Long term outcomes of open reduction internal fixation ...

[page 102] [Orthopedic Reviews 2019; 11:7809]

Long term outcomes of openreduction internal fixation versus external fixation of distal radius fractures: A meta-analysisConor Gouk,1,2 Shu-Kay Ng,3Matthew Knight,1 Randy Bindra,1,2Michael Thomas11Gold Coast University Hospital,Queensland; 2Griffith University, GoldCoast Campus, Queensland; 3GriffithUniversity, Menzies Health Institute,Nathan Campus, Queensland, Australia

AbstractDistal radius fractures are among the

most common fractures encountered in theclinical setting. Of these common fractures,it has been said that up to 60% are intra-articular in nature. Intra-articular or unsta-ble and comminuted fractures representsevere and high energy injuries. Despite alarge amount of literature, it is surgeon pref-erence which determines the fixationmethod employed. There are only a fewrandomised control trials that report 2-yearoutcomes. There has yet to be a meta-anal-ysis comparing the long-term outcomes ofopen reduction internal fixation (ORIF) andexternal fixation (EF). The aim of this meta-analysis is to identify any difference in theoutcomes of either fixation method in thelong term. We pooled the data of all theavailable randomised control trials that fol-lowed the patients for a minimum of 2 yearsand compared outcomes of ORIF againstEF of distal radius fractures as per PRISMAguidelines from inception of the databasesto December 2016. We then performed ourmeta-analysis using RevMan 5.3 software.Flexion/extension arcs were significantlyimproved in ORIF, and 7 of the 10 analysedoutcomes supported ORIF, although mostnot to a significant degree. The meta-analy-sis indicated that there is no difference inoutcomes with either form of treatment.Even though the flexion extension arc wasstatistically better in the ORIF group, thedifference is not clinically meaningful.

IntroductionDistal radius fractures are the most

common fracture encountered in the upperlimb,1,2 and are among the most commonfractures encountered in the clinical set-

ting.3,4 Up to 60% are intra-articular innature.5-7 Intra-articular, unstable and com-minuted fractures represent severe, oftenhigh energy injuries. Surgical interventionis indicated for unstable or irreducible frac-tures to restore the anatomical position ofthe wrist and the articular surface. This inturn decreases the likelihood of post-trau-matic osteoarthritis, increases functionalability, increases range of motion (ROM)and increases strength in the hand and wrist.Malunion has been associated with poorfunctional outcomes.8,9 Poor articular reduc-tion; persistent step >2 mm, has been asso-ciated with osteoarthritis8. Knirk and Jupiterreported significantly better overall resultsand significantly less radiographicosteoarthritis with restoration of articularcongruity.10 Kreder et al. found that with anarticular gap >2 mm, there was a 10.4 timeshigher risk of developing osteoarthritis.11

EF relies on the principles of ligamento-taxis to hold the reduction position; it hasthe benefits of being quick and minimallyinvasive, however it also has complications;pin sites predispose to local infection, theframe can be cumbersome and needs to beremoved.12 ORIF provides immediate fixa-tion of the fracture most often with plateosteosynthesis.13 ORIF has become the pre-dominate fixation method,14,15 particularlythe use of the volar locking plate (VLP).Plates may need to be removed under a sec-ond anaesthetic or regional block at a laterdate if symptomatic.6,16,17

The most recent Cochrane Review byHandoll and Madhok,18 was unable to deter-mine which fixation method was superior;Closed Reduction and External Fixation(EF) or Open Reduction and InternalFixation (ORIF).

Based on four RCT studies; Grewal,6Kreder,11 Kapoor,19 Leung,20 the AOFoundation advise that there is no consis-tent benefit of one treatment over another.21

It has been shown that the subjects thathave undergone ORIF improve rapidly postoperatively in both grip strength and ROMwhen directly compared with EF, howeverthis difference plateaus and the objectivefunctional outcomes become similar by oneyear.11,22-25 This has been attributed to pro-longed immobilisation in the case of EF,and conversely early mobilisation and phys-iotherapy in the case of ORIF. In the studyRozental et al., the authors could only rec-ommend ORIF for those patients who wishto receive “a faster return to function afterthe injury”.22 However, despite this trendingbelief, certain studies have shown that thisrapid recovery deficit is independent ofimmobilisation. Lozano-Calderon et al.found that early mobilisation in ORIF didnot have any effect on the outcome in ROM

or functional score.26 Other studies haveinadvertently found this, as although theyimmobilised their ORIF groups when com-paring them with external fixation, they stillfound a significant difference in the earlyperiods in favour of ORIF.23,27,28 Givenimmobilisation does not seem to cause thedisparity between ORIF and EF, there mustbe other influencing factors. Wright et al.reports that ROM progresses in its recoveryup to four years;29 a direct disagreementwith Kreder et al.’s belief that the outcomesat one year are final.11 We have analysed thelong-term outcomes of ORIF and EF inter-ventions.

