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The effectiveness of surgery for adults with hallux valgus deformity: a systematic review protocol 1

Jitka Klugarova, PhD 2

Victoria Hood, PhD

2

Fiona Bath-Hextall

Miloslav Klugar, PhD Jana Mareckova

1

1 1

Zuzana Kelnarova, PhD

1. The Czech Republic (Middle European) Centre for Evidence-Based Health Care: An affiliated centre of The Joanna Briggs Institute 2. The University of Nottingham Centre of Evidence Based Health Care: A Collaborating Centre of the Joanna Briggs Institute

Corresponding author: Miloslav Klugar, [email protected]

Objective To establish the effectiveness of surgery compared to conservatory management for adults with hallux valgus.

Background Hallux valgus (HV) is a complex progressive triplanar forefoot deformity, characterized by a valgus deviation of the big toe, a metatarsus primus varus and a medial prominence on its head. It develops gradually due to interaction of biomechanical factors, structural anomalies, systemic diseases, 1

hereditary predispositions and wearing of inappropriate footwear.

Hallux valgus is common foot deformity. One published systematic review with meta-analysis on this topic reported the wide variation in prevalence of HV in analyzed primary studies and confirmed higher prevalence of HV in woman and older adults. They found that HV deformity affects on average 23% of 2

adults aged 18-65 years and 35.7% of older adults aged over 65 years.

The patients usually complain about pain, difficulties during walking and problems with footwear. Nix et 3

al. found in a systematic review that there are biomechanical changes in the gait of patients with HV. These included reduced peak of dorsiflexion and rear foot supination during terminal stance. In older

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patients with HV they described a less stable gait pattern with reduced velocity and stride length during walking on irregular surface. Over the past 80 years, HV problems have been dealt primarily by surgeons specialized in orthopaedics. In the available literature more than 130 surgical procedures have been described, 4

correcting the axis of the first ray. Although the most effective therapy is generally prevention, in clinical practice many patients with foot disorders visit a healthcare professional at a more advanced stage of their problem. In mild stages of HV, conservative treatment is recommended and this usually involve the use of different type of orthoses, e.g. night splints, or taping. Other options are physical therapy, including manual therapy, mobilization, foot exercise, sensomotoric training, thermotherapy, hydrotherapy and ultrasound therapy. Brantingham et al.

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found that a progressive mobilization of the first

metatarsophalangeal joint had positive effects on pain and Foot Function Index (FFI). Du Plessis et.al.

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tested the effect of a modified structured protocol of manual and manipulative therapy (the Brantingham protocol) on HV related pain (visual analog scale), FFI and range of hallux dorsiflexion (goniometry) and compared to orthotic therapy using a night splint. They did not find any significant differences between 7

these two interventions after three weeks in patients with mild to moderate HV. Bayar et.al. reported that eight-weeks taping of the first ray and forefoot combined with foot exercise decreased hallux valgus angle (goniometry), foot pain (visual analog scale), and improved walking ability (the walking ability 8

scale) by at least one grade in the patients with HV. Radovic and Shah demonstrated that use of botulinum toxin A injection reduced the hallux abducto valgus deformity clinically and radiographically and also its associated pain in a 43-year-old woman presented with a chief complaint of bilateral bunion pain. In severe stages of this condition surgery is often used. The aim of HV surgery is either to correct the 9

bony or soft tissues or both tissues. Surgical procedures for HV include simple bunionectomy, various soft tissue procedures, metatarsal and phalangeal osteotomies, resection arthroplasty and 10

metatarsophalangeal arthrodesis.

