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Surgical interventions for treating distal humeral fractures in adults

  1. Yan Wang1,
  2. Qi Zhuo1,*,
  3. Peifu Tang1,
  4. Wei Yang2

Editorial Group: Cochrane Bone, Joint and Muscle Trauma Group

Published Online: 31 JAN 2013

Assessed as up-to-date: 1 AUG 2012

DOI: 10.1002/14651858.CD009890.pub2


How to Cite

Wang Y, Zhuo Q, Tang P, Yang W. Surgical interventions for treating distal humeral fractures in adults. Cochrane Database of Systematic Reviews 2013, Issue 1. Art. No.: CD009890. DOI: 10.1002/14651858.CD009890.pub2.

Author Information

  1. 1

    Chinese PLA General Hospital, Department of Orthopaedic Surgery, Beijing, Beijing, China

  2. 2

    Chinese PLA General Hospital, Department of Endocrinology, Beijing, Beijing, China

*Qi Zhuo, Department of Orthopaedic Surgery, Chinese PLA General Hospital, 28 Fuxing Road, Beijing, Beijing, 100853, China. qizhuo301@gmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 31 JAN 2013

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Characteristics of included studies [ordered by study ID]
McKee 2009

MethodsDouble-blind RCT

Method of randomisation: a random number generator

Assessor blinded

Number lost to follow-up: 2

Length of follow-up: 24 months


Participants42 patients over the age of 65 years with displaced, comminuted, intraarticular fractures of the distal humerus (OTA/AO type 13C fracture)

4 university-affiliated Canadian medical centres

Date of study: not fully stated (only "beginning at year 2001" was mentioned)

5 male, 35 female; mean age 77 years in ORIF group, 78 years in TEA group

Exclusion criteria: extra-articular or partial articular fractures of the distal humerus, Gustilo grade I open fractures that had not had irrigation and debridement within 12 hours of occurrence, Gustilo grade II, IIIa, IIIb, and IIIc open fractures, associated vascular injury, previous ipsilateral distal humeral fracture, pathologic fractures, fractures with diaphyseal extension of 8 cm or greater, definitive surgery more than 21 days after injury, pre-existing severe joint disease, and limited life expectancy because of significant medical comorbidity.


InterventionsAll fractures were treated within 12 hours of injury. General anaesthesia used in all cases. Preoperative prophylactic antibiotics given to all cases. Six surgeons performed the procedures. The ulnar nerve was transposed in all cases. Both the two groups had the same rehabilitation protocol.

ORIF group: dual plates placed on medial and lateral columns in all cases, with 10 placed at 90°, and 5 placed parallel to each other. Different kinds of plates were used, including 15 precontoured plates, nine 3.5-mm pelvic reconstruction plates, and six limited-contact 3.5-mm compression plate. No 1/3 tubular or locking plates were used in the ORIF group. All ORIF was performed via a posterior approach with anatomic reduction of the fracture and provisional Kirschner wire fixation. [25]

TEA group: Semiconstrained (Coonrad - Morrey elbow prosthesis, Zimmer, Warsaw, IN) TEA was implanted with antibiotic-impregnated bone cement (40 grams of Simplex Bone Cement powder plus 1 gram of tobramycin; Stryker Canada, Hamilton, Ontario) in all cases. A midline triceps split or triceps-sparing approach was used for TEA. [15]


OutcomesPrimary outcome: reoperation rate.

Secondary outcome: MEPS and DASH scores.


NotesInitially 42 patients were randomised into two groups with each one comprising 21, but one died in each group and for 5 patients of the ORIF group a decision was made intra-operatively for conversion to TEA. Patients converted from ORIF to TEA were considered in the TEA group in the trial analyses.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "A random number generator was used to create a 1:1 allocation scheme"

Allocation concealment (selection bias)Low riskQuote: "A sealed envelope containing the randomly assigned treatment group allocation was opened by the study coordinator, not the surgeon."

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of the surgeon and the patients in this trial was not practical due to the physical nature of the interventions.

