Quantitative review of operative management of ...

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Keywords: hallux rigidus/arthrodesis/cheilectomy/osteotomy/arthroplasty. Accepted: November 24, 2010. British Medical Bulletin 2011; 1–24. DOI:10.1093/bmb/ ...
Quantitative review of operative management of hallux rigidus Nicola Maffulli †*, Rocco Papalia ‡, Alessio Palumbo ‡, Angelo Del Buono ‡, and Vincenzo Denaro ‡ †

Centre for Sports and Exercise Medicine, Barts and The London School of Medicine and Dentistry, Mile End Hospital, 275 Bancroft Road, E1 4DG London, UK, and ‡Department of Orthopaedic and Trauma Surgery, Campus Biomedico University of Rome, Via Alvaro del Portillo, Rome, Italy

Introduction: Surgical techniques for the management of hallux rigidus include cheilectomy, Keller resection arthroplasty, arthrodesis, Silastic implantation, phalangeal or metatarsal osteotomy, capsular arthroplasty, partial or total joint replacement, interposition arthroplasty. However, the optimal management is controversial. Sources of data: We performed a comprehensive search of CINAHL, Embase, Medline and the Cochrane Central Registry of Controlled Trials, from inception of the database to 2 November 2010. Sixty-nine articles published in peer reviewed journals were included in this comprehensive review. Areas of agreement: Cheilectomy and first metatarsal or phalangeal corrective osteotomy may provide better outcome for patients with early and intermediate hallux rigidus (Stages I–II), while arthrodesis or arthroplasty are indicated to manage more severe conditions. The Coleman Methodology Score showed great heterogeneity in terms of study design, patient characteristics, management methods and outcome assessment and generally low methodological quality. Areas of controversy: Definitive conclusions on the use of these techniques for routine management of patients with hallux rigidus are not possible. Given the limitations of the published literature, especially the extensive clinical heterogeneity, it is not possible to compare outcomes of patients undergoing different surgical procedures and determine clear guidelines.

*Correspondence address. Centre for Sports and Exercise Medicine, Barts and The London School of Medicine and Dentistry, Mile End Hospital, 275 Bancroft Road, E1 4DG London, UK. E-mail: n.maffulli@ qmul.ac.uk

Growing points: To assess whether benefits from surgery, validated and standardized measures should be used to compare the outcomes of patients undergoing standard surgical procedures. Research: There is a need to perform appropriately powered randomized clinical trials of using standard diagnostic assessment, common and validated scoring system comparing reported outcomes and duration of follow-up .2 years.

Keywords: hallux rigidus/arthrodesis/cheilectomy/osteotomy/arthroplasty Accepted: November 24, 2010

British Medical Bulletin 2011; 1–24 DOI:10.1093/bmb/ldq041

& The Author 2011. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: [email protected]

N. Maffulli et al.

Introduction Hallux rigidus is a common and progressive painful osteoarthritis of the first metatarsophalangeal joint (MTPJ) with reduced range of motion (ROM) and function.1 – 5 Surgery is usually indicated for patients unresponsive to conservative management, including nonsteroidal anti-inflammatory and cortico-steroid drugs, physiotherapy, activity modification, shoe modifications. Surgical techniques for management of painful hallux rigidus include cheilectomy, Keller resection arthroplasty, arthrodesis, silastic implants, dorsiflexion phalangeal osteotomy, metatarsal osteotomy, capsular arthroplasty, joint replacement. Though arthrodesis of the MTPJ is considered the gold standard in the management of severe hallux rigidus, cheilectomy and first metatarsal or phalangeal corrective osteotomy may provide better outcome at earlier stages.4,6 – 9 Cheilectomy involves the alleviation of the osseous impaction of the proximal phalanx and metatarsal head through debridement of the articulating joints.10,11 Metatarsal and proximal phalangeal osteotomy is a joint preserving procedure requiring presence of viable hyaline cartilage on the more anteriorplantar aspects of the first metatarsal head, as this portion of the articular surface migrates towards the dorsal aspect of the joint margin.12,13 Among arthroplasty procedures, Keller’s resection arthroplasty can be complicated by stress fractures of the lesser metatarsals, cock-up deformities and transfer metatarsalgia.14 Numerous variations of this procedure exist, including capsular interposition arthroplasty,15 tendon interposition arthroplasty16,17 and Valenti arthroplasty.18 Capsular interposition arthroplasty aims to correct the deformity, reduce pain, improve function and prevent transfer metatarsalgia while avoiding first MTP arthrodesis. Tendon arthroplasty, in addition, avoids shortening of the metatarsal,18 and therefore push-off strength is maintained. Valenti arthroplasty is a sagittal dorsally based closing wedge osteotomy of the first metatarsal and of the proximal phanlanx. It is used as an alternative to joint destructive procedures when a patient refuses or is not suitable for long-term immobilization and nonweight bearing.18 Implant arthroplasty aims to replace the first MTPJ whilst maintaining stability and function19. Arthrodesis fuses the first MTPJ, provides pain relief but does not restore a normal pressure pattern,20,21 denying the theoretical and clinical principles of energy efficient gait.22 Different classifications are used to assess osteoarthrosis of the first MTP joint, making it difficult to compare the various studies from different centres. Hattrup and Johnson’s classification and Coughlin and Shurnes’s classification are the most used scales. Hattrup and

