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J Shoulder Elbow Surg (2012) 21, 456-463

1058-2746/$ - s

doi:10.1016/j.jse

www.elsevier.com/locate/ymse

Open debridement and radiocapitellar replacementin primary and post-traumatic arthritis of the elbow:a multicenter study

Giuseppe Giannicola, MDa,*, Renzo Angeloni, MDb, Alberto Mantovani, MDc,Enrico Rebuzzi, MDd, Giovanni Merolla, MDe, Alessandro Greco, MDa,Federico M. Sacchetti, MDa, Italo Nofroni, PhDf, Gianluca Cinotti, MDa,Franco Postacchini, PhDa

aDepartment of Orthopaedic Surgery, ‘‘Sapienza’’ University of Rome, Rome, ItalybDepartment of Orthopaedic Surgery, C.T.O. Careggi Hospital, Firenze, ItalycUpper Limb Unit, Mater Salutis Hospital, Legnago, ItalydDepartment of Orthopaedic Surgery. Treviso-Oderzo Hospital, Treviso, ItalyeUnit of Shoulder and Elbow Surgery D, Cervesi Hospital, Cattolica, ItalyfDepartment of Public Health, ‘‘Sapienza’’ University of Rome, Rome, Italy

Background: Postmortem and clinical studies have shown an early and prevalent involvement of the radio-humeral joint in primary and secondary arthritis of the elbow. The lateral resurfacing elbow (LRE) pros-thesis has recently been developed for the treatment of lateral elbow arthritis. However, few data have beenpublished on LRE results.Materials and methods: A prospective multicenter study was designed to assess LRE preliminary results.There were 20 patients (average age, 55 years). Preoperative diagnosis were primary osteoarthritis in 11and post-traumatic osteoarthritis in 9. All patients underwent open debridement and LRE prosthesis.Patients were evaluated preoperatively and postoperatively with the Mayo Elbow Performance Score(MEPS), modified American Shoulder Elbow Surgeons (m-ASES) elbow assessment, and the QuickDisabilities of the Arm, Shoulder and Hand (Quick-DASH). Mean follow-up was 22.6 months.Results: At the last follow-up, the mean improvement of MEPS and m-ASES was 35 (P ¼ .001) and 34(P ¼ .001) respectively; the average Quick DASH decreased by 29 (P ¼ .001). Average range of motionwas improved by 35� (P ¼ .001). MEPI results were excellent in 12 patients, good in 2, and fair and poor in3 each. Mild overstuffing was observed in 5 patients, and an implant malpositioning in 3. The implantsurvival rate was 100%.Conclusion: LRE showed promising results in this prospective investigation. Most patients had anuneventful postoperative course and have shown a painless elbow joint, with satisfactory functionalrecovery at short-term follow-up. Further studies with longer follow-up are warranted.

s not require Institutional Review Board or Ethical

oval for this type of study. However, each author’s insti-

the human protocol for this investigation, and all inves-

nducted in conformity with ethical principles of research.

*Reprint requests: Giuseppe Giannicola, MD, Via Emilio Repossi 15,

C.A.P. 00158 Roma, Italy.

E-mail address: giannicola.g@tin.it (G. Giannicola).

ee front matter � 2012 Journal of Shoulder and Elbow Surgery Board of Trustees.

.2011.08.071

Open debridement and radiocapitellar replacement 457

Level of evidence: Level IV, Case Series, Treatment Study.� 2012 Journal of Shoulder and Elbow Surgery Board of Trustees.

Keywords: Elbow; arthritis; osteoarthritis; replacement; radio-capitellar; lateral resurfacing

The lateral resurfacing elbow (LRE) prosthesis has beenrecently introduced in the treatment of degenerative andinflammatory conditions of the elbow.26 The potentialindications of this device, designed to exclusively replacedthe lateral compartment, emerged from pathologic investi-gations showing that primary and secondary degenerativechanges of the elbow may involve the joint asymmetrically,the radiohumeral joint being the compartment mostfrequently damaged.2,7,13,15,25,28 Such degenerative changeswere present in adult patients and often remained confinedto the lateral compartment throughout life.13 Further clin-ical studies have highlighted the prevalent involvement ofthe lateral compartment.22,23,27 In particular, Rajeev andPooley27 reported that in a series of 117 patients com-plaining of lateral elbow pain unresponsive to conservativetreatments, 60 showed arthritic changes limited to theradiohumeral joint. Furthermore, the articular surfaces ofthe lateral compartment appear to be more vulnerable totrauma, such as fractures of the radial head, fractures of thehumeral capitellum, terrible triad injury, and Monteggia-like lesion, which often cause post-traumatic degenerativechanges of the radiocapitellar joint.18,21