Blinding of outcome assessment (detection bias) (functional outcomes, pain, clinical outcomes, complications)Unclear riskQuote: "A research assistant, blinded to the treatment group, and the attending physician, who was not blinded, performed a standardized clinical assessment of all patients preoperatively and postoperatively." Insufficient information to judge whether the attending physician's awareness of the grouping status would influence the judgment of the research assistant, and thus bias the final conclusion.

Blinding of outcome assessment (detection bias) (reoperation, treatment failure, range of motion)Low riskLack of blinding unlikely to affect assessment of these outcomes.

Incomplete outcome data (attrition bias)
All outcomes
High riskParticipant flow provided, but two (4.8%) died of unrelated causes before complete follow-up and were excluded from the analysis of the data. In addition, there was a 5 out of 20 patients (25%) intraoperative conversion to TEA in the ORIF group because of "extensive comminution and an inability to achieve stable fixation". This means no ITT analysis was followed, despite the author's claim that no significant difference existed (data not presented).

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this.

Balance in baseline characteristicsLow riskQuote: "There were no significant differences between the groups in terms of age, gender, weight, baseline pre-injury DASH, injury severity score, mechanism of injury, smoking status, baseline activity, and fracture type."

Extra performance bias (care programmes and surgical experience, etc.)Unclear riskThere were 6 surgeons performing the operations, and their seniority or experience was not mentioned. Different types of plates and plating techniques were used in the ORIF group. All this increased the heterogeneity, but not necessarily the bias concerned. Conversely, a standardized protocol was followed in the trial. Therefore, McKee 2009 was labelled as unclear risk.

Ruan 2009

MethodsRCT

Method of randomisation not described

Assessor blinding not described

Number lost to follow-up: 0

Length of follow-up: 29.5 months on average, ranging from 25 to 38 months


Participants29, out of 117 consecutive patients with AO type C fractures of distal humerus, who exhibited preoperative ulnar nerve compression symptoms.

One university affiliated hospital in Shanghai, China

Date of study: from June 1998 to October 2005

9 male and 6 female, mean age 45.1 years in the group with anterior subfascial (meaning subcutaneous) transposition of the ulnar nerve.
10 male and 4 female, mean age 40.7 years in the in situ decompression (ISD) group.


InterventionsAll fractures were treated using ORIF within 2 weeks of injury. General anaesthesia was used in all cases. The number of surgeons performing the procedures was not reported. Both groups followed the similar post-operative rehabilitation protocol.

Transposition Group: the ulnar nerve underwent anterior subfascial  transposition along with its arteries.[15]

ISD group: the ulnar nerve underwent decompression in the original position.[14]


OutcomesUlnar nerve recovery and Bishop rating system (No details given)


NotesTwo 3.5-mm reconstruction plates (DePuy ACE, Johnson & Johnson Company, Switzerland) were used in all ORIF procedures, but neither details regarding the position of the dual plates, nor preoperative severity of ulnar nerve dysfunction were provided.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo details provided.

Allocation concealment (selection bias)Unclear riskNo details provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of the surgeon in this trial was not practical, due to the physical nature of the interventions. Blinding of the patients was not reported.

Blinding of outcome assessment (detection bias) (functional outcomes, pain, clinical outcomes, complications)High riskNo details provided, but this was taken to suggest that there was no blinding, and rated as "high risk" for functional outcomes.

Blinding of outcome assessment (detection bias) (reoperation, treatment failure, range of motion)Low riskN/A

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo losses to follow up.

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this.

Balance in baseline characteristicsUnclear riskThe age, time to operation, and fracture subtypes between the two groups was not significantly different. But the severity of ulnar nerve dysfunction was not differentiated between the two groups.

Extra performance bias (care programmes and surgical experience, etc.)Unclear riskThe number of surgeons performing the procedures were not mentioned, but the author suggested that the surgical techniques, plates used, and the postoperative rehabilitation protocols were the same for the two groups.

Shin 2010

MethodsRCT

Method of randomisation: a computer random number generator

Assessor not blinded

Number lost to follow-up: 3

Length of follow-up: 40.3 months on average, ranging from 24 to 93 months


Participants38 consecutive patients (3 lost to follow-up, but no details were reported) with closed intraarticular fractures of the distal humerus (OTA/AO type C fracture)

Study setting: Seoul, South Korea

Date of study: from March 2002 to November 2006

11 male, 23 female; mean age 52.5 years (range 18 to 94) in group using orthogonal plating, 56.1 years (range 18 to 83) in the group using parallel plating

Exclusion criteria: extraarticular distal humerus fractures, or with a previous operative treatment, or of a pathologic fracture around elbow.