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Johnson23 classified the radiographic status of hallux rigidus according to three grades: Grade I is characterized by mild-to-moderate formation of osteophytes with no joint space involvement; Grade II, by moderate formation of osteophytes, joint space narrowing and subchondral sclerosis; and Grade III, by marked formation of osteophytes and loss of the joint space with or without subchondral cysts. The Coughlin and Shurnes classification is a reliable five-level clinical-radiographic grading system that incorporates the features of classification system introduced by Hattrup and Johnson.23 Grade 0 is characterized by normal radiographic findings, mild-to-moderate stiffness and loss motion, with no pain; Grades 3 and 4 connote comparable advanced arthritic changes but different clinical findings (nearly constant pain, not at mid-ROM in Grade 3; pain throughout the range of movement in Grade 4).4 Among different scores used to assess satisfactory outcome, the AOFAS hallux MTP score24 is the most commonly administered. This is a 100-point score, composed of separate sections for pain (40 points), function (45 points) and alignment (15 points). Concerning the pain section, 40 points are given for no pain; 30 points for mild, occasional pain; 20 points for moderate, daily pain and 0 points for severe, constant pain. The function section allows for activity, shoe wear, motion and stability. Finally, in the alignment section, 15 points are given for a well-aligned hallux; 8 points for fair alignment, some deformity, but no symptoms and 0 points for symptomatic malalignment. The Foot Function Index (FFI) is a 23 items validated selfadministered scoring system with three subscales involving pain, disability and activity limitation.25 The score was firstly introduced to evaluate foot functions in rheumatoid arthritis patients. We present a comprehensive quantitative review of the published literature on the surgical management of hallux rigidus. The Coleman Methodology Score (CSM)26 was used to assess the methodological quality of the articles included in this systematic review (Fig. 1, Table 1).

Materials and methods Study selection

A comprehensive search of CINAHL, Embase, Medline and the Cochrane Central Registry of Controlled Trials, from inception of the database to 31 October 2010, was conducted to identify articles reporting outcomes of patients who had undergone surgical management of hallux rigidus. The keywords used were ‘hallux rigidus’, British Medical Bulletin 2011

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Fig. 1 Flow chart of studies identified for the systematic review.

‘surgical treatment of hallux rigidus’, ‘osteoarthritis of hallux’, ‘operative hallux treatment’ and ‘hallux’. Subheadings used were ‘surgery’, ‘outcomes’, ‘pathology’, ‘physiology’ and ‘operation’. All journals were considered, and all relevant articles retrieved. Taking in count the authors’ linguistic capabilities, the search included articles in English, Spanish, French, Portuguese and Italian. Case reports, literature reviews, letters to editors and articles not reporting clinical outcomes were excluded from the study. In this review, data were extracted regarding surgical technique, reported outcomes, complications and methodological design. Additionally, every adopted outcome measure assessed three basic fields, namely pain, hallux function and patient satisfaction. As outcome data resulted to be classified as ‘excellent’, ‘good’, ‘fair’ and ‘poor’ in most included studies, success was defined as the percentage of ‘excellent’ and ‘good’ outcomes, and failure rate was calculated as the percentage of ‘fair’ and/or ‘poor’ outcomes.

Quality assessment

We scored each scientific article using the CMS26 system, an accurate and reproducible 10 criteria method assessing the study methodological quality, ranging from 0 to 100. The score 100 would represent a perfect well-designed study with no influence of bias, chance or confounding factors (Table 1). Two investigators (RP and AP) scored each article independently and then discussed any score which differed, until a consensus score was reached. Page 4 of 24

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Table 1 Criteria used to compute the CMS. Section

Number or factor

Score

Part A: only one score to be given for each of the seven sections 1. Study size: number of subjects (n) (if multiple follow-up, multiply n by number of times subjects followed up)

.60

10

41 –60 20 –40 ,20, non-stated .24 12 –24 ,12, not stated, or unclear One surgical procedure only. More than one surgical procedure, but .90% of subjects undergoing the one procedure

7 4 0 5 2 0 10

2. Mean follow-up (months)

3. Number of different surgical procedures included in each reported outcome. More than one surgical technique may be assessed but separate outcomes should be reported

4. Type of study

5. Diagnostic certainty (use of preoperative ultrasound, MRI, or postoperative histopathology to confirm diagnosis)

Not stated, unclear, or ,90% of subjects undergoing the one procedure Randomized control trial Prospective cohort study Retrospective cohort study In all

3 0 5 3 0 10 5 0 2

2 3 3 5 4 3 3 5 5 5

Operative management of hallux rigidus

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In .80% In ,80%, no, not stated, or unclear 6. Description of surgical procedure given Adequate (technique stated and necessary details of that type of procedure given) Fair (technique only stated without elaboration) Inadequate, not stated, or unclear 7. Description of postoperative rehabilitation Well described with .80% of patients complying Well described with 60 –80% of patients Complying Part B: scores may be given for each option in each of the three sections if applicable 1. Outcome criteria (if outcome criteria is vague and does not Outcome measures clearly defined specify subjects’ sporting capacity, score is automatically 0 for this section) Timing of outcome assessment clearly stated (e.g. at best outcome after surgery or at follow-up) Use of outcome criteria that has reported good reliability Use of outcome with good sensitivity 2. Procedure for assessing outcomes Subjects recruited (results not taken from surgeons’ files) Investigator independent of surgeon Written assessment Completion of assessment by subjects themselves with minimal investigator assistance 3. Description of subject selection process Selection criteria reported and unbiased Recruitment rate reported .80% or ,80% Eligible subjects not included in the study satisfactorily accounted for or 100% recruitment

7 0 15 10 0 5

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Statistical methods

Regression analysis was used to assess the extent of agreement between the Coleman scores26 of the two independent assessors and the intraclass correlation coefficient score was calculated.

