Summary of findings 3. Locking plate versus locking intramedullary nail for surgical fixation of proximal humeral fractures.

Locking plate versus locking intramedullary nail for surgical fixation of proximal humeral fractures
Patient or population: adults undergoing surgery for displaced proximal humeral fracturesa (4 trials) Settings: hospital (tertiary care) Intervention: open reduction and internal fixation (ORIF) with locking plate Comparison: open reduction and internal fixation (ORIF) with locking intramedullary nail
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Locking nail	Locking plate
Self‐reported shoulder function: functional scoresb(higher = better outcome) Follow‐up: 1 year		The mean difference in function (overall) in the plate groups was 0.15 standard deviations higher (0.12 lower to 0.41 higher)	SMD 0.15(‐0.12 to 0.41)	227 participants (4 studies)	⊕⊕⊝⊝ Lowc	This is unlikely to represent a clinically important difference: statistically, 0.2 represents a small difference, 0.5 a moderate difference and 0.8 a large difference. Thus, based on this 'rule of thumb', the best estimate equates to a minimal difference between the two groups. However, the best estimates of between‐group differences for the pooled individual outcome scoresb were both smaller than their associated MCIDs.
Self‐reported shoulder function: DASH (0 to 100: higher = worse disability)b Follow‐up: 6 months	The mean DASH score in the nail groups ranged from 18.4 to 44.97	The mean DASH score was 0.39 lower in the plate groups (4.14 lower to 3.36 higher)	‐	174 (3 studies)	⊕⊕⊝⊝ Lowd	The MCID of 13.0 is greater than the 95% CI at this time period.
Self‐reported shoulder function: ASES (0 to 100: best outcome)b Follow‐up: 2 or 3 years	The mean ASES score in the nail groups ranged from 73.5 to 90	The mean ASES score was 3.06 higher in the plate group (0.05 lower to 6.17 higher)	‐	101 participants (2 studies)	⊕⊕⊝⊝ Lowe	The MCID of 12.01 is greater than the 95% CI at this time period.
Quality of life: SF‐36 (0 to 100: best outcome) Follow‐up: 1 year	The mean SF‐36 score in the nail group was 71.7	The mean SF‐36 score was 2.6 higher in the plate group (2.38 lower to 7.59 higher)	‐	53 participants (1 study)	⊕⊝⊝⊝ Very lowf	We have not identified an MCID for the SF‐36. It may be comparable to that for the SF‐12 at 6.5.
Mortality Follow‐up: 1 to 3 years	See comment		‐	176 participants (3 studies)	⊕⊝⊝⊝ Very lowg	There was no report of any fracture or surgery‐related death. Four of the 11 reported deaths were reported explicitly as having been from unrelated causes.
Adverse events: number of participants with complications Follow‐up: 1 to 3 years	217 per 1000h	241 per 1000 (152 to 380)	RR 1.11 (0.70 to 1.75)	250 participants (4 studies)	⊕⊝⊝⊝ Very lowi	By illustration, using a plate resulted in 24/1000 fewer participants having a complication up to 3 years (95% CI 65 fewer to 163 more). All 3 trials reported on individual complications: screw penetration into the humeral head, reported by all 4 trials, was the most common (occurring in 35% of those with complications).
Additional surgery (reoperation or secondary surgery) Follow‐up: 1 year	139 per 1000h	102 per 1000 (46 to 224)	RR 0.73 (0.33 to 1.61)	193 participants (3 studies)	⊕⊝⊝⊝ Very lowj	By illustration, using a plate resulted in 37/1000 fewer participants having additional surgery up to 1 year (95% CI 93 fewer to 85 more). However, these results are based on a total of 22 events in all.
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ASES: American Shoulder and Elbow Surgeons; CI: confidence interval; DASH: Disability of the Arm, Shoulder and Hand questionnaire; MCID: minimal clinically important difference; RR: risk ratio; SF‐36: 36‐item Short‐Form Health Survey; SMD: standardised mean difference
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect.

^aThe inclusion/exclusion criteria varied among the trials: one (72 participants) included 2‐ or 3‐part surgical neck fractures; one (81 participants) included 2‐, 3‐ and 4‐part fractures; and two (117 participants) included 2‐part surgical neck fractures only. Of the 250 recorded fractures, 63% were 2‐part and 33% were 3‐part.
^bThe two patient‐reported functional scores used in this analysis were the Disability of the Arm, Shoulder and Hand questionnaire (DASH; 2 trials), and the American Shoulder and Elbow Surgeons score (ASES; 2 trials).
^cThe evidence was downgraded by one level for serious study limitations, primarily reflecting a high risk of performance and detection bias relating to lack of blinding, and one level for serious inconsistency (heterogeneity: Chi² = 6.89, df = 3 (P = 0.08); I² = 56%).
^dThe evidence was downgraded one level for serious study limitations, reflecting a high risk of performance and detection bias relating to lack of blinding and selective reporting bias, and one level for serious inconsistency (heterogeneity: Chi² = 4.42, df = 2 (P = 0.11); I² = 55%).
^eThe evidence was downgraded one level for serious study limitations, primarily reflecting a high risk of performance and detection bias relating to lack of blinding, and one level for serious imprecision as the evidence was from just two small studies.
^fThe evidence was downgraded one level for serious study limitations, primarily reflecting a high risk of performance and detection bias relating to lack of blinding, and two levels for very serious imprecision as the evidence was from just one small study.
^gWith just 11 events, none of which appeared or were confirmed as being related to the fracture and treatment, the available data for this outcome are too limited to draw any conclusions or useful analysis. Nominally, we downgraded the evidence by one level for serious study limitations and two levels for very serious imprecision (very few events).
^hAssumed risk is the median control group risk across studies.
ⁱThe evidence was downgraded one level for serious risk of bias, one level for serious imprecision given the wide confidence interval, and one level for serious inconsistency (I² = 54%).
^jThe evidence was downgraded one level for serious risk of bias, one level for serious imprecision given the few events, and one level for serious inconsistency (I² = 53%).