5
EVIDENCE-BASED MEDICINE REVIEWS Evidence-Based Hand and Upper Extremity Surgery Morad Askari, MD, Warren C. Hammert, MD, Noah Raizman, MD Plasma rich in growth factors in arthroscopic rotator cuff repair: a randomized, double-blind, controlled clinical trial. Ruiz-Moneo P, Molano- Muñoz J, Prieto E, et al. Arthroscopy. 2013;29(1):2e9. Level ITherapeutic study. Summary: Although arthroscopic repair of rotator cuff tear is a well-accepted practice, in some cases, the results are not satisfactory and tears may recur. The authors evaluate the effect of plasma rich in growth factors (PRGF) in improving the results of arthro- scopic rotator cuff repair through a randomized, double-blind, controlled clinical trial. Plasma rich in growth factors is a more pure form of platelet-rich plasma (PRP). Sixty-three patients underwent ar- throscopic rotator cuff repair with footprint coverage greater than 50% using double-row sutures technique. Thirty-two patients were randomly assigned to receive PRGF at the end of the repair. The injection was done both intra-tendinously and spread over the suture site under direct visualization. The groups were comparable based on the size of the tear. The outcome was assessed using modied UCLA scoring system at 1 year after repair and was compared with immediate preoperative scores between the group that received PRGF and the control. Patients were asked about their degree of satisfaction with their surgical repair. Anatomical evaluation of the repair was done using magnetic resonance imaging (MRI) arthrog- raphy at 1 year. Although both groups demonstrated an improve- ment in their scores compared with preoperative values, no signicant difference was seen between the 2 groups. Patient satisfaction was also similar. The number of cases with total healing, partial heal- ing, and retear based on assessment by MRI arthrography was similar between the 2 groups. Science: Platelet-rich plasma has been a topic of in- terest in orthopedic and upper extremity surgery as a potential tool to improve healing and regeneration. Growth factors and other biological mediators involved in the tissue repair process released by platelets in PRP preparation may provide more optimal outcomes. Modication of PRP preparation protocol allows for a lesser concentration of leukocyte and a higher concentration of growth factors and platelets and, thus, may result in less inammation as in PRGF. Currently, there are no convincing data to show any benet to using any preparation of PRP in conjunction with arthroscopic rotator cuff repair. Three prior prospective randomized open studies using PRP or some form of high platelet concentrates did not show any signicant benet to use of such preparations as seen in this report as well. The present study, other than a lack of a priori power analysis, was well planned, well controlled, and seemingly well executed, and the results show again no positive effect of PRP formulations on ro- tator cuff healing. The authors argue that a sample size calculation could not be made because they could not estimate an appropriate meaningful clini- cally important difference (MCID). This calculation is important and needed to determine adequate power for a study. They did have a primary outcome (UCLA score), and as is often seen in small trials, the study was underpowered to nd any differences in the secondary outcome measures; thus, the only real conclusion is that there was no obvious effect of PRGF on UCLA score. The authors did not provide error bars or condence intervals for MRI arthrog- raphy assessment of cuff healing. From the Division of Plastic & Reconstructive Surgery, Department of Surgery, Division of Hand & Upper Extremity Surgery, Department of Orthopedics, University of Miami Miller School of Medicine, Miami, Florida; School of Medicine and Dentistry, University of Rochester Medical School, Rochester, New York; and Orthopedic Medicine & Surgery, Washington, DC. Received for publication August 7, 2013; accepted in revised form August 11, 2013. No benets in any form have been received or will be received related directly or indirectly to the subject of this article. Corresponding author: Morad Askari, MD, Division of Plastic & Reconstructive Surgery, Department of Surgery, Division of Hand & Upper Extremity Surgery, Department of Orthopedics, University of Miami Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, 4th Floor, Miami, FL 33131; e-mail: [email protected]. 0363-5023/14/3902-0035$36.00/0 http://dx.doi.org/10.1016/j.jhsa.2013.08.101 392 r Ó 2014 ASSH r Published by Elsevier, Inc. All rights reserved.