Materials and MethodsA comprehensive literature search was

carried out, following the PRISMA 27 pointchecklist,30 and taking into considerationthe guidance offered by the CochraneCollaboration.31 We completed a systematicreview of PubMed, Embase, Medline andthe Cochrane Library, from inception toDecember 2016. Search terms “distalradius” and “fixation” returned 2687 arti-cles. This is an example of a search strategyused for PubMed: (distal[All Fields] AND(“radius”[MeSH Terms] OR “radius”[AllFields])) AND fixation[All Fields].

After the screening of the title andabstract by two of the authors (CG and MT)122 articles were deemed to be of rele-vance. On review we identified four com-parison studies and four randomised control

Orthopedic Reviews 2019; volume 11:7809

Correspondence: Conor Gouk, Gold CoastUniversity Hospital, 1 Hospital Blvd,Southport, Gold Coast, 4215 Queensland,Australia.Tel.: +61.1300744284.E-mail: [email protected]

Key words: Distal radius, fixation, trauma.

Contributions: the authors contributed equally.

Conflict of interest: the authors declare nopotential conflict of interest.

Received for publication: 4 August 2018.Accepted for publication: 2 May 2019.

This work is licensed under a CreativeCommons Attribution NonCommercial 4.0License (CC BY-NC 4.0).

©Copyright: the Author(s), 2019Licensee PAGEPress, ItalyOrthopedic Reviews 2019;11:7809doi:10.4081/or.2019.7809

or_2019_11_3.qxp_Hrev_master 23/09/19 13:26 Pagina 102

trials. The eligible randomised control trialswere Kapoor et al.,19 Xu et al.,32 Landgrenet al.33 and Williksen et al.34 A summarisedversion of this process is presented inSupplementary Figure S1.

Inclusion and exclusion criteriaInclusion and exclusion criteria are list-

ed in Table 1.

Data extractionData extraction was done in a systemat-

ic and methodical manor as outlined.Demographic data is summarised in Table2. The outcomes analysed were gripstrength, radiographic measurements (pal-mar tilt, radial inclination, ulnar variance),ROM, subjective functional scoring andcomplications/re-operations.

Data analysisWe used Review Manager Software

Version 5.3. The continuous data (gripstrength, radiographic parameters andROM) was expressed as mean differenceand 95% confidence intervals using theinverse variance method, with randomeffects model. Confidence intervals wereset to 95%. With Student’s t-test for statisti-cal significance and P<0.05 being evaluated

as statistically significant. I-squared testswere used to assess heterogeneity; an I-squared value <25% considered homoge-nous, an I-squared value between 25 and50% considered as low heterogeneity, an I-squared value between 50 and 75% consid-ered as moderate heterogeneity and an I-squared value >75% considered as high het-erogeneity.

Xu32 and Williksen34 presented theirdata as the range of individual movementsfrom the presumed neutral point as per tra-ditional anatomical position. Standard devi-ation, standard error or confidence intervalswere not provided, except the P-values ofthe differences between treatments. On theother hand, Landgren et al.33 presented theirdata as a full arc of movement, with stan-dard deviation and p values given. To com-pare the values, we combined the individualROM measures to create arcs of motion forthe studies by Xu and Williksen.32,34 Indoing so we combined the given p valueswith the assumptions of independence andsame direction of effects between the indi-vidual ROM measures using the online sta-tistical programme MetaP,35 which utilisedStouffer’s z trend test technique to combineprobabilities from independent tests with

adjustments for sample sizes and effectdirections.36

The dichotomous data (complications/re-operations) was expressed as risk ratio.This was calculated by the Mantel Hanselmethod, using random effect model and95% confidence intervals. Student’s t-testwas also used and again statistical signifi-cance taken to be P<0.05. Chi-square and I-squared tests were again used to assess het-erogeneity, with the same scale of what wasthought to be homogenous and heteroge-nous as outlined previously.

A total of 228 subjects were included inthe four trials. Of these 84 were male and144 female. Ages were comparable betweenthe four studies; however, Kapoor provideda mean age of 39 years which included theircasting treatment arm, and did not breakdown the ages any further. Total number ofsubjects that underwent ORIF was 117, andthe total number of subjects that underwentexternal fixation was 111. All external fixa-tors were bridging, and various methods ofORIF were employed. The fracture patternsand classification systems employed werevariable. Mean follow up was over twoyears as per the inclusion criteria. Theseresults are shown in Table 3.