On the basis of these findings, a new resurfacing pros-thesis was designed aimed at replacing only the radio-humeral joint in patients showing primary and secondaryosteoarthritis with asymmetrical involvement of the artic-ular surface.26 After the preliminary results reported by theauthor,26 the clinical outcomes of radiocapitellar replace-ment were evaluated in 3 patients who had a different typeof prosthesis,16 and in 1 with a malunion after humeralshear fracture.11 We report the results of LRE in a largerseries of patients who were included in a prospectivemulticenter study analyzing short-term outcomes of opendebridement and LRE in the treatment of primary and post-traumatic osteoarthritis of the elbow.

Materials and methods

Selection and characteristics of the patients

From November 2006 to March 2010, 24 open debridement andLRE procedures were performed in 5 Departments of Upper LimbSurgery: 19 total LRE and 5 hemi-LRE in which only the humeralcomponent was implanted.

A software program was developed to standardize managementand result evaluation, aswell as to facilitate communication and dataexchange among surgeons. The software was available on-line and

divided into 6 sections: the first 5 sections included data collection,patient details, and clinical, radiologic, and surgical details, andsection 6 included tables for clinical and radiologic follow-up.

Of the 24 patients, 4 were lost to follow-up (dropout, 16.6%);thus, the study included 17 patients with total LRE and 3 withhemi-LRE. There were 12 men and 8 women, with an average ageof 55 years (range, 31-73 years). All study patients had from mildto severe pain and stiffness, essentially due to degenerativechanges in the lateral compartment associated with ulnohumeralosteophytosis.

The operating diagnosis was primary osteoarthritis in 11patients and post-traumatic osteoarthritis in 9. In 14 patients,a conservative treatment with physiotherapy and nonsteroidal anti-inflammatory drugs for more than 6 months had not been bene-ficial. In 6 patients, intra-articular cortisone injections wereadministered because of severe pain, with only temporary andpartial benefit. No elbow joint mobilizations under anesthesiawere performed before surgery.

None of the 11 patients with primary osteoarthritis hadundergone a previous surgical procedure, whereas 2 of the 9patients with post-traumatic osteoarthritis had undergone 1 ormore operations. In particular, 1 patient had undergone arthro-scopic debridement, without benefit, and another patient hadundergone multiple open debridements, with recurrence of painand stiffness.

All patients underwent preoperative clinical and imagingevaluations with radiographs and computed tomography scanning.Clinical evaluation was accomplished with the Mayo ElbowPerformance Score (MEPS), the modified American Shoulder andElbow Surgeons (m-ASES) score, and the Quick Disabilities ofthe Arm, Shoulder and Hand (Quick DASH) score.4,19,24 TheMEPS considers intensity of pain, range of motion (ROM), jointstability, and ability to perform activities of daily life (score, 0 to100). The Mayo Elbow Performance Index (MEPI) classifiesresults as excellent, good, fair, and poor. The modified ASES andthe Quick DASH consider the intensity of pain during dailyactivities and the ability to accomplish such tasks.

Exclusion criteria of LRE implant were:

1. recent or active infections;2. presence of severe neuromuscular deficit, which could jeop-

ardize elbow function, particularly of biceps and tricepsbrachii muscles;

3. severe reduction of wrist and hand function;4. severe bone loss of the posterior aspect of the lateral column,

which could compromise the stability of the humeralcomponent;

5. severe deformity of the radiohumeral and proximal radioulnarjoint, which could affect the implant stability of both LREcomponents; and

6. marked wear of the medial compartment (ulnohumeral joint)in patients aged older than 60.

458 G. Giannicola et al.

Surgical technique

Patient positioning and the surgical approach were chosendepending on the type of open debridement required. A lateralposition was used in 13 patients, 2 were placed prone, and theremaining 5 were placed supine with the arm supported on a table.The arm was exsanguinated, and a pneumatic tourniquet wasapplied at 250 mm Hg for a maximum of 2 hours.