InterventionsAll fractures were treated within five days of injury, except for one whose surgery was delayed due to internal organ injuries. Method of anaesthesia was not reported. A single surgeon performed the procedures. The ulnar nerve was transposed in all cases. Both groups followed the same post-operative rehabilitation and heterotopic ossification prevention protocol.

Group I: using 2 orthogonal/perpendicular plates, with 1 placed along the medial supracondylar ridge and another placed posterolaterally. A 3.5-mm reconstruction plate was used for the lateral column, while in the medial column, 2 different plates were used, including ten 3.5-mm reconstruction plates, seven pre-contoured anatomical plates (Acumed, Hillsboro, OR). [17]

Group II: dual plates, parallel with each other, placed along each supracondylar ridge. Pre-contoured anatomical plates were employed in all patients of the group. [18]


OutcomesIncidence of complications, including nonunion, metal failure, and heterotopic ossification.

Range of motion

Union time

MEPS


NotesPostoperative rehabilitation protocol: "passive and active assisted range of elbow motion exercises commenced at 3 days postoperatively."

Heterotopic ossification prevention: "patients underwent prophylactic radiotherapy 3 times after the operative day, and on each occasion received 200 Cgy. Indomethacin (oral dosage of 75 mg) was administered to all patients for 2 weeks postoperatively."


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Randomization was performed based on a computer random number generator determining the order of 1 of 2 fixation methods."

Allocation concealment (selection bias)Unclear riskNo details provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of the surgeon in this trial was not practical, due to the physical nature of the interventions. Blinding of the patients was not reported.

Blinding of outcome assessment (detection bias) (functional outcomes, pain, clinical outcomes, complications)High riskNo details provided, but this was taken to suggest that there was no blinding, and rated as "high risk" for functional outcomes.

Blinding of outcome assessment (detection bias) (reoperation, treatment failure, range of motion)Low riskNo details, but lack of blinding unlikely to affect assessment of these outcomes.

Incomplete outcome data (attrition bias)
All outcomes
High risk3 patients (7.9%) were lost to follow-up, but no details were provided. No intention-to-treat (ITT) analysis has been conducted.

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this.

Balance in baseline characteristicsLow riskThe age, male/female ratio, time to operation, fracture subtypes, and common cause of injuries between the 2 groups was not significantly different.

Extra performance bias (care programmes and surgical experience, etc.)Unclear riskPlates used in the ORIF procedures were not always the same between the 2 groups. Otherwise, a single surgeon performed all operations, and the postoperative rehabilitation (etc) were the same for both groups.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Aktekin 2008Participants were children.

Jain 2009Ongoing study focusing on type I supracondylar humerus fractures in children.

Mulpuri 2009Ongoing study focusing on supracondylar humerus fractures in children.

Mulpuri 2011Ongoing study focusing on type III supracondylar humerus fractures in children.

Prasad 2008Study testing secondary surgery after failed non-surgical or ORIF treatment.

Schmale 2009Ongoing study focusing on supracondylar humerus fractures in children.

 
Characteristics of studies awaiting assessment [ordered by study ID]
Frankle 1996

MethodsPatients were "randomised by the surgeon" for either total elbow arthroplasty or ORIF. "The patients were evaluated by a research nurse and not under the auspices of either surgeon."
Length of follow-up: "at least eighteen months postoperatively".

Participants10 elderly female with elbow fractures

Interventions1. Total elbow arthroplasty. [6]

2. ORIF. [4]

OutcomesPatients were evaluated postoperatively "according to the scale of Broberg and Morey".

NotesOf note, the authors described their study as "retrospective" in the study title. There were patients with elbow dislocation and coronoid fractures involved. All operations were performed by the same surgeon. So far, we have no access to the report of this study other than the abstract provided in the AAOS scientific program.

IIyas 2001

MethodsNo randomisation was mentioned in the abstract of the study. Study period: 1993 to 1997. 6 losses to follow-up.

