Evidence review: surgery for bunions/hallux valgus. for North West London Collaboration of CCGs

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Mervyn Pearson
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1 Evidence review: surgery for bunions/hallux valgus for North West London Collaboration of CCGs

2 Disclaimer ICHP was invited to conduct a brief review of current evidence and guidelines in the management of bunions/hallux valgus. The evidence is summarised in such a way that it could inform future decisions by the CCG on policy. For the avoidance of doubt, this note is purely advisory and the responsibility for all decisions on policy within North West London (NWL) lies solely with NWL Collaboration of CCGs and individual CCGs. No part of this document should be interpreted as clinical guidance. Background and context Hallux valgus is a common chronic foot problem that in some cases may be severely disabling due to foot pain, gait and balance impairment and increased risk of falls in the older population. It has an estimated prevalence of 23% among adults aged years which increases to 35.7% in the population aged over 65. In the 2016/17 financial year a total of 9400 procedures were performed across the NWL STP for bunions, incurring a total cost of 954,636 at an average of 102 per procedure (figures supplied by NWL Collaboration of CCGs). This is believed to demonstrate an area with a significant potential for efficiency savings and the purpose of this review is to inform the development of a new CCG policy on the surgical management of hallux valgus. Hallux valgus refers a lateral angulation of the great toe, overlying the second toe in very severe cases. The resulting prominence of the first metatarsal head is susceptible to developing inflammation in the overlying soft tissue and bursa, leading to the symptoms described above. Management of hallux valgus is aimed at symptom relief, reducing deformity and prevention of complications such as gait or balance problems and increased risk of falls. Treatment options include: Non-surgical o Analgesia o Modification of footwear o Orthoses: these include splints, bunion shields and toe spacers Surgical: Numerous operative techniques have been described in the treatment of hallux valgus 1 and the choice of procedure largely depends on the degree and type of deformity and individual surgeon s preferences. Discussion of each of these techniques is beyond the scope of this review although specific procedures have been mentioned where relevant. Evidence review Non-operative management Non-operative treatment has always been the recommended first line in the management of hallux valgus. Footwear modification, such as the use of soft leather shoes with extra width and depth of the toe box has been recommended treatment of choice in patients of advanced age and in those with neurological or vascular compromise 2. The evidence around the use of orthoses is conflicting. A small study comparing the use of insoles with toe separators with night splints showed that the former significantly Imperial College Health Partners Page 2

3 improved foot pain after three months, with no significant difference observed in the group using night splints. Neither treatment significantly improved hallux valgus angle or intermetatarsal angle. Custom-made foot orthoses have been shown to improve foot pain at 6 months posttreatment but not at 12, with no difference in the health-related quality of life of patients receiving orthotic treatment and those receiving no treatment 3. However, orthoses do not correct the deformity in hallux valgus and neither have they been shown to slow or prevent its progression 2. A study examining the radiographical changes associated with hallux valgus demonstrated similar progressions in the first intermetatarsal and hallux abductus angles in women treated with custom made foot orthoses and the control group following 12 months of treatment 4. Surgical management Surgery for hallux valgus or bunions is the most common foot operation performed in developed countries. Current indications for pursuing surgical treatment include 1,5 : A painful bunion that is worsening despite conservative treatment Involvement of the second toe (overlapping or underlapping) Severe limitations in lifestyle such as pain or difficulty with footwear and inhibition of activity or lifestyle Secondary foot problems such as neuritis/nerve entrapment, hammer digits, first metatarsocuneiform joint exotosis, sesamoiditis, ulceration, inflammatory conditions of the first metatarsal head (e.g. bursitis or tendinitis) The principal contraindication for surgery is peripheral vascular disease 1. Other contraindications include 5 : Active infection or septic arthritis Active osteoarthropathy Lack of pain or deformity Advanced age Lack of compliance with conservative management Myocardial infarction within the last 6 months or significant cardiorespiratory comorbidities In addition, surgery for cosmetic indications is not recommended given the risk of postoperative complications and chronic postoperative pain As over 100 corrective techniques have been described, the majority of the evidence concerning surgical intervention in hallux valgus involves the comparison between techniques rather than with conservative management. Small samples sizes for individual procedures have affected the feasibility of performing large scale trials comparing surgical with non-surgical management. This would also be severely limited by the lack of standardisation in the surgical arm, making the interpretation of results challenging. The only randomised controlled trial comparing operative with non-operative treatment demonstrated that surgery was significantly better than orthoses or no treatment at improving functional status, global foot assessment, pain while walking and foot deformity at 12 months 6. Key limitations of this trial were that it only included patients with mild-moderate hallux valgus, lack of medium- or long-term follow-up and the only surgical intervention that was used in comparison was the Chevron osteotomy. Imperial College Health Partners Page 3