Results A total of 70 studies (10 prospective,12,20,27 – 34 58 retrospective,1,5,10,11,15,16,18,21,22,35 – 83 1 prospective/retrospective study84 and 1 randomized trial85) published from 1957 to 2010 reported postoperative outcome related data of patients undergoing surgery for management of hallux rigidus.

Clinical and radiographic assessment

Hallux rigidus was defined according to different radiographic and clinical classification grading systems.10,12,18,20,22,27 – 32,59 – 66,68 – 83,85 Coughlin and Shurnes’s4 classification was used in 24 studies1,27,31,33,34,37,39,40,42,44 – 46,49,61 – 64,67,68,73,75,78,83,85 (Table 2), The Hattrup and Johnson’s23 classification in 1312,29,30,35,38,43,47,52,53,70,72,76,79 (Table 3), the Drago, Oloff, Jacobs’s classification86 in 6 studies50,51,71,74,81,82 (Table 4), Regnauld’s classification87 in 6 studies10,11,22,36,59,65 (Table 5), Roukis’s classification28 in 2 studies,28,84 American College of Foot and Ankle surgeons classification55 and Hanft’s classification18 were used in 1 study each. Seventeen studies had no reported classification.5,15,16,20,21,32,41,48,54,56 – 58,60,65,68,69,71 Radiographic and ROM evaluations were performed for clinical and radiological assessment in all studies.

Satisfactory outcome

To assess satisfactory outcomes, the AOFAS scale was administered in 38 studies (Tables 2– 5), the University of Maryland questionnaire in 3 studies,56,71,81 Kitaoka score in 2 studies,69,65 the Foot Health Status Questionnaire (FHSQ),75 Koenig score,63 FFI score,68 Modified Hallux Metatarsophalangeal-Interphalangeal Joint Scale84 and the 33 Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ) in 1 study each. Page 6 of 24

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Table 2 Coleman score of different studies. Author 5

Aas et al. Grondal80 Iqbal and Chana53 Ozan et al.45 Taylor et al.46 Maher75 Tauro67 Myerson et al.57 Becher and Kilger.30 Sinha et al.35 Reize et al.41 Thomas and Smith52 Blyth et al.11 Barca16 Lau et al.38 Brewster et al.49 Harisboure et al.79 Rees et al.72 Coughlin and Shurnas4 Lombardi et al.22 Carpenter et al.47 Dickerson et al.50 Kurtz et al.51 Cosentino54 Hamilton et al.15 Mackay et al.10 Van Diijk et al.66 Waizy et al.65 Malerba et al 62 Can Akgun et al.37 Coughlin and Shurnas39 Olms and Dietze42 Selner et al.55 Mackey et al.58 Townley60 Oloff Lawrence74 Ronconi et al.71 Giannini et al.1 Ettl et al.44 Lin and Murphy48 Southgate and Urry21 Raikin et al.73 Ess et al.32 Harrison et al.33 Derner et al.82 Gonzalez et al 81 Roukis and Townly28 Schenk et al.29 Hahn et al.61 Beertema et al.36 Berlet et al.40 Morandi et al.56

Year

Coleman

(2008) (2005) (1998) (2010) (2004) (2008) (2000) (2000) (2005) (2010) (2007) (1999) (1998) (1997) (2001) (2010) (2009) (2006) (2003) (2001) (2010) (2002) (1999) (1995) (1997) (1997) (1998) (2009) (2008) (2008) (2003) (1999) (1997) (2010) (1994) (2008) (2000) (2004) (2003) (2009) (1997) (2007) (2002) (2010) (2005) (2004) (2003) (2009) (2009) (2006) (2008) (2009)

38 39 42 46 46 47 47 47 48 49 49 49 49 49 50 50 51 52 53 53 53 53 53 53 53 54 54 54 54 54 54 54 54 54 55 56 56 56 56 56 56 58 58 58 59 59 59 59 59 59 59 59

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Table 2 Continued. Author 27

Arbuthnot et al. Hyer et al.77 Saxena18 Taranow et al.68 Hasselman78 Sorbie and Saunders59 Kennedy et al.76 DeFrino et al.20 Mesa-Ramos et al.34 Wassink and Van den Oever64 Konkel et al.63 Daniilidis et al.31 Seeber69 Roukis et al.84 San Giovanni et al.70 Gibson and Thomson85 Easley et al.43 Kilmartin12

Year

Coleman

(2008) (2008) (1995) (2005) (2008) (2008) (2004) (2002) (2008) (2009) (2008) (2010) (2007) (2003) (2007) (2005) (1999) (2005)

60 60 61 61 62 62 63 63 63 64 64 64 66 66 69 74 74 80

Age and follow up

A total of 2739 patients (2905 ft) underwent surgery at an average age of 49.8 years (from 2753 to 6172). The average length of follow-up was 41.1 months (ranged from 780 to 252 weeks58,83).

