Operative and nonoperative treatment of clavicle fractures in adults

Figures & data

Figure. Flow chart illustrating number of trials evaluated at each stage in the systematic review of clavicle fractures. ^a Studies are assessed to originate from the same patient population. Results are reported from the recent (2011) study, thus the final number of studies was 13.

Table 1. Characteristics of the included studies (n=13) in systematic review of clavicle fractures

A	B	C	D	E	F	G	H	I	J
Hoofwijk 1988Netherlands	RCT	M	NM	< / >1 clavicle width	Rucksack bandage (78)	Mitella (79)	10 months	157/152	3.2
COTS 2007Canada	RCT	M	NM	Completely displaced, no cortical contact between main fragments	Plate (67)	Sling (65)	1 year	132/111	15.9
Shen 2008China	RCT	M	NM	Compeletely displaced	3D reconstruction plate (67)	Superior reconstruction plate (66)	1 year	133/117	12.0
Judd 2009United States	RCT	M	NM	Displaced or angulated	Hagie pin (29)	Sling (28)	1 year	57/50	12.3
Smekal 2009, 2011 Austria ^b	RCT	M	OTA	Displaced, no cortical contact between main fragments	ESIN (60)	Sling (60)	2 years	120/112	6.7
Ferran 2010UK	RCT	M	NM	Displaced and shortened with complete overlap of bone ends	Rockwood pin (17)	Plate (15)	1 year	32/32	0
Jubel 2005Germany	CCT	M	Allman OTA	Allman IOTA A or B	ESIN (26)	Rucksack bandage (27)	6 months	53/53	0
Lee 2007Taiwan	CCT	M	NM	Not mentioned	Knowles pin (32) ^a	Dynamic compression plate (30) ^a	30 months	69/62	10.1
Lee 2008Taiwan	CCT	M	NM	Not mentioned	Knowles pin (56) ^a	Plate (32) ^a	1 year	103/88	14.6
Pai 2009Taiwan	CCT	M	NM	Not mentioned	Locking compression plate (29) ^a	Nonlocking plate (35) ^a	1 year	76/64	15.8
Hsu 2010Taiwan	CCT	L	Neer	Neer II	Hook plate (35)	Tension band wire (30)	6 months	65/65	0
Böhme 2011Germany	CCT	M	AO	AO 15-B: types A1, A2, B1, B2, C1, C2	Plate (53)ESIN (20)	Rucksack bandage (47)	8 months	120/96	20
Kulshrestha 2011, India	CCT	M	OTARobinson	OTA 15-BRobinson 2B1 and 2B2	Plate (45)	Sling (28)	18 months	73/68	6.8

A Author, year, country

 COTS = Canadian Orthopaedic Trauma Society

B Study design

 RCT randomized controlled trial

 CCT controlled clinical trial

C Location of the fracture

 M middle

 L lateral

D Classification of the fracture

 NM not mentioned

E Displacement of the fracture

 OTA Orthopaedic Trauma Association

F Intervention (no. of patients)

 ESIN elastic stable intramedullary nail

G Control (no. of patients)

H Follow-up time

I No. of patients at initiation / at follow-up

J Percentage of drop-out

^a Studies report no. of patients only at follow-up.

^b Studies are assessed to originate from the same patient population. Results are reported from the recent (2011) study.

Table 2. Criteria for risk of bias assessment for the trials included (n=13) in the systematic review (Furlan et al. 2009). If ≥ 6 criteria were met, the trial is assessed to have low risk of bias

Author, year, country	1.	2.	3.	4.	5.	6.	7.	8.	9.	10.	11.	12.	Total
Randomized controlled trials
Hoofwijk 1988 Netherlands	Yes	Unclear	NA	NA	NA	No	Yes	Yes	Yes	Yes	Yes	Unclear	6
COTS 2007 Canada	Yes	Yes	NA	NA	NA	No	Yes	Yes	Yes	Yes	Yes	Yes	8
Shen 2008 China	Yes	Yes	Unclear	Unclear	Yes	No	Unclear	Yes	Yes	Yes	Yes	Yes	8
Judd 2009 United States	Yes	Yes	NA	NA	NA	No	Unclear	Yes	Yes	Yes	Yes	Yes	7
Smekal 2009, 2011 Austria ^a	No	Unclear	NA	NA	NA	No	No	Yes	Yes	Yes	Yes	Yes	5
Ferran 2010 United Kingdom	Yes	Yes	NA	NA	NA	Unclear	Yes	Yes	Yes	Yes	Yes	Unclear	7
Controlled clinical trials
Jubel 2005 Germany	No	No	NA	NA	NA	Yes	Unclear	Yes	Yes	Yes	Yes	Yes	6
Lee 2007 Taiwan	No	No	NA	NA	NA	Yes	Yes	Yes	Yes	Yes	Yes	Unclear	6
Lee 2008 Taiwan	No	No	NA	NA	NA	Yes	Yes	Yes	Yes	Yes	Yes	Yes	7
Pai 2009 Taiwan	No	No	No	NA	NA	Yes	Unclear	Yes	Yes	Yes	Yes	Yes	6
Hsu 2010 Taiwan	No	No	NA	NA	NA	Yes	Yes	Yes	Yes	Yes	Yes	Yes	7
Böhme 2011 Germany	No	No	NA	NA	NA	No	Unclear	Yes	No	Yes	Yes	No	3
Kulshrestha 2011 India	No	No	No	NA	NA	Yes	Yes	Yes	Yes	Yes	Yes	Yes	7