Participants50 patients with intra-articular fractures of distal humerus.

Study setting: Teaching hospital in Quetta.

InterventionsAll patients underwent ORIF, with one of the two following surgical approaches:

1. Triceps Tongue approach

2. Trans-olecranon approach

No information was given regarding the number of participants in each group.

OutcomesNo details were given regarding outcome measures.

NotesWe were only able to find the abstract of the study. No single methodological item was mentioned, and thus it was regarded as highly biased.

Kruger 1985

Methods"In a randomised series", 33 patients out of 45 were followed up ranging from 6 weeks to 2 years.

Participants45 patients with distal humeral fractures

Interventions1. Overhead skeletal traction

2. Closed reduction

3. "Bag of bone" methods

4. ORIF

No information was given regarding the number of participants in each of the four groups.

OutcomesElbow range of motion

Grip strength

Pain

NotesWe were only able to find the abstract of the study, which was conducted 27 years ago.

 
Comparison 1. Open reduction - internal fixation (ORIF) versus total elbow arthroplasty (TEA)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Mayo elbow performance score (MEPS): 0 to 100 (best outcome)Other dataNo numeric data

    1.2 6 months (on treatment data)
Other dataNo numeric data

    1.3 12 months (on treatment data)
Other dataNo numeric data

    1.4 2 years (on treatment data)
Other dataNo numeric data

 2 Excellent or good MEPS at 2 years1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 3 Disability of the Arm, Shoulder, Hand score (DASH): 0 to 100 (worst outcome)Other dataNo numeric data

    3.2 6 months (on treatment data)
Other dataNo numeric data

    3.3 12 months (on treatment data)
Other dataNo numeric data

    3.4 2 years (on treatment data)
Other dataNo numeric data

 4 Reoperation rate (treatment received analysis))1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 5 Treatment failure (conversion and reoperation) (intention-to-treat analysis)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 6 Adverse events1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    6.1 One or more complications
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.2 Ulnar nerve dysfunction
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.3 Nonunion
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.4 Post-traumatic stiffness
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.5 Heterotopic ossification (type III)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.6 Infection
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.7 Would complication
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.8 Radial nerve palsy (temporary)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.9 Malalignment > 5°
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.10 Incongruent reduction >2mm
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 7 Range of motion at 2 years (degrees)Other dataNo numeric data

    7.1 Extension (on treatment data)
Other dataNo numeric data

    7.2 Flexion (on treatment data)
Other dataNo numeric data

    7.3 Arc of motion of flexion-extension (on treatment data)
Other dataNo numeric data

    7.4 Arc of motion of pronation-supination (on treatment data)
Other dataNo numeric data

 8 Duration of operation (minutes)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 9 Length of hospital stay (days)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 
Analysis 1.1 Comparison 1 Open reduction - internal fixation (ORIF) versus total elbow arthroplasty (TEA), Outcome 1 Mayo elbow performance score (MEPS): 0 to 100 (best outcome).
Mayo elbow performance score (MEPS): 0 to 100 (best outcome)

StudyOutcome measureORIF (n = 15)TEA (n = 25)Reported significance

6 months (on treatment data)

McKee 2009MEPSmean = 68mean = 86P = 0.003

12 months (on treatment data)

McKee 2009MEPSmean = 72mean = 88P = 0.007

2 years (on treatment data)

McKee 2009MEPSmean = 73mean = 86P=0.015

 
Analysis 1.3 Comparison 1 Open reduction - internal fixation (ORIF) versus total elbow arthroplasty (TEA), Outcome 3 Disability of the Arm, Shoulder, Hand score (DASH): 0 to 100 (worst outcome).
Disability of the Arm, Shoulder, Hand score (DASH): 0 to 100 (worst outcome)

StudyOutcome measureORIF (n = 15)TEA (n = 25)Reported significance

6 months (on treatment data)

McKee 2009DASHmean = 47mean = 31P = 0.04

12 months (on treatment data)

McKee 2009DASHmean = 47mean = 31P = 0.07

2 years (on treatment data)