Article

Table 1. Inclusion and exclusion criteria.

Inclusion Exclusion

Randomised control trials Open fracturesMethods of fixation that directly compared EF and ORIF Previous failed operative therapy to the affected sideEnglish translation manuscripts Non-compliant patientsAdult patients Paediatric patientsFollow up period ≥ 2yrs Pathological fractures Any augmentation of the ORIF group with external fixation Previous ipsilateral fracture of the wrist and/or forearm Patients suffering with memory disturbance; head injury or dementia

Table 2. Characteristics of the subjects.

Study No. Age Gender Centre No. ORIF Ex-Fix # Pattern No, Follow up Method (n) Method (n) Surgeons

Williksen et al. 91 54 (20-84) 13M 78F Single Acumed AcuLok (28) Hoffman II (42) AO A2&3, C1-3 11 66 months Synthes 2 (18) Synthes (2) Distal Radius Systems (4) Bridging ex-fixes Hand Innovation DVRs (6) Landgren et al. 50 48 (20-65) 14M 36F Single Trimed, VLP Hoffman type Frykman I-VII, 4 60 months Bridging ex-fix AO; A1-3 and C1-3, “irreducible”Xu et al. 30 Ex-fix: 45.3 18M 12F Single Variable +/- K wires Undisclosed AO-C 1 24 months (35-55) ORIF: 41.8 (21-56) Kapoor et al. 57 “Adults” 39M 18F Single “T-plate” or K wires Roger Henderson Frykman Unknown 48 months Bridging ex-fix VII & VIII

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ResultsFlexion/extension significantly

favoured ORIF, as seen in Figure 1, P=0.03.Pronation/supination and ulnar/radial devia-tion also favoured ORIF, but neither wasstatistically significant, SupplementaryFigures S2 and S3.

Expressed as the percentage deficit ofthe contralateral side, grip strength favouredORIF, as shown in Figure 2, but this was notstatistically significant P=0.83.

The radiographic parameters dorsal tilt,ulnar variance and radial inclination areshown in Supplementary Figures S4-6.Dorsal tilt and ulnar variance favouredORIF as shown in Supplementary FiguresS4 and S5, but neither was statistically sig-nificant; P=0.31 and 0.14 respectively.Radial inclination however was moreimproved with external fixation as seen inSupplementary Figure S8, but was not sta-tistically significant either; P=0.35.

When analysing complications, theresults favoured EF, as seen in Figure 3, butthis was not statistically significant a P-value of P=0.10. With regards infection inparticular; results suggested there were lessin ORIF, as shown in Supplementary FigureS7, and analysing malunion; the resultslightly favoured external fixation, as seenin Supplementary Figure S8, but neitherwere statistically significant. In relation toplate removal; Landgren 12 out of 26 platesremoved, Xu 14 out of 16 removed,Williksen 15 out of 29 removed, Kapoor notdocumented.

Landgren and Williksen were the onlytwo papers to express their functionalscores in the same manner usingQuickDASH. The result only slightlyfavoured ORIF, as seen in Figure 4 but wasnot statistically significant (P=0.59). Thetwo other papers used different subjectfunctional scoring systems; Kapoor usedSarmiento scoring;19 Xu used two scoringsystems: Gartland and Werley,37 and Greenand O’Brien.38 Kapoor reported; that out ofthe external fixation group 80% had good orexcellent results and 20% had fair or poorresults, whereas only 63% of the ORIFgroup had good or excellent results, 26%fair and 11% poor. Xu found ORIF had bet-ter Gartland and Werley and Green andO’Brien results compared to EF, howeverneither were statistically significant (asreported in the individual papers); P=0.88and 0.76 respectively.

DiscussionIn keeping with prior publications that

Article

Figure 1. Table and forest plot illustrating the meta-analysis for flexion/extension arc.

Figure 2. Table and forest plot illustrating the meta-analysis for grip strength deficit whencompared to the contra-lateral side.

Figure 3. Table and forest plot illustrating the meta-analysis for complication rates.

Figure 4. Table and forest plot illustrating the meta-analysis for functional scoringQuickDASH.

Table 3. Outcome summary.