4 The results of medium-term outcomes following hallux valgus surgery are conflicting. One study reported a patient dissatisfaction rate of 26% at 5 years post-intervention, using the Manchester-Oxford Foot Questionnaire (MOXFQ), a validated assessment tool for assess outcomes following surgery after hallux valgus 7. Meta-analysis of retrospective studies investigating various surgical techniques however have showed an overall satisfaction rate of 85% at 5 years with only 5% reporting poor results postsurgery 1. According to the Royal College of Surgeons, surgery is simpler and more successful the earlier it is performed 10. Concerning various surgical techniques, a systematic review showed that there were minimal differences in outcomes between procedures. However, all studies that were reviewed were of medium to poor quality 8. A further systematic review comparing specifically proximal versus distal metatarsal osteotomies in patients with moderate to severe hallux valgus demonstrated no significant differences in clinical and radiological outcomes between both treatments in the medium term, with similar complication rates being reported 9. Conservative management for as long as possible has been recommended in the treatment of juvenile hallux valgus due to the high risk of recurrence and of overcorrection in skeletally immature patients 11. A subsequent meta-analysis however demonstrated a relatively low recurrence rate of 8% in adolescents and reported good clinical and radiological outcomes, and a high rate of patient satisfaction 12. No comparison was made with conservative management or watchful waiting and the authors declared the evidence reviewed to be of low quality and limited in sample size. Minimally invasive techniques are now emerging as a surgical option for patients with hallux valgus. Systematic reviews on the subject suggest that these techniques produce satisfactory outcomes however the quality of the studies reviewed were generally deemed to be poor 13,14. One review concluded that complication rates appeared to be lower than those reported with open surgery in current practice, but the authors acknowledge that these procedures were largely performed in areas of high volume and technical expertise, hence the prone to bias 13. Current NICE guidance (2010) states that evidence on the efficacy of these procedures is limited and inconsistent, therefore they should only be performed if special arrangements are in place for clinical governance, consent and audit or research. Complications from hallux valgus surgery include recurrence, hallux varus, malunion and avascular necrosis. Complication rates, including recurrence, have been reported as ranging between 1-55% 15. Specifically, the rate of recurrence has been reported to be between 8-15% 16, and up to 40% of patients may still be unable to wear unlimited shoes following surgery 2. Recurrent hallux valgus requiring re-operation ranges from 2-11% 17. This appears to depend on the initial operative technique, with the highest recurrence rate being reported following correction of metatarsus primus varus with an opening wedge plate 18. A large multicentre retrospective review comparing chevron- Austin osteotomy, closing base wedge osteotomy and Lapidus arthrodesis failed to demonstrate significant differences in the rates of reoperation for hallux valgus due to recurrence or for other complications from any of these procedures 19. Review of current policies and guidelines The Royal College of Surgeons, in collaboration with the British Orthopaedic Association and British Orthopaedic Foot and Ankle Society, have published a High Imperial College Health Partners Page 4