Type of procedure and postoperative rehabilitation

In 59 studies, 1 single operative technique was performed, while 2 surgical procedures were compared in 11 studies.1,12,21,29,36,58,65,73,77,83,85 The surgical technique was adequately described in 40 studies, fairly in 27 and inadequately in 3. The postoperative rehabilitation programme was described for almost all patients (.80%) in 10 studies, for 60 –80% of patients in 32 studies. There was no description or it was defined for ,60 –80% of patients in 28 studies.

Subject selection, outcome criteria and outcome assessment

The ‘outcome assessment’ section scored fairly in 52 of 70 articles, and poorly in the remaining 18 of 70 articles. Comparing pre- and postoperative status of 838 patients (925 ft) reviewed accordingly to the Coughlin and Shurnes’s classification. The mean reported AOFAS scores improved from 47 (3673 – 6083) preoperatively to 74 (5064 – Page 8 of 24

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Table 3 Studies that have used Coughlin’s classification. Grade

Treatment

Satisfactory outcome

ROM

Arbuthnot et al.27

I, II, III, IV

Hemiarthrosplasty

Berlet et al.40

III

3 Months: 48.60 + 12.288; 12 months 45.50 + 12.728; 24 months 33.30 + 17.198; 36 months 38.60 + 15.018 38.4 + 5.58

Brewster et al.49

III/IV

Interpositional arthroplasty (regenerative tissue matrix) Arthrosplasty (Moje ceramic-on-ceramic)

AOFAS: 3 months 82.20 + 9.5; 12 months 87 + 10; 24 months 84.20 + 10.69; 36 months 95 AOFAS: 87.9

50% of patients 308, 9.38% of patients 758

Can Akgun et al.37

III, IV

Modifield oblique Keller procedure (osteotomy)

AOFAS: 74/100 (range: 9 –100) Satisfaction: 9.38% excellent, 31.25% good, 28.13% fair, 31.25% poor AOFAS: 93.6

Coughlin and Shurnas39 Coughlin and Shurnas4 Daniilidis et al.31

IV

Soft-tissue arthroplasty

I, II, III, IV III

I–III; cheilectomy III (,50% of cartilage) and IV arthrodesis Arthrosplasty

Ettl et al.44

III

Arthrodesis

Giannini et al.1

0, I, III

Gibson and Thomson85 Hahn et al 61 Harrison et al.33 Hasselman78 Konkel et al.63

I, II, III, IV IV IV II, III III, IV

Cheilectomy vs. I, osteotomy vs. III, arthrodesis or arthroplasty (DL-lattic acid) Arthrodesis vs. total replacement arthroplasty Arthrosplasty Cheilectomy Hemiarthrosplasty Hemiarthrosplasty

Maher75 Malerba et al 62 Mesa-Ramos et al.34

III, IV III I, II, III

Arthrodesis Osteotomy Percutaneus cheilectomy þ osteotomy

Olms and Dietze42 Ozan et al.45

III, IV III, IV

Arthroplasty Interposition arthroplasty

Satisfaction: 100% good-excellent results AOFAS: 86; satisfaction: 100% good-excellent results AOFAS: I 95.7; II 92.9; III 89.8; IV 88.9 AOFAS: 82.5 + 14.5 Satisfaction: 91.3% excellent/good AOFAS: 53 (5 –84) VAS: 27/100 AOFAS: 81+ RX: arthrodesis 100% (24 months), arthroplasty 50% no lucency (24 months) AOFAS: 77.8/100 MOXFQ: 9.6/64 (95% CI 14 6.0 –13.2) AOFAS: 82.1 AOFAS score: Tot 83 (62 –100); Grade III: 84 (62 –100); Grade IV Grade III: 92% satisfied; 85% at 8 years FHSQ: 20.95 AOFAS: 82 (80 –100) 78% good-excellent AOFAS: 92.36: grade I: 100; grade II 93; grade III: 90 VAS: grade I: 1.00; grade II: 1.80; grade III: 1.60 Questionnaire: 81% no pain AOFAS: 85.3 + 8.7 Satisfaction: very good 47.4%, good 36.8%, moderate 5.3%, poor 10.5%

51.98

348 Cheilectomy 63.78 (15 –110), arthrodesis 08 52.7 + 15.78

75 + 88 Arthrodesis 26 + 128; arthroplasty. 28 + 148 Dorsiflex 48.1 –56.88; plantarf. 28.1 –33.38 658 648 (30 –100)

Dorsiflex 448 (15 –558)

TOT: 508 (range: 40 –608) TOT: 32.4 + 4.48

Continued

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Author

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Page 10 of 24 Table 3 Continued. Author

Grade

Treatment

Satisfactory outcome

ROM

Raikin et al.

III, IV

Hemiarthrosplasty vs. arthrodesis

Taranow et al.68

II, III

Hemiarthrosplasty

Tauro67

I, II, III, IV

Arthrodesis

88 (4 –128)

Taylor et al.46

No reported

Arthrodesis (two screw)

Wassink and Van den Oever64

No reported

Arthrodesis

Hemiarthrosplasty: 24% excellent, 33% good, 10% fair, 33% poor Arthrodesis: 78% excellent, 4% good, 15% fair, 4% poor. (P ¼ 0.006) Satisfaction: 23 patients satisfied, 3 patients satisfied with reserves, 2 patients dissatisfied Satisfaction: 72%; satisfactory with reserves 28%, NO satisfactory Questionnaire: 64.7% excellent, 23.5% good, 11.8% poor 82.4% procedure done again AOFAS-HMI: 56: 50/60 (men), 10/60 (women) 96.3% complete union