Evidence-Based Hand and Upper Extremity Surgery

  • Upload
    noah

  • View
    215

  • Download
    1

Embed Size (px)

Citation preview

From the Division of Plastic & Reconstructive SurgeHand & Upper Extremity Surgery, Department of OSchool of Medicine, Miami, Florida; School of MRochester Medical School, Rochester, New York;Washington, DC.

Received for publication August 7, 2013; accepted

No benefits in any form have been received orindirectly to the subject of this article.

Corresponding author: Morad Askari, MD, DivisioDepartment of Surgery, Division of Hand & UppOrthopedics, University of Miami Miller School of1120 NW 14th Street, 4th Floor, Miami, FL 33131

0363-5023/14/3902-0035$36.00/0http://dx.doi.org/10.1016/j.jhsa.2013.08.101

392 r � 2014 ASSH r Published by

EVIDENCE-BASED MEDICINE REVIEWS

Evidence-Based Hand and Upper

Extremity Surgery

Morad Askari, MD, Warren C. Hammert, MD, Noah Raizman, MD

Plasma rich in growth factors in arthroscopicrotator cuff repair: a randomized, double-blind,controlled clinical trial. Ruiz-Moneo P, Molano-MuñozJ,PrietoE, et al.Arthroscopy.2013;29(1):2e9.

Level I—Therapeutic study.

Summary: Although arthroscopic repair of rotator cufftear is a well-accepted practice, in some cases, theresults are not satisfactory and tears may recur. Theauthors evaluate the effect of plasma rich in growthfactors (PRGF) in improving the results of arthro-scopic rotator cuff repair through a randomized,double-blind, controlled clinical trial. Plasma richin growth factors is a more pure form of platelet-richplasma (PRP). Sixty-three patients underwent ar-throscopic rotator cuff repair with footprint coveragegreater than 50% using double-row sutures technique.Thirty-two patients were randomly assigned toreceive PRGF at the end of the repair. The injectionwas done both intra-tendinously and spread over thesuture site under direct visualization. The groupswere comparable based on the size of the tear. Theoutcome was assessed using modified UCLA scoringsystem at 1 year after repair and was compared withimmediate preoperative scores between the group thatreceived PRGF and the control. Patients were askedabout their degree of satisfaction with their surgicalrepair. Anatomical evaluation of the repair was doneusing magnetic resonance imaging (MRI) arthrog-raphy at 1 year.

ry, Department of Surgery, Division ofrthopedics, University of Miami Milleredicine and Dentistry, University ofand Orthopedic Medicine & Surgery,

in revised form August 11, 2013.

will be received related directly or

n of Plastic & Reconstructive Surgery,er Extremity Surgery, Department ofMedicine, Clinical Research Building,; e-mail: [email protected].

Elsevier, Inc. All rights reserved.

Although both groups demonstrated an improve-ment in their scores compared with preoperativevalues, no significant difference was seen betweenthe 2 groups. Patient satisfaction was also similar.The number of cases with total healing, partial heal-ing, and retear based on assessment by MRIarthrography was similar between the 2 groups.

Science: Platelet-rich plasma has been a topic of in-terest in orthopedic and upper extremity surgery as apotential tool to improve healing and regeneration.Growth factors and other biological mediatorsinvolved in the tissue repair process released byplatelets in PRP preparation may provide more optimaloutcomes. Modification of PRP preparation protocolallows for a lesser concentration of leukocyte and ahigher concentration of growth factors and plateletsand, thus, may result in less inflammation as inPRGF.

Currently, there are no convincing data to showany benefit to using any preparation of PRP inconjunction with arthroscopic rotator cuff repair.Three prior prospective randomized open studiesusing PRP or some form of high platelet concentratesdid not show any significant benefit to use of suchpreparations as seen in this report as well.

The present study, other than a lack of a prioripower analysis, was well planned, well controlled,and seemingly well executed, and the results showagain no positive effect of PRP formulations on ro-tator cuff healing. The authors argue that a samplesize calculation could not be made because theycould not estimate an appropriate meaningful clini-cally important difference (MCID). This calculationis important and needed to determine adequate powerfor a study. They did have a primary outcome (UCLAscore), and as is often seen in small trials, the studywas underpowered to find any differences in thesecondary outcome measures; thus, the only realconclusion is that there was no obvious effect ofPRGF on UCLA score. The authors did not provideerror bars or confidence intervals for MRI arthrog-raphy assessment of cuff healing.