1. Was the method of randomisation adequate?

2. Was the treatment allocation concealed?

3. Was the patient blinded to the intervention?

4. Was the care provider blinded to the intervention?

5. Was the outcome assessor blinded to the intervention?

6. Was the drop-out rate described and acceptable?

7. Were all randomized (CCT: allocated) participants analysed in the group they were allocated?

8. Are reports of the study free of suggestion of selective outcome reporting?

9. Were the groups similar at baseline regarding the most important prognostic indicators?

10. Were co-interventions avoided or similar?

11. Was the compliance acceptable in all groups?

12. Was the timing of the outcome assessment similar in all groups?

^a Studies are assessed to originate from the same patient population. Results are reported from the recent (2011) study.

Abbreviations:

NA = Not applicable

COTS = Canadian Orthopaedic Trauma Society

Table 4. Reported complications in the studies (n=13) approved to the systematic review of clavicle fractures

Author, year, country	Methods^a	Non-union	Mal-union	Delayed union	Wound infection	Hardwareorbandage irritation	Mechanical failure of osteosynthesis	Protrusion or dislocation of implant	CRPS^a	Brachial plexus symptoms	Other	All complications (%)
Hoofwijk 1988 Netherlands	RSBM	4/740/78		1/740/78						0/741/78		5/74 (7)1/78 (1)
COTS^a 2007 Canada	PlateSling	2/627/49	0/629/49		3/62	5/62	1/62		0/621/49	8/627/49	4/627/49	23/62 (37)31/49 (63)
Shen 2008 China	3DPSP			1/678/66								1/67 (1)8/66 (12)
Judd 2009 United States	H pinSling	1/291/28		1/29	6/29 superf.2/29 deep	9/29	1/29				2/291/28	22/29 (76)2/28 (7)
Smekal 2009, 2011, Austria ^b	ESINSling	0/606/52	0/602/52	2/609/52	1/60	5/60	9/60			0/603/52	1/600/52	18/60 (30)20/52 (39)
Ferran 2010 UK	RPPlate	0/170/15			0/173/15	1/170/15	1/170/15				2/171/15	4/17 (24)4/15 (27)
Jubel 2005 Germany	ESINRSB	0/262/27			0/260/27	7/269/27		4/260/27		1/264/27	2/266/27	14/26 (54)21/27 (78)
Lee 2007 Taiwan	KPPlate	0/321/30			0/321/30	4/3212/30	0/322/30					4/32 (13)16/30 (53)
Lee 2008 Taiwan	KPPlate	0/561/32			0/561/32	4/5612/32	0/561/32					4/56 (7)15/32 (47)
Pai 2009 Taiwan	LCPNLP	1/291/35			0/291/35	11/2914/35	0/294/35					12/29 (41)20/35 (57)
Hsu 2010 Taiwan	HPTB	0/350/30					9/350/30	0/355/30				9/35 (26)5/30 (12)
Böhme 2011 Germany	RSBPlateESIN	1/470/530/20	1/470/530/20	1/470/530/20	2/530/20		0/474/531/20			0/470/531/20	4/471/531/20	7/47 (15)7/53 (13)3/20 (15)
Kulshrestha 2011, India	PlateSling	0/458/28	2/4510/28	2/450/28		4/45	2/45				2/458/28	12/45 (27)26/28 (93)

^a Abbreviations:

CRPS= Complex regional pain syndrome

RSB=Rucksack bandage

M = Mitella

COTS = Canadian Orthopaedic Trauma Society

3DP = Three-dimensional plate

SP = Superior plate

H pin = Hagie pin

ESIN = Elastic stable intramedullary nail

RP = Rockwood pin

KP = Knowles pin

LCP = Locking compression plate

NLP = Non-locking plate

HP = Hook plate

TB = Tension band

^b Studies are assessed to originate from the same patient population. Results are reported from the recent (2011) study.

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