Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures: A systematic review

Table 1 Included randomized controlled trials with characteristics

First author (last name)	Journal	Year	Comparison	Patients enrolled	Patients lost to follow up	Final study, n	JADAD score	Power analysis
Kim	J Orthop Trauma	2015	ORPO (LCP) vs MIPO	72	4	68	3	Yes
Esmailiejah	Trauma Mon	2015	ORPO (DCP) vs MIPO	68	3	65	3	No
Fan	Orthopedics	2015	ORPO (LCP) vs IMN	60	0	60	2	Yes
Hadhoud	Menoufia Medical Journal	2015	ORPO (LCP) vs MIPO	30	0	30	2	No
Wali	Strategies Trauma Limb Reconstr	2014	ORPO (DCP) vs IMN	50	0	50	2	No
Benegas	J Shoulder Elbow Surg	2014	MIPO vs IMN	41	1	40	3	Yes
Lian	Orthopedics	2013	MIPO vs IMN	56	9	47	3	No
Li	J Shoulder Elbow Surg	2011	ORPO (LCP) vs IMN	50	5	45	3	Yes
Iqbal	Annals of King Edward Medical University	2011	ORPO (DCP) vs IMN	40	0	40	3	No
Singisetti	Int Orthop	2010	ORPO (DCP) vs IMN	45	9	36	1	No
Putti	J Orthop Surg (Hong Kong)	2009	ORPO (DCP) vs IMN	34	0	34	2	No
Changulani	Int Orthop	2007	ORPO (DCP) vs IMN	47	2	45	3	No
Kesemenli	Acta Orthop Traumatol Turc	2003	ORPO (DCP) vs IMN	60	0	60	2	No
McCormack	J Bone Joint Surg (Br)	2000	ORPO (DCP) vs IMN	44	3	41	2	No
Chapman	J Orthop Trauma	2000	ORPO (DCP) vs IMN	89	5	84	3	No

ORPO: Open reduction and plate osteosynthesis; DCP: Dynamic compression plate; LCP: Locking compression plate; IMN: Intramedullary nail; MIPO: Minimally invasive plate osteosynthesis.

Table 2 Summary characteristics of included randomized controlled trials

Characteristic	No.	% or range
Initial sample size, mean No.	52.4	(30-89)
Lost to follow up, mean No.	2.7	(0-9)
Final sample size, mean No.	49.7	(30-84)
Power analysis	4	26.7%
Comparison groups
ORPO (DCP) vs IMN	8	53.3%
ORPO (LCP) vs IMN	2	13.3%
MIPO vs IMN	2	13.3%
ORPO (LCP) vs MIPO	2	13.3%
ORPO (DCP) vs MIPO	1	6.7%
Outcome assessed
Delayed union/nonunion	15	100.0%
Iatrogenic radial nerve palsy	15	100.0%
Infection	14	93.3%
Secondary surgeries	11	73.3%
Shoulder impingement	10	66.7%
Malunion	7	46.7%
Elbow stiffness	4	26.7%

ORPO: Open reduction and plate osteosynthesis; DCP: Dynamic compression plate; LCP: Locking compression plate; IMN: Intramedullary nail; MIPO: Minimally invasive plate osteosynthesis.

Table 3 Fragility index values for each outcome for included randomized controlled trials

First author (last name)	Comparison	Delayed union/ Nonunion	Iatrogenic radial nerve palsy	Infection	Malunion	Shoulder Impingement	Elbow Stiffness	All complications	Secondary surgeries
Kim	ORPO (LCP) vs MIPO	0	0	0	0	NA	NA	0	0
Esmailiejah	ORPO (DCP) vs MIPO	0	0	0	0	NA	NA	0	0
Fan	ORPO (LCP) vs IMN	0	0	NA	NA	NA	NA	0	NA
Hadhoud	ORPO (LCP) vs MIPO	0	0	0	NA	NA	NA	0	NA
Wali	ORPO (DCP) vs IMN	0	0	0	NA	0	0	0	0
Benegas	MIPO vs IMN	0	0	0	0	0	NA	0	0
Lian	MIPO vs IMN	0	0	0	0	1	0	4	NA
Li	ORPO (LCP) vs IMN	0	0	0	2	NA	NA	0	NA
Iqbal	ORPO (DCP) vs IMN	0	0	0	NA	0	NA	0	0
Singisetti	ORPO (DCP) vs IMN	0	0	0	NA	0	0	0	0
Putti	ORPO (DCP) vs IMN	0	0	0	NA	0	NA	0	0
Changulani	ORPO (DCP) vs IMN	0	0	0	NA	1	NA	0	0
Kesemenli	ORPO (DCP) vs IMN	0	1	0	NA	0	NA	0	0
McCormack	ORPO (DCP) vs IMN	0	0	0	0	2	NA	6	1
Chapman	ORPO (DCP) vs IMN	0	0	0	0	2	1	0	0

ORPO: Open reduction and plate osteosynthesis; DCP: Dynamic compression plate; LCP: Locking compression plate; IMN: Intramedullary nail; MIPO: Minimally invasive plate osteosynthesis.

Table 4 Summary of outcomes with reported differences between groups

Continuous variable	Superior treatment	Inferior treatment	First author (last name)
Time to union	IMN	ORPO	Changulani
Time to union	IMN	ORPO	Fan
Operative time	IMN	ORPO	Fan
Operative time	IMN	ORPO	Wali
Operative time	MIPO	IMN	Lian
Operative time	MIPO	ORPO	Hadhoud
Intraoperative blood loss	IMN	ORPO	Fan
Intraoperative blood loss	IMN	ORPO	Wali
Intraoperative blood loss	MIPO	IMN	Lian
Hospital stay	IMN	ORPO	Fan
Hospital stay	IMN	ORPO	Wali
Constant scores	MIPO	IMN	Li
Rodriguez-Merchan criteria	DCP	IMN	Singisetti
Shoulder ROM	MIPO	IMN	Li
Shoulder ROM	DCP	IMN	Chapman
Elbow ROM	IMN	DCP	Chapman

ORPO: Open reduction and plate osteosynthesis; DCP: Dynamic compression plate; LCP: Locking compression plate; IMN: Intramedullary nail; MIPO: Minimally invasive plate osteosynthesis.