HAND AND UPPER EXTREMITY SURGERY 393

Implications: The present data in the literature do notsupport use of PRP or PRGF in repair of rotator cufftears.

Comparison of early mobilization protocolsin radial head fractures. Paschos NK, MitsionisGI, Vasiliadis HS, et al. J Orthop Trauma.2013;27(3):134e139.

Level I—Therapeutic study.

Summary: The optimal rehabilitation for simple radialhead fractures has yet to be determined. In a pro-spective, randomized, comparative study, the authorscompared 2 different protocols of early mobilization(immediate active mobilization vs active mobilizationafter 48 h of immobilization) to a protocol of delayedmobilization (mobilization after 7 d of splinting). All180 patients included had simple fractures with 64having some degree of displacement. Broberg andMorrey score, The American Shoulder and ElbowSurgeons-Elbow score, visual analog score, grip/pinch strength, as well as range of motion of theelbow were outcomes measured multiple times up to24 months. The assessor was blinded to treatmentprotocol.

Patients who underwent early active mobilizationafter 48 hours had the best outcomes. Both earlymobilization groups had earlier restoration of rangeof motion but pain scores in the first few days werebetter in the group mobilized after 48 hours. Differ-ence in range of motion deficit and grip/pinchstrength diminished among all 3 groups by week 12;yet, the group that was mobilized after 48 hours hadthe highest percentage of good/excellent functionalscores for the entire follow-up period.

Patients with nondisplaced simple fracturesreturned to preinjury status earlier than those withdisplaced simple fractures. In addition, displacementof greater than 4 mm or angulation greater than 30�

were associated with impaired outcome. The degreeof radial head involvement associated with impairedfracture outcome could not be clearly defined.

Science: There is increasing evidence rejecting theold paradigm of prolonged immobilization of simpleradial head fractures. Early mobilization can resultin earlier restoration of preinjury functional status byas early as week 4. Management of displaced simpleradial head fractures has not been well addressed ina large cohort. Nonoperative treatment of minimallydisplaced (2e5 mm) fractures has been associatedwith favorable outcome, although protocols havediffered substantially. In this report, the authors

J Hand Surg Am. r Vo

found starting early mobilization after 48 hours of restin a splint to provide superior outcomes. The mobi-lization was primarily flexion and extension of theelbow until day 8, at which point, pronation and su-pination exercises were introduced. The same proto-col resulted in favorable outcomes following simpledisplaced radial head fracture, although overalltiming to reach preinjury functional status was slowerand the degree of displacement was inversely relatedto favorable outcomes.Although no power analysis orsample size calculation was made here, the presenceof multiple significant comparisons using analysis ofvariance implies an adequate sample size. The authorsdid not indicate which measurement was their pri-mary outcome, which is necessary to determine theminimal important difference and ensure the study isadequately powered. Also, the authors make multiplecomparisons, and thus, the alpha error should havebeen corrected using the Bonferroni or similarmethod. This would have made fewer of the com-parisons “statistically significant” and is an issue thatideally would have been addressed by the authors.

Implications: This is a good study with some ques-tionable statistics that may limit interpretation of theresults. Overall, patients with simple radial headfracture with minimal or no displacement do betterwith early mobilization starting a few days after theinjury; this conclusion appears robust enough towithstand the limitations of using a Bonferroni orother correction. Seven days of immobilization isenough to result in less favorable short-term out-comes including more pain and later restoration ofpreinjury range of motion. In the long term, the dif-ferences are minimal.

Treatment of lateral epicondylitis with platelet-rich plasma, glucocorticoid, or saline: a random-ized, double-blind, placebo-controlled trial. KroghTP, Fredberg U, Stengaard-Pedersen K, et al. AmJ Sports Med. 2013;41(3):625e635.

Level I—Therapeutic study.