73

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Table 4 Studies that have used Hattrup/Johnson’s classification. Grade

Treatment

Satisfactory outcome

ROM

Becher and Kilger30

II, III

Cheilectomy

AOFAS: Grade II: 84 (65 –100)

Grade II: 518 (20 – 758)

II, III

Arthroplasty

Grade III: 71 (35 – 87) AOFAS: 89.31 (range: 70 –100) (P , 0.001)

Grade III: 338 (5 –558)

Carpenter et al.47 Easley et al.43

I, II, III

Cheilectomy

AOFAS: 85 (Grade I: 89 + 12, Grade II: 84 + 14, Grade III: 84 + 19)

Harisboure et al.79 Iqbal and Chana53 Kennedy et al.76 Kilmartin12

I, II, III

Osteotomy

I/II

Arthroscopic, cheilectomy

AOFAS: Grade I: 83.4/100 (75 –100), Grade II: 81.5/100 (53 – 100), Grade III: 86.4/100 (67 –100). No pain: 94% Satisfaction: 60% very satisfied, 40% satisfied. Not satisfied

648 (Grade I: 76 + 178, Grade II: 62 + 178, Grade III: 52 + 128) Grade I: 578 (45 –908); Grade II: 51.88 (50 –808) Grade III: 25.68 (0 –558) 69.38 (range: 60 –808)

I, II

Arthroplasty

AOFAS: 78.4 /100 punti, SF 36: 96.3 points

648 (range: 25 –708)

II

AOFAS: phalanx osteotomy 88 + 10, MT osteotomy 88 + 6.8

Lau et al.38

II, III

Rees et al.72

I, II, III

Phalanx osteotomy vs. MT osteotomy Cheilectomy vs. interpositional arthroplasty Osteotomy

Phalanx osteotomy 35 + 88 (dorsiflex), MT osteotomy 42 + 98 (dorsiflex) 30.2 + 7.98 cheilectomy, 30.9 + 88 interpositional arthroplasty 418 (5 –808) (dorsiflex)

San Giovanni et al.70 Schenk et al.29

II

Hemiarthrosplasty

I, II

Interposition arthroplasty vs. resection arthroplasty

Sinha et al.35 Thomas and Smith52

III No reported

Arthroplasty Proximal phalanx osteotomy

AOFAS: cheilectomy 77.3, interposition arthroplasty 71.6. Satisfaction: cheilectomy 87.5 %, interpositional arthroplasty 72.7% AOFAS: Grade I: 50 % Grade II: 70% Grade III: 78% satisfied Rx foot: good 85% AOFAS: 80.4/100. 67% need second surgery procedure; final 538 (dorsiflex) outcome: 94% excellent/good; 5% good; 1% poor AOFAS: interposition arthroplasty: 89/100; resection arthroplasty: 88/ Interposition arthroplasty: 66.58, 100 resection arthroplasty: 52.28 Outcome: interposition arthr: 63% excellent, 14% good, 18% poor, 5% fair; resection Arthr: 63% excellent, 10% good, 17% poor, 10% fair AOFAS: 62 (range: 10– 82); satisfaction: 58 % good-excellent PAIN: 58% no pain and 42% mild pain. 100% union rate of the osteotomy

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Page 12 of 24 Table 5 Studies that have used Regnauld’s classification. Author

Grade Treatment

Satisfactory outcome

ROM

Beertema et al.36

I, II, III

Cheilectomy vs. arthroplasty vs. arthrodesis

Blyth et al.11

I, II

Osteotomy

Cheilectomy: Grade I 61 + 9.18, Grade II 46 + 23.98; arthroplasty: Grade I 70 + 8.28, Grade II 57 + 18.58, Grade III 65 + 11.28; arthrodesis 08: 478

Lombardi et al.22

III

Arthrodesis 1 MTF with screw

Mackay et al.10

I, II, III

Cheilectomy

AOFAS: Cheilectomy: Grade I 87, Grade II 82 arthroplasty: Grade I 94, Grade II 83, Grade III 87; arthrodesis: Grade I 81, Grade II 73 Pain: 44.5%. (P ¼ 0.00014) Patient activity level: 72.3% unlimited; 27.7% limitation AOFAS: 75.6 Rx foot: IM angle 8.58; an angle of declination MT 17.38; talo-metatarsal angle 58; angle of abduction of the big 118 (P ¼ 0.001) Pain: Grade I: 61% no pain, 33% pain in sport, 6% walking; Grade II: 60% no pain, 40% pain in sport; Grade III: 33% no pain, 33% pain in sport, 17 % walking, 17% constant Satisfaction: 100% Grade I, 66% Grade II, no Grade III AOFAS: 88.2 + 18.7 Cheilectomy: 21.7% (2 follow-up), total satisfaction, 23.9% (2 follow-up) satisfaction, 4.4% (2 follow-up), dissatisfied; cheilectomy þ osteotomy: 32.6%, total satisfaction, 15.2% satisfaction, 15% 2.2% (2 follow-up), dissatisfied

Cheilectomy Grade I 43.68, Grade II 38.278, Grade III; cheilectomy þ osteotomy: Grade I 408, Grade II 368, Grade III 32.58

Sorbie and III Saunders59 Waizy et al.65 III, IV

Hemiartroplasty Cheilectomy vs. cheilectomy þ osteotomy (Kessel-Bonney)