A posterior midline incision was made in 18 patients, whereasa lateral approach was used in the remaining patients. In 15patients, deep dissection was performed using the transtricipitalapproach, as described by Pooley.26,3 Briefly, a posterior midlineincision was performed, and the ulnar nerve was exposed andprotected during the remainder of the procedure.

Deep dissection was carried out through the triceps aponeurosisand the intermuscular aponeurosis, separating the lateral head ofthe triceps from the medial and long head. The anconeus and lateralhead of the triceps were retracted laterally as a single unit, and theintermuscular aponeurosis was divided 2 cm apart from the olec-ranon. The medial and long head of triceps was retracted mediallyand the posterior capsule excised. The lateral collateral ligamentwas partially released from its capitellar origin, and the elbow wasdislocated by flexing it in valgus and opening the joint with a leverplaced over the tip of the coronoid and the radial head.

In the remaining 5 patients, an extensive posterolateralapproach, as described by Kocher,20 was used. In these cases,a proximal detachment of the lateral collateral ligament wasperformed to expose the external compartment adequately. At theend of the surgical procedure, the ligament was reattached throughtransosseous sutures (in 1 patient) or with anchors (in 4 patients).

The ulnar nerve was exposed when the transtricipital accesswas used, when a marked elbow stiffness was present, and inpatients with preoperative evidence of ulnar neuropathy. Anteriorand posterior capsule, loose bodies, and ulnohumeral osteophyteswere removed; ligament insertion release and debridement of theanterior and posterior fossae were performed. After debridement,ROM improvement was usually achieved and the LRE wasimplanted. All patients had marked cartilage wear limited to thelateral compartment, along with normal appearances of articularcartilage of the medial compartment.

The operating technique for the LRE implant started withimplantation of the humeral component, followed by the radialcomponent. The operation was performed in accordance with theguidelines described by Pooley.26

Patient details, including age, sex, side, diagnosis, surgicalapproach, and type of implant, are reported in Table I.

Postoperative management

At the end of surgery, 2 drains were placed (1 intra-articular and 1subcutaneous) for 48 hours. The elbow was immobilized inextension with a plaster cast for 24 to 48 hours in a raised position,and cryotherapy was applied. Adequate analgesic treatment wasprescribed to all patients.

The postoperative rehabilitation program depended on the typeof debridement performed. The patientswere encouraged to performactive and passive exercises beginning from postoperative day 2:

1. when the Kocher approach was used, active assisted elbowflexion and extension without limitation were performed;

2. limitation to 90� of active and passive flexion for the first3 weeks and passive gravity-assisted elbow extension forthe first 5 weeks were permitted in patients on whom thetranstricipital approach was performed, to preserve tricepshealing;

3. all patients were permitted active and passive assistedpronation and supination at 90� of flexion in the first 4 weeks.

During the intervals between physiotherapy, the patient worea hinged splint or a resting splint, and cryotherapy was applied.Patients were usually discharged on postoperative day 3 (range,2-7 days).

In 11 patients, a 90� resting splint was used for 2 weeks afterdischarge and removed only for physiotherapy. In the remaining 9patients, an unlocked hinged brace was used all day; at night thesplint was locked alternately in maximum extension and inmaximum flexion for the following 6 weeks. In 9 patients,continuous passive motion was used for about 1 month. Allpatients performed rehabilitation therapy: 12 were assisted bya physiotherapist, and 8 performed self-managed physiotherapy inaccordance with the surgeons’ indications. Activities of daily lifewere allowed beginning after 8 weeks. Strenuous activities werepermitted after 4 to 6 months.

Follow-up

All patients underwent their last clinical and radiographic follow-up between June and October 2010. The mean follow-up was 22.6months (range, 6-47 months). Clinical evaluation was performedusing MEPS, the m-ASES, and the Quick DASH. Implant posi-tioning was evaluated using preoperative and postoperativeradiographs and those taken at the last follow-up. On plain films,we evaluated radiolucent lines and osteolysis, component posi-tioning and size, presence of overstuffing, and quality of reductionof the prosthetic components.

For statistical analysis, we used SPSS 13.0 software (SPSS Inc,Chicago, IL, USA). Mean, median, and standard deviation (SD)were calculated. The nonparametric Wilcoxon signed-rank testand the Mann-Whitney test were used for comparison of preop-erative and postoperative results, as well as age, sex, diagnosis,preoperative ROM, surgical approach, and postoperative rehabil-itation program. The level of significance was set at P � .05.