Bunionectomy is a simple procedure based on shaving off the

medial prominence on the medial side of the first metatarsophalangeal joint. Arthroplasty is combination of bunionectomy and removal of part of the proximal phalanx; this procedure is indicated in severe stages of HV and leaves a flexible joint, but shorter first ray. Arthrodesis is more radical procedure than arthroplasty and is based on excision of head of first MTPJ and fusion of the operated segment. Osteotomy of the first metatarsus includes proximal and distal procedures. Distal osteotomy, e.g. Chevron osteotomy, is indicated in patients with mild HV and proximal osteotomy, such as scarf osteotomy, in severe stages of HV deformity. Soft technique procedures often complement the bony 9,11,12

procedures.

The effectiveness of HV treatment is verified in clinical practice, in most cases by radiological examination (Hallux valgus angle and 1,2-intermetatarsal angle), visual analog scale (pain), assessment scoring system developed by American Orthopaedic Foot and Ankle Society (pain, 9

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satisfaction, range of movement), FFI, etc. In 1979, Stokes et al. did the first evaluation of the effect of HV surgery using biomechanical analysis of gait. During the last 30 years, many other researchers have used different type of motion analysis software to evaluate the impact of HV surgery on dynamic and 13-17

kinematic parameters of gait.

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Many primary studies have evaluated effect of treatment of HV surgery, however to date there is no systematic review which has studied the effect of HV surgery or conservative management on gait, pain or function.

Keywords hallux valgus, surgery, meta-analysis

Inclusion criteria Types of participants This review will include adults (18 years or older) with hallux valgus deformity, excluding adults with neurological problems causing foot deformities e.g. cerebral palsy, neuropathy, stroke, MS. Types of intervention(s)/phenomena of interest The review will include any type of hallux valgus surgery compared to no surgery, conservative treatment (such as physical therapy, kinesio taping, orthosis, etc.) and comparison among different types of hallux valgus surgeries will also be included. Types of outcomes The primary outcome: - gait measures: assessed by any validated assessment tool (such as biomechanical movement analysis, etc.). The secondary outcomes: - quality of life: assessed by any validated assessment tool (such as SF-36, etc.), - patient satisfaction using any validated assessment tool, - pain using any validated pain assessment tool (such as the Visual Analogue Scale, Verbal Rating Scale, McGill Pain Questionnaire, etc.), - adverse events. All the above outcomes measured at the following time points: short-term: < 6 months after surgery, medium-term: 6-12 months after surgery, long-term: > 1 year after surgery. Types of studies The review will include all randomized controlled trials. However, in the absence of RCTs, non-randomized controlled trials and quasi-experimental studies will be included.

Search strategy The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. This will be followed by the title, abstract and index term of each article being analyzed. An initial limited search of MEDLINE, Embase and CINAHL will use keywords, such as "hallux valgus", "bunion", "surgery".

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A second search using all identified keywords and index terms will then be undertaken in the following databases: Medline (Ovid MEDLINE(R) 1946 to current) Cinahl (CINAHL® Plus with Full Text 1935 to current) Embase (1974 to current) Tripdatabase Nursing ovid Web of Science Cochrane library Pedro The search for unpublished studies will include: grey literature (GoogleScholar, ClinicalTrials.gov, The Grey Literature Report, Current Controlled Trials, Cos Conference Papers Index, Scirus), dissertation theses (ProQuest), etc. Thirdly, the reference list of all identified reports and articles will be searched for additional studies. Studies published in all languages will be considered for inclusion in this review if they contain an abstract written in English. Studies published in any date will be considered for inclusion in this review. Initial keywords to be used will be: 1. hallux valgus OR halux valgus OR hallux abductovalgus OR halux abductovalgus OR bunion* OR great toe deformit* OR big toe deformit* OR foot deformit* OR forefoot deformit* OR foot problem* 2. surg* OR operat* OR osteotom* OR arthrodes* OR arthroplas*

Assessment of methodological quality Papers selected for retrieval will be assessed by two independent reviewers (JK and VH) for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.

Data collection Data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives.

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Data synthesis Quantitative data will, where possible, be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Effect sizes expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square. Where statistical pooling is not possible the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate.

Conflicts of interest All the reviewers have no potential conflicts of interest.