Dorsiflex 58.92 + 11.398; Plantaflex 4.24 + 6.928

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10064,67,83) postoperatively after arthrodesis, from 43 (range from 29.137 to 5834) to 88.5 (from 811 to 10037) in patients who had underwent osteotomy technique, from 48 (2483 –7083) to 85.3 (6783 –10083) in patients who had undergone cheilectomy and from 35 (2627 –4627) to 85 (7173 – 10027,73,78) following hemiarthroplasty, from 55 (4639 – 63.940) to 86.4 (8545 –10040) in those who had received arthroplasty (Table 2). Regarding 576 patients (671 ft) who were assessed according to the Hattrup/Johnson’s classification, the AOFAS scores improved from an average preoperative value of 48 (range from 3012 to 7279) to an average postoperative score of 89 (from 7812 to 10012,72,79) after osteotomy, from a mean of 46 (1830 –7530) to 77 (3530 –10030) after cheilectomy, from 53 (4970 –5729) to 82 (6235 –10070) after arthroplasty. (Table 3) and from 58.45 to 92.36 after combined cheilectomy and osteotomy.34

The average preoperative and postoperative AOFAS scores in patients treated by different procedures and evaluated according to different grading systems are reported in Table 6

The mean preoperative Kitaoka score of 25.5 points improved to an average of 8169 points postoperatively. Concerning the University of Maryland questionnaire,56,71,81 preoperative data were not reported, but postoperative scores ranged from 75 to 100.81 The FFI score was 76.1 for pain (range: 28.4 –100), 73.4 for discomfort (range: 11.1– 98.8), 29.3 (range: 11.1– 95.6) for activity, 18.8 (range: 1.6– 77.8) for postoperative pain, 18.4 (range: 0– 79) for discomfort and 8.1 (range: 0– 42.2)68 for activity. The average FHSQ score improved from 41.65 preoperatively to 20.95 postoperatively,75 while the Modified Hallux Metatarsophalangeal-Interphalangeal improved from 25.0 + 15 to 85.8 + 12.0 postoperatively84 (P , 0.001). The MOXFQ changed from 33/64 preoperatively to 9.6/64 postoperatively.33 Reported mean postoperative Koenig scores rated 85 (range: 64 – 96)63 in Grade III patients were assessed by using the Hattrup/Johnson’s classification.

Range of movement

Range of movement (ROM) data were extracted from 29 of 70 studies. The preoperative ROM of 2781 improved postoperatively to 6443 in 542 patients receiving a cheilectomy.1,10,30,33,34,36,43,48,53,55,56,65,83 Comparing pre- and postoperative ROM measures in 530 patients who had undergone an osteotomy, the preoperative mean of 20.18 (range: 6.537 –33.582)28,1,11,12,18,21,29,34,55,62,71,79,82 improved to postoperative mean of 39.38 (range: 23.518 –72.182).1,11,18,21,28,29,34,36,50,51,55,62,71,79,82 British Medical Bulletin 2011

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Page 14 of 24 Table 6 Studies that have used DRAGO, OLOFF, Jacobs’s classification. Author Derner et al.

82

Dickerson et al.50

Gonzalez et al.81 Kurtz et al.51

Grade

Treatment

Satisfactory outcome

ROM

II, III

Osteotomy plantar displacement Green-Watermann Osteotomy

AOFAS: 78.1/100 85% excellent/good, 8% good, 4% poor, 4% fair Pain: 30/32 (94%) significantly relieved.

TROM: 72.18 (range: 50 – 1008)

No reported

Dorsiflex 588 (range: 44 –858); plantarflex98 (range: 5 – 208)

II, III

Hohman osteotomy

I, II, III

Valenti osteotomy

Satisfaction: excellent (90 –100) 50%; good (70 –89) 37.5%; fair (60 –69) 0%; poor (,60) 22.5% Questionary ‘The University of Maryland’: 96% excellent (90 –100), 4% good (75 –89) AOFAS: 84 (range: 45 –100) Questionnaire: 81.8% improved pain, 66% continued pain, 33.3% no pain, 45.5% occasional pain AOFAS: 55 (14 –70)

58 (0 –108)

Final satisfaction: 85.71 % pcs Questionnaire: 84% excellent-good, 7% poor, 9% fair

Dorsiflex: 458, plantarlfex: 188

Oloff Lawrence74

III, IV

Osteotomy 1 MT

Ronconi et al.71

I, II

Osteotomy 1 MT (triplane)

Dorsiflex 58.92 + 11.398; plantaflex 4.24 + 6.928 57.88 (range: 33 –1008), dorsiflex: 44.88 (range: 25 – 808), plantarflex 13.08 (range: 5 –228)

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Operative management of hallux rigidus

With regard to 572 patients undergoing arthroplasty, ROM increased from a preoperative average of 24.88 (range: 4.927 – 47.229)1,15,16,27 – 29,31,32,39,40,42,45,57,58,61,63,69,70,76,78,84,85 to a postoperative average of 458 (range: 16.827 – ROM 66.529).1,15,16,27 – 29,31,32,36,39,40,42,45,54,58,61,63,69,70,76,78,84,85 decreased postoperatively to an average 01,21,36,58,83,85 in 289 patients undergoing an arthrodesis (Tables 2–5). The average preoperative and postoperative ROM in patients treated by different procedures are reported in Table 7.