Results

Preoperative clinical evaluation

The mean MEPS score was 50 (range, 30-85; SD, 15.9) andthe mean Quick DASH score was 52 (range, 9-89; SD,21.7). The average M-ASES score was 49 (range, 5-86;SD, 23.5), and the mean pain score was 21 (range, 5-48;SD, 12.6). Extension averaged 37� (range, 10�-70�; SD,16.4�) and flexion averaged 100� (range, 30�-140�; SD,25.2�). The average preoperative arc of movement was 65�

(range, 0�-130�; SD, 25.9�). Pronation averaged 53� (range,0�-85�; SD, 31�), and supination averaged 52� (range, 0�-85�; SD, 31.5�). According to the MEPI, preoperative statuswas poor in 15 patients, fair in 3, and good in 2.

Table I Details of the patients

Pt Age Sex Side Diagnosis Surgical approach Total/hemi-LRE)

1 54 M R OA Transtricipital Total2 56 M R PTOA radial head fracture Kocher Total3 49 M R OA Kocher Total4 31 F L PTOA humeral capitellum fracture Transtricipital Hemi5 57 M L OA Kocher Total6 49 M L PTOA radial head fracture Kocher Total7 53 M R OA Transtricipital Total8 55 M R OA Transtricipital Total9 44 M R PTOA radial head fracture Transtricipital Total

10 71 M R OA Transtricipital Total11 60 F R OA Transtricipital Total12 67 F R PTOA radial head fracture Kocher Total13 54 F L PTOA humeral capitellum fracture Transtricipital Hemi14 73 F R PTOA distal humeral (C3) fracture Transtricipital Total15 55 F R PTOA humeral capitellum and olecranon fracture Transtricipital Hemi16 61 F R OA Transtricipital Total17 54 M R OA Transtricipital Total18 59 M R OA Transtricipital Total19 35 F L OA Transtricipital Total20 68 F R PTOA humeral capitellum and trochlea fracture Transtricipital Total

F, female; L, left; M, male; OA, primary osteoarthritis; PTOA, post-traumatic osteoarthritis; R, right.) Total: the humeral and radial components were both implanted; hemi: only the humeral component was implanted.

Open debridement and radiocapitellar replacement 459

Clinical evaluation at last follow-up

TheMEPS averaged 85 (range, 50-100; SD, 17.1) and QuickDASH averaged 23 (range, 0-73; SD, 25). The averageM-ASES score was 83 (range, 55-100; SD, 16.7), witha mean pain score of 44 (range, 20-50; SD, 8.8). Extensionaveraged 25� (range, 0�-65�; SD, 19.5�), and flexion aver-aged 125� (range, 25�-150�; SD, 27.8�). The average arc ofmovement in extension-flexion was 95� (range, 0�-150�; SD,34.0�). The mean pronation was 70� (range, 15�-85�; SD,17.9�) and supination was 75� (range, 35�-85�; SD, 14.9�).According to MEPI, results were excellent in 12 patients,good in 2, and fair and poor in 3 patients each.

Good elbow stability was found in all but 3 patients. Ina 75-year-old patient with Parkinson disease, operated onfor primary osteoarthritis and chronic elbow instability,a recurrent instability occurred leading to dislocation of theprosthetic component. The patient refused further surgicaltreatment. In the remaining 2 patients, mild varus andvalgus instability was found, respectively; however, bothpatients reported good results at the last follow-up.

Statistical analysis

MEPS and m-ASES increased 35 and 34 points, respec-tively, whereas the Quick DASH was decreased by anaverage of 29 points. Differences were statistically signif-icant (P ¼ .001). Intensity of pain decreased by 23 pointsaccording to m-ASES. The difference between preoperative

and postoperative intensity of pain was statistically signif-icant (P ¼ .001). An increase in extension of 10� (P ¼.014), in flexion of 25� (P ¼ .001), and in arc of movementof 30� (P ¼ .001) was observed. The comparison betweenpreoperative and postoperative values and between preop-erative and postoperative scores is shown in Figure 1.

No difference was observed among patients with totalLRE and hemi-LRE. No statistical difference was observedamong patients with primary and post-traumatic osteoar-thritis. Other variables, such as age, sex, type of surgicalaccess, type of immobilization, and severity of stiffness, didnot influence the clinical results.