Summary: This report investigates the efficacy of 2prevalent injection therapies used in treatment oflateral epicondylitis (LE): glucocorticoid and platelet-rich plasma (PRP) injection, with a third cohort toserve as a control. A total of 60 patients were ran-domized into 3 treatment groups (saline, glucocorti-coid, and PRP). Both the patient and the evaluatingphysician were blinded to the treatment modalityduring the period of the study. The glucocorticoidinjection consisted of a 3-mL mixture of 40 mg of

l. 39, February 2014

394 HAND AND UPPER EXTREMITY SURGERY

triamcinolone mixed with lidocaine. PRP injectionconsisted of 3 to 3.5 mL of PRP prepared from 27 mLof whole blood centrifuged and prepared to anaverage of 8-fold platelet concentration. A similarvolume of saline was injected in the saline group.

Primary outcomes were the change in pain in-tensity based on the pain section of Patient-RatedTennis Elbow Evaluation (PRTEE) questionnaire at3 months, as well as change in functional disabilityusing the functional disability section of the PRTEE.In addition, ultrasound changes in color Dopplersignal and tendon thickness were recorded as well asinjection pain and other adverse events.

At 1 month, there was a statistically significantimprovement in the glucocorticoid group (decreasedpain and functional improvement), but at 3 months,there was no significant difference between groups.In addition, the ultrasound evaluation showed markedimprovement in tendon thickness and color Dopplersignal at 3 months in the glucocorticoid groupcompared with the other 2 groups. Injection pain wasworse with PRP injection; no other adverse eventswere noted in any group.

Science: This was a well-conducted and well-plannedrandomized and blinded clinical trial. Unfortunately, itwas difficult to provide follow-up beyond 3 monthsbecause the patient dropout rate increased to the pointthat, at 12months, only 16 of 60 patients were left in thestudy. These patients dropped out because of “unsatis-factory effect of initial treatment.” Interestingly, theglucocorticoid injection group, with the best outcome at1 month, had the highest dropout rate. Considering thisfact and that significantly better improvement withglucocorticoidwas noted at 1month, clearly the level ofimprovement was not adequate from the patient’sperspective. This may in part be explained by the gen-eral tendencyof the enrolled patients to prefer PRPuponenrollment and their being offered an opportunity at 3months to change to PRP treatment.

Overall, the study results reflect the alreadyexisting frustration in determining efficacy of anypopular injections in treatment of LE. These resultscontradict the results of a recent double-blind ran-domized controlled trial study with 100 subjectscomparing PRP with glucocorticoid in which PRPwas found superior at 12 months for patients with LE.A meta-analysis of injection therapy in treatment ofLE has found a small but significant improvementwith PRP compared with placebo.

Yet, this report (Krogh et al) is the only random-ized controlled trial in which the effect of PRP isdirectly compared with a placebo group. The study

J Hand Surg Am. r Vo

reinforces that glucocorticoid injection typicallyprovides short-term pain relief.

Fifty-eight percent of patients had received priorsteroid injections, and the mean duration of symp-toms was almost 2 years. Seventy percent of caseswere work-related. This creates a substantial sourceof potential bias, because it may have helped select apopulation of patients who had already failed steroidinjections (had their symptoms resolved, they wouldnot have enrolled in the study). This is a studypopulation that likely would have been offered sur-gical intervention at this point, given their symptomseverity. Also, as usual with PRP studies, the spe-cific formulation of PRP and platelet concentrationremains unstandardized, making the results lessgeneralizable. The fact that the placebo injectioninvolved repeated needling of the tendon originmakes it less a placebo than a third intervention.

Implications: The 3-month efficacy of glucocorticoidand PRP injection therapy is minimally different fromsaline injection. In a population of chronic LE pa-tients, the majority of whom had already failed priorinjections, glucocorticoid injection results in less painand better function over the first few months, butoverall, all treatments were ineffective in the shortterm and patient dropout precluded analysis of anylong-term outcomes. Ultrasonographically, theglucocorticoid injection led to improved (ie, lowered)vascularity and tendon thickness, but whether thispersisted beyond 3 months and whether this corre-lates to outcome remains unknown.

The value of the three-point index in predictingredisplacement of diaphyseal fractures of theforearm in children. Iltar S, Alemdaro�glu KB,Say F, et al. Bone Joint J. 2013;95-B (4):563e567.

Level III—Therapeutic study.