McKee 2009DASHmean = 43mean = 32P = 0.18

 
Analysis 1.7 Comparison 1 Open reduction - internal fixation (ORIF) versus total elbow arthroplasty (TEA), Outcome 7 Range of motion at 2 years (degrees).
Range of motion at 2 years (degrees)

StudyOutcome measureORIF
(n = 15)
TEA
(n = 25)
Reported significance

Extension (on treatment data)

McKee 2009Extensionmean = 28°

range = 5° to 60°
mean = 26°

range = 0° to 72°
Statistical significance was not reported. Quote: " Although there was a trend toward improved motion in the TEA group (by 12°), the mean extension, flexion, and arc of motion of flexion-extension were not significantly different between the ORIF group and TEA group at 2 years."

Flexion (on treatment data)

McKee 2009Flexionmean = 123°

range = 90° to 150°
mean = 133°

range = 90° to 155°
Statistical significance was not reported. Quote: " Although there was a trend toward improved motion in the TEA group (by 12°), the mean extension, flexion, and arc of motion of flexion-extension were not significantly different between the ORIF group and TEA group at 2 years."

Arc of motion of flexion-extension (on treatment data)

McKee 2009Arc of motion of flexion-extensionmean = 95°

range = 30° to 140°
mean = 107°

range = 42° to 145°
Statistical significance was not reported. Quote: "Although there was a trend toward improved motion in the TEA group (by 12°), the mean extension, flexion, and arc of motion of flexion-extension were not significantly different between the ORIF group and TEA group at 2 years."

Arc of motion of pronation-supination (on treatment data)

McKee 2009Arc of motion of pronation-supinationmean = 160°

range = 90° to 180°
mean = 172°

range = 110° to 180°
P = 0.13

 
Comparison 2. Perpendicular versus parallel double plate fixation

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Mayo elbow performance score (MEPS) at 2+ years: 0 to 100 (best outcome)Other dataNo numeric data

 2 Excellent or good results from MEPS1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 3 Re-operation1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 Re-operation for complication
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.2 Requested hardware removal
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Adverse events1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 Patients with complications
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.2 Nonunion
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.3 Arthrofibrosis
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.4 Heterotopic ossification
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.5 Ulnar never dysfunction persisting after 3 months postoperatively
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Range of motion (degrees)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    5.1 Arc of flexion
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.2 Flexion
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.3 Extension
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 6 Bony union time (months)Other dataNo numeric data

 
Analysis 2.1 Comparison 2 Perpendicular versus parallel double plate fixation, Outcome 1 Mayo elbow performance score (MEPS) at 2+ years: 0 to 100 (best outcome).
Mayo elbow performance score (MEPS) at 2+ years: 0 to 100 (best outcome)

StudyOutcome measurePerpendicular group (n=17)Parallel group (n=18)Reported significance

Shin 2010MEPSmean = 91.5

range = 70 to 100
mean = 94.3

range = 70 to 100
P = 0.928

 
Analysis 2.6 Comparison 2 Perpendicular versus parallel double plate fixation, Outcome 6 Bony union time (months).
Bony union time (months)

StudyOutcome measurePerpendicular group (n = 17)Parallel group (n = 18)Reported significance

Shin 2010Bony union timemean = 6.3mean = 5.4P = 0.436

 
Comparison 3. Ulnar nerve transposition group versus in situ decompression (ISD) group

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Complete recovery of ulnar nerve function1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 2 Bishop rating system of ulnar nerve function grades1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Good or excellent results
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 Excellent results
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Table 1. Items relating to applicability of evidence

Clearly defined study population?Clearly defined intervention?Well-accepted and comprehensive outcome system?Adequate timing of follow-up?

McKee 2009YesYesYesPartial: the length of follow-up in ORIF is adequate (2 years); but 2 years is a relatively short time for joint arthroplasty assessment.

Shin 2010YesYesPartial: due to the lack of the more detailed validated patient-based functional outcome such as DASH scoring system.Partial: although an average time of follow-up being 40.3 months, the author did not clarify when each outcomes measure in the study were assessed.

Ruan 2009Partial: no clearly defined exclusion criteria reportedYesPartial: we considered Bishop rating system as a partially validated scoring system.Yes (29.5 months on average, ranging from 25 to 38 months)