Radiographic evaluation at final follow-up

The implant survival rate was 100% after a mean follow-upof 22.6 months. Radiographic evaluation showed goodpositioning of the implant in all but 3 patients; in the latter,the humeral component was positioned too horizontally in2 patients (Fig. 2) and too proximally in 1. In the first 2patients, the implant malpositioning was associated with anunsatisfactory clinical outcome due to extrinsic stiffness.The third patient had good range of motion and mildpositive valgus stress.

In 5 patients, a slight overstuffing was present (Fig. 3).Four of these patients reported satisfactory clinical outcomes,whereas 1 patient, showing an oversizing of the humeralcomponent, had a poor outcome. No patients showed peri-prosthetic radiolucent lines. In 2 patients with post-traumatic

Figure 1 Results are shown for the preoperative and post-operative Mayo Elbow Performance Score (MEPS), modifiedAmerican Shoulder and Elbow Surgeons (m-ASES), QuickDisabilities of the Arm, Shoulder and Hand (Q-DASH) and arc ofmovement (range of motion [ROM]). )Significant differencebetween the preoperative and postoperative value.

Figure 2 Postoperative anteroposterior x-ray image demon-strates the horizontal position of the humeral component.

Figure 3 Postoperative anteroposterior x-ray image of a 60-year-old housewife 19 months after surgery shows slight over-stuffing of components, with mild opening of the lateral side of theulnohumeral joint (white arrows).

460 G. Giannicola et al.

osteoarthritis, the postoperative osteopenia around thehumeral stem had disappeared at the last follow-up.

Complications

Of the 20 operated-on patients, 16 were satisfied with thesurgical treatment (Fig. 4). Of the 4 unsatisfied patients

(20%), 3 had a recurrent elbow stiffness and 1 had a post-operative worsening of ulnar neuropathy. Two of the 3patients with elbow stiffness showed an excessively hori-zontal positioning of the humeral component; however, thisdid not appear to be related to the poor outcome.

One of the 2 patients was reoperated on for arthrolysisand removal of heterotopic ossifications (HO) 9 monthsafter LRE implant. At the last follow-up, the patient com-plained of persistence pain and limitation of daily activities,both of which were resistant to medical and physiother-apeutic treatment.

The second patient developed an extension stiffness of50� caused by posterior HO. Because he complained oflimitations in working and daily activities, he was reoper-ated on 12 months after surgery for soft tissue releaseand HO removal. He reported a good result at the lastfollow-up.

The third patient developed a flexion/extension anky-losis of the elbow associated with ulnar nerve neuropathy.The patient underwent open debridement and ulnar nerveneurolysis. The last patient, who reported a postoperativeworsening of ulnar nerve neuropathy, refused any furthersurgical treatment.

Figure 4 (A, B) Preoperative x-rays images demonstrate primary degenerative osteoarthritis in a 54-year-old manual worker. (C, D)Postoperative x-ray images after extensive open debridement, fenestration of olecranon fossa, and implant of the lateral resurfacing elbowshow the joint space has been maintained and is symmetrical. Patient demonstrates final elbow range of movement 18 months after surgery:(E) flexion, (F) extension, (G) supination, and (H) pronation.

Open debridement and radiocapitellar replacement 461

Discussion

Degenerative and inflammatory conditions frequentlyinvolve the elbow joint asymmetrically, with a prevalentand early involvement of the lateral compartment.2 As earlyas 1967, postmortem studies highlighted that the firstdegenerative changes often involve the humeral capitellumand the radial head.13 Over time, other investigationsconfirmed these findings7,12,15,23,25,27,28 and showed thatlateral degenerative changes may become clinically evidentin patients in their late 40s or early 50s and be responsiblefor disabling elbow pain resistant to conservative treatmentand nonreplacement procedures.1,10,22,31 Indeed, in cases ofprimary and post-traumatic osteoarthritis of the lateralcompartment, surgical procedures including synovectomyor open or arthroscopic debridement, or both, areoften associated with poor surgical outcomes.9 However,total elbow arthroplasty (TEA) has limited indicationsin young patients with high functional demands and inthose showing no or moderate changes in the medialcompartment.6,14,16,29,30