Summary: The authors enrolled and followed a pro-spective cohort of 76 patients with diaphyseal both-bone forearm fractures to test their hypothesis that3-point index (TPI) can be modified to assess reduc-tion and predict redisplacement of pediatric diaphysealforearm fractures. Patients had closed reduction andabove-elbow cast and followed at weekly intervals todetermine redisplacement, defined as further angula-tion of greater than 10� in any direction. They evalu-ated age, initial displacement, location of fractures,TPI, padding index, and whether anatomical reductionwas achieved. Anatomical reduction was achieved in41/76 (35 were considered acceptable, but notanatomical). 18/76 were noted to have redisplacement

l. 39, February 2014

HAND AND UPPER EXTREMITY SURGERY 395

at an average of 1.2 weeks, whereas alignment wasmaintained in 58. The only findings that were statis-tically significant for predicting redisplacementwere TPI (P < .001), padding index (P ¼ .006), andCanterbury index (P < .001).

Science: The ability to predict a fracture that has a highrisk of redisplacement can have important implications,potentially resulting in early intervention, whether thatinvolves changing/modifying the cast or early operativeintervention. The authors did not perform an a prioripower analysis, which is important in any prospectivestudy, but more essential in a randomized study todetermine a difference between 2 interventions. In thisprospective cohort, it can still be helpful in determiningwhether the redisplacement is due to chance or possiblythe result of another factor. The authors use multiplecomparisons, but their isolated findings predictive ofdisplacement likely make this irrelevant.

Implications: TPI, primarily used to predict stability/displacement for distal metaphyseal pediatric forearmfractures can also be used to predict redisplacementof pediatric diaphyseal both-bone forearm fractures.

Comparison of internal and external fixation ofdistal radius fractures: A meta-analysis of ran-domized controlled trials. Xie X, Xie X, QinH, et al.Acta Orthop. 2013; 84(3): 286e291.

Level of evidence: I.

Summary: The authors present a systematic review andmeta-analysis of randomized trials of internal fixationversus external fixation. Multiple smaller trials in thepast had shown limited or equivocal advantages ofinternal fixation for distal radius fractures, despite itspopularity as a treatmentmodality.Most previous trialshad also been underpowered to show effects in any oftheir secondary outcomemeasures. This meta-analysispools data from all these trials and demonstrates thatinternal fixation of any sort led to better Disabilitiesof the Arm, Shoulder, and Hand (DASH) scores at12 months, more anatomic reduction, and fewer com-plications overall than external fixation. The study alsoanalyzed volar plating separately and demonstratedthat volar plating led to earlier improvement in DASHscores at 3 and 6 months, but this evened out at 1 year.

Science: Meta-analysis is a set of statistical tools thattakes data frommultiple trials and analyzes it in a pooledfashion, based on a complex system of weightingof individual trials. It presupposes a systematic reviewto find only those trials that were appropriate. The pre-sent study performed and documented this very well,with appropriate inclusion and exclusion criteria. In

J Hand Surg Am. r Vo

particular, pediatric injuries were excluded, and onlythose randomized trials with a year of follow-up eval-uation and which compared some form of internal fix-ation to external fixation were included. DASH scorewas reported as the primary outcome measure. Theauthors justify every decision, from grading of com-plications and range of motion outcomes to their deci-sion to perform an independent analysis of volar platingversus external fixation. Of many hundred studiesreviewed, only 9made the final cut to be included in thestudy; not all of them reported DASH as an outcomemeasure, and there were many types of plates used, andmany of them are no longer routinely used. The studieswere analyzed for heterogeneity and appropriatelyweighted. The authors used a funnel plot for sensitivityanalysis (to evaluate whether 1 study predominantlyinfluenced the results of the overall meta-analysis) andthe Egger test to look for publication bias, and bothshowed no evidence of bias. From statistical and studydesign standpoints, there are no significant criticismsexcept for the lack of source material. In particular, nosource articles were sufficient to allow analysis ofpostoperative rehabilitation protocols or to allow strat-ification by patient age, both of which would be inter-esting to see.