5 Value Care Pathway on the management of the painful deformed great toe in adults 10. This pathway states that the following criteria should be fulfilled for referral for surgery: Deteriorating symptoms Functional impairment and inability to wear suitable shoes Failure of conservative management or persistent pain and disability after 12 weeks of non-surgical treatment (this is to include treatment in the primary care setting) Optimisation of significant co-morbidities prior to surgery This guideline further specifies that referrals are not to be made for prophylactic or cosmetic reasons and that age, gender, smoking status and co-morbidities should not be barriers to referral. Patients must also be engaged in a shared decision-making process and be counselled regarding inability to drive for up to 8 weeks and time required out of work. No one surgical technique has been deemed superior to any others and it is recommended that the decision on the most suitable procedure be made by an orthopaedic surgeon with expertise in foot and ankle surgery or an HCPC registered podiatric surgeon. Given the number of surgical techniques that exist and the poor quality of available evidence, the development of a streamlined policy or treatment pathway in this area remains challenging. We present our recommendations in Appendix 1. This draft policy is based on the RCS High Value Pathway (updated in 2017) and the NHSE Interim Clinical Commissioning Policy, as well as the evidence reviewed above. Delays in surgical intervention may in fact decrease efficiency due to the increased likelihood of poorer outcomes; leading to higher costs from the need for re-intervention, more intense follow-up and productivity loss. Policies from other CCG collaboratives in London are listed in Appendices 2 and 3; and the NHS England Interim Clinical Commissioning Policy for bunion surgery is listed in Appendix 3. We note that North Central London CCGs do not appear to have a policy for bunion surgery. We have also considered the NICE guideline IPG140 that concerns metatarsophalangeal joint replacement of the hallux for conditions such as rheumatoid arthritis or osteoarthritis. This subject is beyond the scope of our review and we would recommend that patients presenting with hallux valgus secondary to such conditions be treated in line with NICE guidance rather than our proposed policy for the CCGs. Next steps Given the huge diversity in surgical procedures and associated outcomes, an economic evaluation of surgery for hallux valgus will be subject to significant methodological flaws especially due to the poor quality of evidence available, and therefore of very limited value in guiding commissioning decisions. Our recommendation would be that the CCGs seek input from expert clinicians in the field in the development of this policy and perform an analysis of referral practices in North West London to identify areas with potential for efficiency gains. Imperial College Health Partners Page 5

6 References 1. Wülker N, Mittag F. The Treatment of Hallux Valgus. Dtsch Arztebl Int. 2012;109(49): Robinson AHM, Limbers JP. Modern concepts in the treatment of hallux valgus. The Journal of Bone and Joint Surgery British volume. 2005;87-B(8): Hawke F, Burns J, Radford JA, du Toit V. Custom-made foot orthoses for the treatment of foot pain. Cochrane Database of Systematic Reviews. 2008(3). 4. Reina M, Lafuente G, Munuera PV. Effect of custom-made foot orthoses in female hallux valgus after one-year follow up. Prosthetics and Orthotics International. 2012;37: Frank CJ. Hallux Valgus Treatment & Management. Medscape Drugs & Diseases Torkki M, Malmivaara A, Seitsalo S, Hoikka V, Laippala P, Paavolainen P. Surgery vs orthosis vs watchful waiting for hallux valgus: A randomized controlled trial. JAMA. 2001;285(19): Chong A, Nazarian N, Chandranath J, et al. Surgery for the correction of hallux valgus. The Bone & Joint Journal. 2015;97-B(2): Klugarova J, Hood V, Bath-Hextall F, Klugar M, Mareckova J, Kelnarova Z. Effectiveness of surgery for adults with hallux valgus deformity: a systematic review. JBI Database of Systematic Reviews and Implementation Reports. 2017;15(6): Tsikopoulos K, Papaioannou P, Kitridis D, Mavridis D, Georgiannos D. Proximal versus distal metatarsal osteotomies for moderate to severe hallux valgus deformity: a systematic review and meta-analysis of clinical and radiological outcomes. International Orthopaedics Commissioning Guide: Painful Deformed Great Toe in Adults. Royal College of Surgeons; Hecht PJ, Lin TJ. Hallux Valgus. Medical Clinics of North America. 2014;98(2): Harb Z, Kokkinakis M, Ismail H, Spence G. Adolescent hallux valgus: a systematic review of outcomes following surgery. Journal of Children's Orthopaedics. 2015;9(2): Trnka H-J, Krenn S, Schuh R. Minimally invasive hallux valgus surgery: a critical review of the evidence. International Orthopaedics. 2013;37(9): Caravelli S, Mosca M, Massimi S, et al. Percutaneous treatment of hallux valgus: What s the evidence? A systematic review. MUSCULOSKELETAL SURGERY Belczyk R, Stapleton JJ, Grossman JP, Zgonis T. Complications and Revisional Hallux Valgus Surgery. Clinics in Podiatric Medicine and Surgery. 2009;26(3): Imperial College Health Partners Page 6