Acknowledgements This systematic review is supported by European grants: Support for the creation of excellent research teams and intersectoral mobility at Palacký University in Olomouc II (CZ.1.07/2.3.00/30.0041).

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References 1. Lorimer DL, Neale D, French GJ. Neale's disorders of the foot. Edinburgh Churchill Livingstone; 2006. 2. Nix SE, Smith M, Vicenzino B. Prevalence of hallux valgus in the general population: a systematic review and meta-analysis. J Foot Ankle Res. 2010; 3(1): 21. 3. Nix SE, Vicenzino BT, Collins NJ, Smith MD. Gait parameters associated with hallux valgus: a systematic review. J Foot Ankle Res. 2013; 6(1): 9. 4. Robinson AH, Limbers JP. Modern concepts in the treatment of hallux valgus. J Bone Joint Surg Br. 2005; 87(8): 1038-45. 5. Brantingham JW, Guiry S, Kretzmann HH, Kite VJ, Globe G. A pilot study of the efficacy of a conservative chiropractic protocol using graded mobilization, manipulation and ice in the treatment of symptomatic hallux abductovalgus bunion. Clinical Chiropractic. 2005; 8(3): 117-133. 6. du Plessis M, Zipfel B, Brantingham JW, Parkin-Smith GF, Birdsey P, Globe G, et al. Manual and manipulative therapy compared to night splint for symptomatic hallux abducto valgus: An exploratory randomised clinical trial. The Foot. 2011; 21(2): 71-78. 7. Bayar B, Erel S, Simsek IE, Sümer E, Bayar K. The effects of taping and foot exercises on patients with hallux valgus: a preliminary study. Turk J Med Sci.2011; 3(41): 403-409. 8. Radovic PA, Shah E. Nonsurgical treatment for hallux abducto valgus with botulinum toxin A. J Am Podiatr Med Assoc. 2008; 98(1): 61-5. 9. Ferrari J, Higgins JP, Prior TD. WITHDRAWN: Interventions for treating hallux valgus (abductovalgus) and bunions. Cochrane Database Syst Rev. 2009; (2): CD000964. 10. Bascarevic Z, Vukasinovic ZS, Bascarevic VD, Stevanovic VB, Spasovski DV, Janicic RR. Hallux valgus. Acta Chir Iugoslavica. 2011; 58(3): 107-11. 11. Dungl P. Ortopedie. Praha: Grada; 2005. 12. Wulker N, Mittag F. The treatment of hallux valgus. Dtsch Arztebl Int. 2012; 109(49): 857-67; quiz 868. 13. Stokes IA, Hutton WC, Stott JR, Lowe LW. Forces under the hallux valgus foot before and after surgery. Clin Orthop Relat Res. 1979; 142: 64-72. 14. Bryant AR, Tinley P, Cole JH. Plantar pressure and radiographic changes to the forefoot after the Austin bunionectomy. J Am Podiatr Med Assoc.2005; 95(4): 357-65. 15. Milani TL, Retzlaff S. Analysis of pressure distribution for the evaluation of gait in patients with hallux valgus surgery. Z Orthop Ihre Grenzgeb. 1995; 133(4): 341-6. 16. Nysk M, Liberson A, McCabe C, Linge K, Klenerman L. Plantar foot pressure distribution in patients with Hallux valgus treated by distal soft tissue procedure and proximal metatarsal osteotomy. J Foot Ankle Surg. 1998; 4(1): 35-41. 17. Saro C, Andrén B, Felländer-Tsaia L, Lindgrena U, Arndta A. Plantar pressure distribution and pain after distal osteotomy for hallux valgus: A prospective study of 22 patients with 12-month follow-up. The

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Foot.2007; 17(2): 84-93. Insert page break

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Appendix I: Appraisal instruments MAStARI appraisal instrument this is a test message

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Appendix II: Data extraction instruments MAStARI data extraction instrument

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