Outcome Reduction method P-value

Flexion/Extension Arc ORIF 0.03Supination/Pronation Arc ORIF 0.12Radial Deviation/Ulnar Deviation Arc ORIF 0.47Grip Strength ORIF 0.83Dorsal Tilt ORIF 0.31Ulnar Variance ORIF 0.14Radial Inclination EF 0.35Total Complications EF 0.10Infection ORIF 0.34Mal-union EF 0.96


[Orthopedic Reviews 2019; 11:7809] [page 105]

document similar outcomes at a year, bothEF and ORIF outcomes remain similar inthe long term. Thus, it appears that the inva-sive open approach in the ORIF group doesnot seem to cause any deleterious effect inthe long term. Short term analyses haveshown that the EF group initially lagsbehind due to wrist immobilization, butquickly catches up with the ORIF group byas soon as 3 months after surgery.39,40 Eventhough ORIF in this analysis was signifi-cantly better for flexion/extension arc, thedifference of only 2 degrees is not clinicallymeaningful.

Grip strength was shown to have no sig-nificant difference between the ORIF andEF. It is notable that the Landgren suggest-ed ORIF was superior and Xu and Williksensuggested the opposite; however, within thestudies these also were not statistically sig-nificant with P-values of 0.3, 0.78 and 0.8respectively. Previous short term studieshave shown initially better grip strength inthe subacute period (6 weeks to 3 months)however the grip strength results seem toequilibrate by one year as shown in Wang etal.’s meta-analysis.39 This was believed todemonstrate that the longer immobilisationtime the external fixator group has toendure does not have a lasting effect ontheir objective functional ability. However,to conflict with this, another meta analysis;Cui et al., showed significantly better gripstrength in the early period in their externalfixator groups almost up to one year.However we note that there are several pub-lished papers that immobilised their ORIFsubjects and still found improved initialobjective measures of functionality; gripstrength and ROM.23,27,28

Radiographic parameters; dorsal tilt,ulnar variance and radial inclination wereall shown to not be of significant differencebetween the two treatment groups. Howeverdorsal tilt and ulnar variance favouredORIF, and radial inclination favoured exter-nal fixation. The large amount of malu-nions; five, in the Landgren article mayhave influenced this result.

Total complications in the long-termstudies reveal less in the external fixationgroup. This was not of statistical signifi-cance. It may be more appropriate to look atthe more short-term, <2 yr follow up, ran-domised control trials when reviewing theencountered complications. However, stillthere is no consensus; the meta analyses ofWalenkamp et al., Esposito et al., and Wanget al. found no significant difference inoverall complication rates between the twotreatment modalities.39-41 Within the anal-ysed studies there seemed to be a high pro-portion of plate removal; 41 of 71 reported(58%). A meta analysis by Cui et al. report-

ed a significant difference in favour ofORIF.42 When a sub analysis of infectionand malunion rates was performed; wefound no significant difference between thetreatment modalities. Aligned with this;three meta analyses looking at short termoutcomes found no statistical difference formalunion.39,40,42 But this was not the case forinfection. Wang et al. and Cui et al. bothfound that there was significantly increasedinfection rates in the external fixationgroup.39,42

When concerned with functional scor-ing, there was no statistically significantresult. However this meta-analysis favouredORIF (P=0.59). Kapoor and Xu’s methodsof data reporting was not amenable to metaanalysis but Xu found in favour of ORIF,and Kapoor; EF.

We recognise the limitations of thismeta analysis due to the small number ofpapers and the small sample size of 228subjects. Also, of note is that the follow uptimes were different for all papers; Xu 2years, Kapoor 4 years and Williksen andLandgren 5 years, for their final outcomeanalysis. This contributes a large amount ofheterogeneity to our meta analysis. Alsowithin the papers there were a number offracture types/classes and various methodsof ORIF were used, which has been identi-fied in other meta analyses,16,43 again con-tributing heterogeneity. The MetaP analysesassume the independence and same direc-tion of effects between individual ROMmeasures, which, however, cannot be veri-fied without the raw results of the originalstudies by Xu and Williksen.32,34 The inde-pendence assumption could lead to a small-er P-value (or a smaller standard error); thisfactor has been taken into account wheninterpreting the meta analysis results.

The studies in this meta analysis, aswith the meta analyses performed on theshort-term outcomes, compare multiple dif-ferent ORIF techniques with various jointbridging external fixation frames. The trendseems to be towards volar locking plates 28,we would recommend further randomisedcontrol trials be undertaken looking at boththe short term and long term outcomes oflocking volar plate fixation vs external fix-ation. There have been quite a few shortterm randomised control trials already butwith fairly small sample numbers and somealso compared a third method.22-25,27,28,44-46

ConclusionsIt appears that in the long term, ORIF

provides better range of motion than EFalthough this difference is not significant,

and there is no significant difference in gripstrength, subjective functional outcome orradiographic outcomes.

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