7 16. Okuda R, Kinoshita M, Yasuda T, Jotoku T, Shima H, Takamura M. Hallux valgus angle as a predictor of recurrence following proximal metatarsal osteotomy. Journal of Orthopaedic Science. 2011;16(6): Duan X, Kadakia AR. Salvage of recurrence after failed surgical treatment of hallux valgus. Archives of Orthopaedic and Trauma Surgery. 2012;132(4): Wukich DK, Roussel AJ, Dial DM. Correction of Metatarsus Primus Varus with an Opening Wedge Plate: A Review of 18 Procedures. The Journal of Foot and Ankle Surgery. 2009;48(4): Lagaay PM, Hamilton GA, Ford LA, Williams ME, Rush SM, Schuberth JM. Rates of Revision Surgery Using Chevron-Austin Osteotomy, Lapidus Arthrodesis, and Closing Base Wedge Osteotomy for Correction of Hallux Valgus Deformity. The Journal of Foot and Ankle Surgery. 2008;47(4): Imperial College Health Partners Page 7

8 Appendix 1: Proposed North West London policy on the referral for bunion surgery The following criteria must be met before referral for surgical intervention: 1) Conservative management has been tried for at least three months AND 2) There is progression in pain, deformity and functional impairment despite conservative management There is involvement of the second toe or secondary foot problems such as neuritis/nerve entrapment, ulceration, or inflammatory conditions of the first metatarsal head (e.g. bursitis or tendinitis) AND 3) Significant co-morbidities (such as cardiorespiratory diseases and diabetes) have been optimised AND 4) The patient has been engaged in the shared decision-making process. This policy does not cover surgery for cosmetic purposes or asymptomatic bunions/hallux valgus. Patients with underlying arthritic changes should be treated in line with the NICE Guideline IPG140. Imperial College Health Partners Page 8

9 Appendix 2: South West London Effective Commissioning Initiative policy for Excision of Bunion (Hallux Valgus) Malignancy If there is any suspicion of malignancy, patients should be referred immediately to the appropriate service. See NICE Clinical Guideline 27: Referral Guidelines for Suspected Cancer (NICE 2005). Available at: Clinical threshold SWL CCGs fund this procedure when ALL of the following criteria (1-3) are met. 1. The patient suffers from: a) Severe deformity (with or without second toe deformity*) that causes significant functional impairment that impacts on activities of daily living** b) Severe pain to the hallux valgus, and/or to the second toe, that causes significant functional impairment**. AND 2. Conservative management has been tried and failed to resolve the condition for at least 6 months. AND 3. Patient has been engaged in shared decision making to ensure he/she is well informed about the treatment options available and personal values, preferences and circumstances are taken into consideration NB: It is recommended that the SWL Patient Decision Aid is completed. This needs to be recorded in the patient s medical notes, including the written or other materials provided. *Second toe deformity includes: Claw toe, hammer toe and mallet toe ** For the purposes of this policy, activities of daily living covers functions such as dressing, personal hygiene (washing and toileting), functional mobility (moving from one place to another to perform activities required in the home or at work) and meeting nutritional needs (shopping, preparing and eating food). Rationale for the clinical threshold This policy has been developed to ensure that resources are targeted at those with the greatest clinical need. In addition, this policy aims to reduce the variation in access to this procedure. NICE have published two interventional procedure guidance (IPG 140) concerning hallux valgus. This supports the metatarsophalangeal joint replacement of the hallux, whereas IPG 332 stresses caution for the implementation of surgical correction of hallux valgus using minimal access techniques. There are two commissioning guides, both published in November 2013, which are considered in the development of this commissioning policy. Imperial College Health Partners Page 9