CMSs and statistical results

The means of the CMSs for each section are listed in Table 8: the average CMS score was 56.7 (range: 385 –8012). Reported outcomes and complications, different methods of reporting results, have been used in almost all the articles. A 74% success rate (ranged from 4053 to 100%10) has been reported after cheilectomy, 69% (ranged from 46%65 to 82%62) after osteotomy, 73.2% (ranged from 64.7%46 to 78%73) after arthrodesis, 70.2% (ranged from 24%73 to 93%31,60) after arthroplasty and 73.4% (from 47.4%45 to 100%39) after interpositional arthroplasty.

Complications and associated findings

Among 530 patients undergoing an osteotomy, 7 (1.3%) developed an infection: a localized infection which resolved spontaneously was reported in 1 patient,72 after positioning of bioreabsorbable poly (DL-lattic acid) implant,1 while a re-operation was performed in 4 patients. Metatarsalgia was diagnosed in 16 of 530 patients (3%),11,29,37,55,82 sesamoiditis55 in 1 (0.2%), toe hypoesthesia in 5 (0.9%),11,29,34 floating hallux in 4 (0.8%),29 persistent pain in 3 (0.6%),29 and algodistrophy in 1 (0.2%).29 Orthotics were needed in 2 of 530 patients (0.4%),55 pin breakage56 was observed in 3 cases (0.6%) and a stress fracture in 1 (0.2%).37 Among 572 patients who had undergone arthroplasty, 2 (0.3%) had infection and 3 (0.5%) superficial infection41,68,78 Additionally, metatarsalgia was reported in 5 patients (0.9%),42 sesamoid pain in 4 (0.7%),42 periarticular ossification in 3 (0.5%),42 hallux valgus and oedema in 1 (0.2%) patient each.41 Six patients (1%) had Morton’s neuroma.27,29 Among 91 patients who had undergone interposition arthroplasty, metatarsalgia39,45 and loss of ground contact of the hallux45 were British Medical Bulletin 2011

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Page 16 of 24 Table 7 Pre–postoperative AOFAS score and classifications grading systems. AOFAS

Arthrodesis Osteotomy Cheilectomy Hemiarthroplasty Arthroplasty

Coughlin and Shurnes’s 838 patients (925 ft)

Hattrup/Johnson’s 576 patients (671 ft)

Drago, Oloff, Jacobs’s 163 patients (184 ft)

Regnaul d’s 140 patients (144 ft)

Roukis’s 44 patients (47 ft)

Preoperative

Postoperative

Preoperative

Postoperative

Preoperative

Postoperative

Preoperative

Postoperative

Preoperative

Postoperative

47 43 48 35 55

74 (50 –100) 88.5 (81 – 100) 85.3 (67 – 100) 85 (71 –100) 86.4 (85 – 100)

– 48 (30 –72) 46 (18 –75) – 53 (49 –57)

– 89 (78 –100) 77 (35 –100) – 82 (62 –100)

– 25.8 – – –

– 78 (52 – 100) – – –

39.1 – – – –

84 (75.6 –100) – – – –

– 54.4 – 51.1 –

– 84.6 – 77.8 –

(36 –60) (29.1 – 58) (24 –70) (26 –46) (46 – 63.9)

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Table 8 Pre-post operative ROM and classifications grading systems. ROM Arthrodesis, 289 patients

Osteotomy, 530 patients

Cheilectomy, 542 patients

Hemiarthroplasty

Arthroplasty, 572 patients

Preoperative 178

Preoperative 20.18 (6.5 –33.58)

Preoperative 278

Preoperative –

Preoperative 24.88 (4.9 –47.28)

Postoperative 08

Postoperative 39.38 (23.5 –72.18).

Postoperative 648

Postoperative –

Postoperative 458 (16.8 –66.58)

Operative management of hallux rigidus

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found in 15 patients each (16.5%), hypoesthesia of the hallux in 3 (3.3%), haematoma, hallux valgus and continuous pain each present in 1 patient (1.1%).54 Regarding 289 patients who received arthrodesis, screws and hardware were, respectively, removed in 8 (2.8%) and 2 (0.7%) cases for intolerance or pain,22,46,57 a non-union developed in 16 ft (5.6%),5,22,46 and a delayed union in 3 patients (1%).46 Seven of 289 (2.4%) patients received antibiotics for management of cellulitis,83 2 (0.7%) had infection46,80 and 7 (2.4%) a superficial infection, including a myocardial infection.46,57 Bone was destroyed in 5 patients (1.7%),36 9 patients (3.1%) had poor quality of missing36 and 4 (1.4%) had metatarsalgia.46 After cheilectomy, 7 of 542 patients (1.3%) underwent antibiotic therapy for management of cellulitis while superficial infection was observed in 2 patients (0.4%).43,48,83 Postoperative paresthesiae were evident in 6 of 542 patients (1.1%).34,43 Eleven of 542 patients (2%) required further intervention for procedure failure,33,83 and 2 (0.4%) underwent arthrodesis for postoperative stiffness.83 Chondrolysis was detected on radiographic assessment in 2 patients (0.4%).83