Implications: This is the first meta-analysis to evaluatevolar locking plates versus external fixation, and,while it is not the first to look at internal versusexternal fixation, it is more recent and inclusive thanother meta-analyses. It clearly shows subtle butconsistent advantages to internal fixation in overalloutcome, anatomic reduction, and complication rate,and, in volar plating, an earlier improvement infunction and motion, although this may decline overthe course of a year. While external fixation is lesspopular than it once was as a stand-alone treatment, itremains an important tool in complex fractures. Thiswell-performed study is an excellent demonstrationof the power of systematic review and meta-analysisto provide more convincing evidence by combiningthe results of several equivocal, inconclusive, or un-derpowered trials.

Carpal tunnel release: a randomized comparison ofthree surgical methods. Larsen MD, Serensen AI,Crone KL, et al J Hand Surg Eur Vol. 2013;38(6):646e650.

Level I—Therapeutic study.

Summary: The authors compared 3 methods of carpaltunnel release (CTR): (1) endoscopic (ECTR), (2)classic open with incision extending proximal to thewrist crease (OCTR) measuring about 7 cm, and (3)

l. 39, February 2014

396 HAND AND UPPER EXTREMITY SURGERY

short-incision open technique using a 3-cm incision inthe palm only. A total of 90 patients diagnosed withCTS based on 3 months of clinical symptoms alongwith abnormal EDS were randomly divided among 3treatment groups. Follow-up was at 1, 2, 3, 6, and 12months with blinded observers. Outcomes measuredincluded pain, grip strength, and range of movement.

Overall, the authors reported no difference in painand improvement in paresthesias between the 3groups but an earlier trend (weeks 1, 2, and 3) inreturn of grip strength and range of movement inECTR group. By 6 weeks, the OCTR group hadcaught up with the ECTR group in grip strength and,by 24 weeks, no difference was present among the 3groups. Days missed from work were least withECTR group (6 d), followed by OCTR group (16 d),and short-incision open technique (20 d). No majorcomplications were reported for any of the groups,but there were 2 cases of transient neurapraxia in theendoscopic group.

Science: The report echoes results similar to studies inthe literature, although none had included a shortincision group along with a classic incision group inaddition to an ECTR group. Overall, there is a trendtoward earlier return to work with the endoscopictechnique but a higher likelihood of transient mediannerve branch neurapraxia with ECTR as shown by the2007Cochrane database. In general, smaller incision inthe OCTR is associated with earlier return to work.Remaining outcomes such as resolution of neu-rapraxia, degree of pain, and improvement in gripstrength are similar beyond 3 months. ECTR has beenshown to be more cost effective than OCTR, depend-ing on the incidence of major complications. Thus,even with a slightly higher incidence of median nerveinjury, ECTR becomes less cost effective than OCTR.

From a statistical point of view, the authors choseto use the Kruskal-Wallis technique, which is a non-parametric alternative to a 1-way analysis of variance.

J Hand Surg Am. r Vo

It is not made clear in the paper why the authorsthought their data were nonparametric (ie, not nor-mally distributed), but the use of Kruskal-Wallisgrossly decreases the power of the comparison. Theauthors did not indicate their primary outcome andminimal important difference to ensure the studyhas adequate power. There was no a priori poweranalysis given to justify the small sample sizes in thestudy, and taken together, it is likely that the studywas significantly underpowered to show a differencein any of the outcome measures used. There were 2patients in the ECTR group who were converted toopen release because of “tightness” of the carpaltunnel or inability to visualize the distal extent ofthe transverse carpal ligament. These patients weredropped from the study. These patients should befollowed with intention to treat analysis (dataanalyzed in initial group) or switched (data analyzedwith new group, in this case, the OCTR group). Thebest method is debatable, but it is clearly important tofollow these patients and include them in the finaldata rather than dropping from the study. Adequateattempts at blinding and randomization were made,although, necessarily, this was a single-blind study.

Implications: ECTR may offer earlier return to work incomparison with the open techniques. Beyond 3months, there is minimal difference in different CTRtechniques. A small-incision OCTR should not beconfused with a miniopen or minimally invasivetechnique using a slide, and this popular surgicaloption was not tested. Overall, this was an under-powered study with equivocal results. Whereas itmay be useful when combined with other studies in asystematic review or meta-analysis, it provides littleclinical guidance. As stated in the AAOS CPG,complete division of the transverse carpal ligament isthe most important aspect of CTR and the means bywhich this occurs may be irrelevant assuming thereare no complications.

l. 39, February 2014