10 NHS England s Interim Clinical Commissioning Policy: Bunion Surgery which was published in November This policy sets down clear criteria for the removal of symptomatic or painful bunions, this includes: Conservative methods have failed Severe deformity causing significant impairment Severe pain causing significant functional impairment. It stresses that referral for surgery should not be offered for cosmetic reasons. The British Orthopaedic Foot and Ankle Society, British Orthopaedic Association, Royal College of Surgeons of England, (2013) Commissioning guide: Painful deformed great toe in adults. The most relevant and up-to-date studies are referenced and the guidance presents a high value care pathway for painful deformed great toe with criteria for Primary Care, Intermediate Care and Secondary Care. The guide states that referral to Secondary Care should not occur for prophylactic or cosmetic reasons. Primary care advice Although primary care is not directly responsible for requesting prior approval, primary care needs to be aware of the detailed clinical criteria relating to this commissioning policy before referring the patient to the appropriate service. Primary care must also make sure that they supply the relevant information to secondary care. Conservative measures Ensure that the following conservative measures have been implemented by the clinician and/or patient over a period of 6 months: Avoiding high heels shoes, and tight pointed footwear Wearing roomier footwear with soft leather uppers Having podiatry care to remove corns and calluses The use of bunion pads to reduce irritation and protect prominent areas The use of oral analgesia to help reduce pain and inflammation Treatments for recurrent ulceration (where necessary). Prior to referral Ensure that the patient is made aware of and understands the following: There is no guarantee that the foot will be perfectly straight or pain-free after surgery That post-surgery, the patient may still not be able to wear normal shoes (or high heels) They will be out of sedentary work for 2-6 weeks, and physical work for 2-3 months They will be unable to drive for 6-8 weeks Full recovery can take an average of 4-6 months. Patients with diabetes Patients with poorly controlled diabetes should be referred for further management at the Diabetic Service and only referred for bunion surgery when their diabetes is Imperial College Health Partners Page 10

11 under control. Complication rates for patients with poorly controlled diabetes are very high for this procedure. Imperial College Health Partners Page 11

12 Appendix 3: City & Hackney, Newham, Tower Hamlets and Waltham Forest (WELC) Clinical Commissioning Groups 2016 policy for bunion surgery Criteria for funding: 1. significant pain on walking not relieved by chronic standard analgesia 2. deformity such that fitting adequate footwear is difficult 3. overlapping or underlapping of adjacent toe(s) 4. hammer toes 5. recurrent or chronic ulceration 6. bursitis or tendinitis of the first metatarsal head Imperial College Health Partners Page 12

13 Appendix 4: NHS England Interim Clinical Commissioning Policy for Bunion Surgery (2013) Referral to Orthopaedic or podiatric surgery should only be made in the following circumstances: The patient has been reviewed by local podiatry service In addition, the patient meets at least one of the following criteria: Self care advice and analgesia has been tried and symptoms are not improving Severe pain unrelieved by conservative measures Recurrent infection Recurrent ulcers Requests for the removal of symptomatic bunions will ONLY be considered where: Conservative methods have failed AND Severe deformity (overriding toes) is causing significant functional impairment* Severe pain is causing significant functional impairment* Do not offer referral or surgery for concerns about the appearance of feet. The Clinician proposing this intervention will make the decision to treat based on the criteria set out above. If the patient does not fully meet this criteria the clinician may submit an application for exceptional funding (application form and contact details on NHS Internet An annual audit will be completed to confirm that patients have been treated in accordance with these criteria. Imperial College Health Partners Page 13

BUNION (AND OTHER PAINFUL TOE CONDITION) SURGICAL TREATMENT POLICY PRIOR APPROVAL

BUNION (AND OTHER PAINFUL TOE CONDITION) SURGICAL TREATMENT POLICY PRIOR APPROVAL Version: 1718.v3 Recommendation by: Somerset CCG Clinical Commissioning Policy Forum (CCPF) Date Ratified: 12 July 2017