On the basis of these observations, Pooley26 conceivedthe LRE and first reported the preliminary results in 10patients after a maximum follow-up of 18 months. TheMEPI was excellent in 6 patients, good in 3, and fair in 1. Adeep infection in 1 patient required removal of thecomponents; another patient, who reported a fall in theearly postoperative period, required surgery for a tricepsmuscle dehiscence. A subsequent case report on LRE ina patient with malunion after a humeral shear fractureshowed a good result at the short-term follow-up.11

Because to our knowledge these are the only reports onpatients treated with LRE, we planned a multicenter studyaimed at analyzing the preliminary results in a larger seriesof patients, considering the rare indication of this pros-thesis. The results seem to confirm the validity of opendebridement associated with LRE in pain resolution andimplant survival. In our series, 85% of the patients hada complete resolution or marked reduction of pain associ-ated with a significant improvement in elbow function, theaverage postoperative increase of ROM being 35� inextension/flexion, and 16 of the 20 patients were satisfiedwith the surgical procedure. We believe these results are ofparticular interest because the average age in our series was55 years and most of the patients were able to resume theirwork or sport activities, or both, previously abandonedbecause of pain and joint stiffness.

Radiographic results were also encouraging: no implantloosening was observed after an average of 23 months, andwe found no radiographic changes in the 7 patients witha follow-up exceeding 3 years. These data are consistentwith those reported by Pooley,26 who found an implantsurvival rate of 98%.

The radiographic evaluation showed that a correctpositioning of the humeral component is more difficult toachieve than of the radial component. The humeralcomponent was too horizontal or proximal in 3 patients,and prosthesis oversizing was observed in another patient.A slight overstuffing was found in 25% of patients, withmoderate opening of the lateral side of the ulnohumeraljoint. Although these complications did not influence theshort-term results, overstuffing may cause overloading of

462 G. Giannicola et al.

the inner part of the ulnohumeral joint and eventually leadto degenerative changes in the medial compartment.

To avoid overstuffing, it is essential to ream the humeraland radial surfaces adequately, and after the trial compo-nents are positioned, to check the ulnohumeral joint bydirect visualization or fluoroscopy. If an opening of thelateral part of the ulno-humeral joint is found or an asym-metric joint is seen on fluoroscopy, an overstuffing is likelyto be present. Overstuffing is most frequently caused by anincorrect positioning of the humeral component due to thelack of reliable anatomic landmarks. In addition, weobserved that, especially in young patients with good bonestock, the layer of hydroxyapatite covering the implantmight cause a mild mismatch between the trial and defin-itive component, which may result in overstuffing. Thesefindings suggest implant malpositioning could be reducedby improving the accuracy of surgical instrumentation.

Although no patient underwent LRE revision, webelieve that LRE preserves bone stock and does notjeopardize future surgical procedures, such as interpositionarthroplasty or TEA. This may be of particular relevance inyoung patients and in those with inflammatory conditionsin whom a progression of degenerative changes in theelbow may be expected. Unlike TEA, LRE may also beindicated in young and active patients because it is anunlinked resurfacing prosthesis of the lateral compartment,and the use of the limb does not seem to be limited by theprosthesis. It should also be considered that compared withcapitellectomy, LRE restores the function of the lateralcompartment and allows recovery of elbow stability.5,8,17

This is particularly important in patients with high func-tional demands, such as manual workers; in our series,45% of the operated-on patients were manual workers, andthey all returned to their preoperative jobs, without limi-tations, 6 months after surgery. No clinical and radio-graphic signs of loosening were observed in any of thesepatients.

This study has some limitations, including the variabilityrelated to a multicenter study, for example, differentsurgeons and preoperative diagnoses (primary or post-traumatic osteoarthritis), which may require differentsurgical procedures and different postoperative manage-ment. In addition, although this is the largest series of LREanalyzed so far, a limited number of patients were analyzedafter short-term follow-up.

Conclusions

The present investigation has shown that open debride-ment and radiocapitellar replacement may provideencouraging short-term results. We believe that futuredevelopment of the device may broaden its surgicalindications in traumatic and degenerative-inflammatoryelbow conditions and concomitantly reduce the need for

TEA in young patients. Further studies with longerfollow-up are warranted.

Disclaimer

The authors, their immediate families, and any researchfoundations with which they are affiliated have notreceived any financial payments or other benefits fromany commercial entity related to the subject of this article.

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