体骨	NS	NS	NS
?	?	?	11	11	骨缺损	无	NS	NS	NS
S. Cheung	2003	对照	15	15	骨折	Orthoblast DBM	15	100%	12
?	?	?	13	13	骨折	Grafton DBM	9	69.2%	12
David BT	2003	对照	26	26	踝关节融合	Orthoblast DBM	24	92.3%	至少12
?	?	?	37	37	踝关节融合	Grafton DBM	32	86.5%	至少12
M. Tricot	2017	对照	30	45	踝关节融合	DBM+自体骨	37	82.2%	17
?	?	?	52	70	踝关节融合	DBM+同种异体骨	59	84.3%	12.5
Ronald WL	2006	对照	10	10	骨折	DBM+骨髓	10	100%	20.9
?	?	?	8	8	骨折	自体骨	5	62.5%	19.4
Il-Hyung P	2008	对照	9	10	骨囊肿	DBM+骨髓	8	80.0%	34
?	?	?	10	13	骨囊肿	无	9	69.2%	62.3
Claudia DB	2010	对照	41	41	骨囊肿	DBM+骨髓	27	65.9%	20
?	?	?	143	143	骨囊肿	激素	54	37.8%	48

作者	年份	类型	人数	病例数	疾病类型	复合物类型	愈合数	愈合率(愈合数/病例数)	随访（月）
Bruce H.	2006	系列	41	41	nonunion	AlloMatrix +同种异体松质骨	20	48.8%	12
Pingal D	2015	系列	22	22	nonunion	DBM	19	79.2%	24
Travis M	2016	系列	25	34	股骨头骨骺滑脱	Grafton DBM+自体骨	22	64.7%	48
Jason EH	2011	系列	31	31	股骨头坏死	Grafton DBM	18	58.1%	32.6
Yang SH	2008	系列	31	33	股骨头坏死	DBM+自体骨	31	93.9%	38
Wang BL	2010	系列	110	138	股骨头坏死	DBM+自体骨	94	68.1%	25.37
Nguyen V	2009	系列	7	7	骨缺损	AlloMatrix	5	71.4%	至少3.5
Ryan GM	2009	系列	7	8	骨折	Grafton DBM	8	100%	25.75
Craig RL	2016	系列	25	25	骨折	骨髓+DBM	25	100%	2
Kenneth JH	2011	系列	8	8	骨折	骨髓+DBM	8	100%	29
D.Whiteman PT	1993	系列	20	20	骨缺损	DBM	20	100%	20
Kwok TY	2015	系列	3	3	骨肿瘤	DBM	3	100%	17
Mostafa AA	2014	系列	62	62	骨缺损	DBM+磷酸三钙	58	93.5	18.4
Lynn AC	1996	系列	42	42	踝关节融合	DBM+骨髓	39	64.3%	27
Ross MW	2003	系列	76	76	骨肿瘤；nonunion	Allomatrix	67	88.2%	6.5
Wilkins RM	2003	系列	66	69	nonunion	DBM+骨髓	61	88.4%	21.7
Ji WF	2008	系列	87	103	股骨头坏死	DBM+骨髓	78	75.7%	26
Cynthia MK	2004	系列	15	15	骨肿瘤	Allomatrix	14	93.3%	至少6
M Neel	2003	系列	9	9	骨肿瘤	Allomatrix+骨髓	8	88.9%	至少4
G Etienne	2004	系列	20	20	髋臼翻修	DBM+自体骨	18	90.0%	27
Tiedeman JJ	1995	系列	39	39	骨缺损	DBM+骨髓	30	76.9%	NS
Anastasios DK	2007	系列	9	9	骨囊肿	DBM+骨髓	9	100%	77
Kenneth RG	2017	系列	51	51	骨囊肿	DBM+骨髓	35	68.6%	34
Hwan SC	2012	系列	25	25	骨囊肿	DBM	23	92.0%	23.9
Anastasios DK	2005	系列	19	19	骨囊肿	DBM+骨髓	19	100%	28
Bruce TR	2002	系列	23	23	骨囊肿	DBM+骨髓	23	100%	50
Anthony DS	2008	系列	34	34	骨囊肿	DBM+骨髓	17	50.0%	87.6
Agostino PD	2013	RCT	24	24	骨折	AlloMatrix	NS	NS	15
?	?	?	26	26	骨折	无	NS	NS	14.2
Meir L	2013	RCT	12	12	骨折	DBM+间充质干细胞+富血小板血浆	12	100%	12
?	?	?	12	12	骨折	无	9	75.0%	12
Dante D	2011	RCT	9	9	胫骨截骨	DBM+镁羟基磷灰石	NS	NS	12
?	?	?	13	13	胫骨截骨	镁羟基磷灰石	NS	NS	12
?	?	?	9	9	胫骨截骨	冻干骨片	NS	NS	12
Oliver P	2009	对照	10	10	nonunion	DBM	10	100%	41.2
?	?	?	10	10	nonunion	自体骨	8	80%	56.6
Yong F	2011	对照	24	24	股骨头坏死	OsteoSet?2 DBM	20	83.3%	26
?	?	?	24	24	股骨头坏死	自体骨	19	79.2%	26
Noratep K	2016	对照	9	9	骨折	DBM	4	44.4%	18
?	?	?	9	9	骨折	无	7	77.8%	31.25
作者	年份	类型	人数	病例数	疾病类型	复合物类型	愈合数	愈合率(愈合数/病例数)	随访（月）
Edgardo RRC	2015	对照	10	10	骨折	DBM+骨髓	8	80.0%	18
?	?	?	10	10	骨折	无	7	70.0%	18
Christian H	2006	对照	33	33	骨折	DBM	32	97.0%	20.4
?	?	?	45	45	骨折	自体骨	45	100%	32.8
Christopher B	2006	对照	33	33	骨折	DBM	28	84.8%	22.4
?	?	?	11	11	骨折	无	11	100%	22.4
June HK	2011	对照	28	27	骨折	DBM	24	88.9%	17.3
?	?	?	28	28	骨折	注射用硫酸钙	24	85.7%	17.3
Ippokratis H	2011	对照	10	10	骨缺损	DBM	NS	NS	NS
?	?	?	22	22	骨缺损	自体骨	NS	NS	NS
?	?	?	11	11	骨缺损	无	NS	NS	NS
S. Cheung	2003	对照	15	15	骨折	Orthoblast DBM	15	100%	12
?	?	?	13	13	骨折	Grafton DBM	9	69.2%	12
David BT	2003	对照	26	26	踝关节融合	Orthoblast DBM	24	92.3%	至少12
?	?	?	37	37	踝关节融合	Grafton DBM	32	86.5%	至少12
M. Tricot	2017	对照	30	45	踝关节融合	DBM+自体骨	37	82.2%	17
?	?	?	52	70	踝关节融合	DBM+同种异体骨	59	84.3%	12.5
Ronald WL	2006	对照	10	10	骨折	DBM+骨髓	10	100%	20.9
?	?	?	8	8	骨折	自体骨	5	62.5%	19.4
Il-Hyung P	2008	对照	9	10	骨囊肿	DBM+骨髓	8	80.0%	34
?	?	?	10	13	骨囊肿	无	9	69.2%	62.3
Claudia DB	2010	对照	41	41	骨囊肿	DBM+骨髓	27	65.9%	20
?	?	?	143	143	骨囊肿	激素	54	37.8%	48