Discussion The first MTPJ acts as a fulcrum able to sustain high pressures and loading forces during the bipedal motion.88,89 When local structures become insufficient, compensatory mechanisms need to be utilized. As aetiology, symptoms, duration of symptoms, biomechanics, systemic conditions, type of pain, personal/social level have to be considered, there is currently no agreement on the management of this complex but common condition.12,18,90 The present review reports on outcomes of patients undergoing surgery for management of hallux rigidus. Most findings have been presented in reasonable fashion, either reporting on biomechanical effects or postoperative symptoms, resulting in marked benefits for the quality of life of the operated patients. If surgical success rates are not conclusive, morbidity, complication, failure rates and early return to work activity were considered. According to the published literature, there are no standard procedures to manage different grades of hallux rigidus. As no consensus has been reached on clinical classification grading systems, it is difficult to compare postoperative outcomes. The results could be influenced by the experience of surgeons and variability in patients’ selection process. The heterogeneity in terms of study design, length of follow-up, classification grading systems, Page 18 of 24

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radiological and clinical findings did not allow to compare extracted data. The large variety of scales assessing the clinical status limited the statistical power of the study. Additionally, non-validated scoring systems assessing satisfactory outcomes were used in many reports.64,71,72 Concerning the methodological assessment, we used the CMS, a validated reliable scoring system.26 The heterogeneity of included studies precluded the intention to perform a meta-analysis. Despite these limitations, according to reported data, an average 74% (range from 40%53 to 100%10) success rate has been reported after cheilectomy, a mean of 69% (range from 46%65 to 82%62) after osteotomy, 73.2% (range from 64.7%46 to 78%73) after arthrodesis, 70.2% (range from 24%73 to 93%31,60) in patients who underwent arthroplasty, and 73.4% (from 47.4%45 to 100%39) after interpositional arthroplasty. The surgical criteria are based on the deformity grading, classified according to different scales categorizing the hallux rigidus.4,18,23,72,87 The indications for surgical management of hallux rigidus are unclear. However, regardless of classifications, if cheilectomy and first metatarsal or phalangeal corrective osteotomy should be performed in early staged hallux rigidus (Stages I– II), arthrodesis or arthroplasty are indicated to manage Stages III –IV.91 Although several complications have been observed, mostly after osteotomy, significantly improved ROM has been reported in patients undergoing osteotomy for management of intermediate staged hallux rigidus, regardless of classifications.12,18,62,71,72,74,79,81,82 Cheilectomy has been used for each grade of hallux rigidus in several studies,10,30,33,38,43,65,79 but the best results have been obtained in Grade I or early Grade II hallux rigidus, where the pathology involved only the dorsal aspect of the first MTP joint.4,10,30 Loss of motion and progression of first metatarsal –sesamoid joint disease have been reported in a high percentage of Grade II and III patients followed for 2 years or longer.30,43,79 Kilmartin12 reported whether the shortening of the 1st MT or proximal phalanx targets primarily to restore MT alignment, increasing the base of the hallux. Several studies62,71,72,79,81 reported decreased pain and improved ROM performing an additional osteotomy after cheilectomy for patients with conserved mid-ROM.65 However, patients with severe arthritic changes and pain throughout the ROM have poorer outcomes with these procedures, and are better served by procedures such as excisional arthroplasty, interposition arthroplasty and implant arthroplasty and arthrodesis.

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The Valenti arthroplasty allows recovery of dorsal-flexion in cases of moderate hallux rigidus.18,51 Although Keller’s arthroplasty of the first MTP joint provides good AOFAS outcomes and short postoperative recovery time,37 hallux shortening and the loss of motion may be unacceptable complications.29,37 Excisional arthroplasty techniques are best indicated for low demand patients92 with lower grades of hallux rigidus, as they involve short surgical and recovery time.29 Satisfactory AOFAS score and improved ROM have been observed in higher graded hallux rigidus (III – IV according to Coughlin and Shurnes and II– III according to Hattrup and Johnson) after interposition arthroplasty, but longer follow-up studies should be conducted to assess the long-term complications29,40,45. Good-excellent AOFAS score and high improvement of ROM were observed after positioning of a prosthetic joint replacement for management of both early stage47,76 and late stage1,31,35,42,49,61 of hallux rigidus. Regardless of grading, high rate of satisfactory outcomes associated with ROM preservation have been obtained after implantation of hemiarthroplasty.27,59,63,68,70,73,78 Since there is a lack of long-term follow-up studies, up to date hemiarthroplasty can be considered an alternative to fusion only in patients who wish to maintain a functional ROM for severe hallux rigidus. Arthrodesis eliminated the joint painful motion improving the clinical scores in patients with diffuse osteoarthrosis of the first MTP.4,19,22,64,67,75,77,80 On the basis of available findings, arthrodesis of the first MTP joint is best indicated for active patients, when joint preserving procedures are contraindicated, for revision of failed excision arthroplasty and implant arthropalsty.22,36,64 The effects of arthrodesis vs. joint preserving arthroplasty for the advanced stage of hallux rigidus in older and physically lower demand patients are still debated. Should motion of the joint be sacrificed for stability of the hallux, and for consistent, predictable and reliable outcome of the procedure? There are no validated functional studies comparing the limitation of function and activities after arthrodesis and arthroplasty. Additionally, controlled prospective studies of patients undergoing arthrodesis and the newer versions of modified arthroplasty are needed. No study reported on the return to preoperative activity, and there is lack of information on the role of rehabilitation exercises to improve the clinical and functional status. As surgery alone is not enough to return to full activity, physiotherapy and duration of postoperative immobilization should be taken into account. Finally, the role the postoperative footwear or anti-inflammatory drugs should be clarified. In conclusion, evidence-based guidelines are needed to establish the Page 20 of 24

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use of standard surgical procedures for the management of hallux rigidus.

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