疾病类型	研究数（个）	患者（例）	愈合率
股骨头坏死	5（11.1%）	335	73.30%
骨肿瘤	13（28.8.%）	308	80.50%
不愈合	5（11.1%）	177	78.50%
骨折	11（24.4%）	200	91.50%
踝关节融合	3（6.67%）	220	86.80%

疾病类型	研究数（个）	患者（例）	愈合率
股骨头坏死	5（11.1%）	335	73.30%
骨肿瘤	13（28.8.%）	308	80.50%
不愈合	5（11.1%）	177	78.50%
骨折	11（24.4%）	200	91.50%
踝关节融合	3（6.67%）	220	86.80%

移植物类型	研究数（个）	愈合数	样本量	愈合率
DBM	8（17.0%）	135	149	90.6%
Grafton?DBM	4（8.5%）	67	89	75.2%
Orthoblast?DBM	2（4.3%）	39	41	95.1%
AlloMatrix?DBM	7（14.9%）	166	205	80.9%
DBM+自体骨	5（10.6%）	202	270	74.8%
DBM+骨髓	16（34.0%）	407	503	80.9%
DBM+异体骨	1（2.1%）	59	70	84.3%
OsteoSet?DBM	1（2.1%）	26	30	86.6%
DBM+间充质干细胞+富血小板血浆	1（2.1%）	12	12	100%
DBM+磷酸三钙	1（2.1%）	58	62	93.5%
DBM+镁羟基磷灰石	1（2.1%）	5	9	55.5%

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