Clinical Cmmissining Grup (CCG) Treatment Plicy NHS Birmingham and Slihull Clinical Cmmissining Grup NHS Sandwell and West Birmingham Clinical Cmmissining Grup DRAFT Plicy fr Asymptmatic & Symptmatic Bunins 1
Clinical Cmmissining Grup (CCG) Treatment Plicy Dcument Details: Versin: DRAFT v8. Ratified by (name and date f Cmmittee): Treatment Plicy Clinical Develpment Grup 5 th April 2018 Date issued fr Public Cnsultatin: 14 th May 2018 Equality & Diversity Impact Assessment 13 th April 2018 The CCG plicy has been reviewed and develped by the Treatment Plicies Clinical Develpment Grup in line with the grups guiding principles which are: 1. CCG Cmmissiners require clear evidence f clinical effectiveness befre NHS resurces are invested in the treatment; 2. CCG Cmmissiner require clear evidence f cst effectiveness befre NHS resurces are invested in the treatment; 3. The cst f the treatment fr this patient and thers within any anticipated chrt is a relevant factr; 4. CCG Cmmissiners will cnsider the extent t which the individual r patient grup will gain a benefit frm the treatment; 5. CCG Cmmissiners will balance the needs f each individual against the benefit which culd be gained by alternative investment pssibilities t meet the needs f the cmmunity 6. CCG Cmmissiners will cnsider all relevant natinal standards and take int accunt all prper and authritative guidance; 7. Where a treatment is apprved CCG Cmmissiners will respect patient chice as t where a treatment is delivered; AND 8. All plicy decisins are cnsidered within the wider cnstraints f the CCG s legally respnsibility t remain fiscally respnsible. 2
Clinical Cmmissining Grup (CCG) Treatment Plicy Categry: Restricted Bunins Hallux valgus is the deviatin f the big te (the hallux) away frm the mid-line twards the lesser tes. The metatarsal head drifts twards the midline and this tgether with its verlying bursa and inflamed sft tissue is knwn as the bunin, which causes pain and rubbing n shes. Hallux rigidus is the develpment f arthritic changes within the jint causing stiffness, pain and defrmity. Hallux valgus and rigidus are frequently accmpanied by lesser te changes such as hammer r claw tes and abnrmal weight distributin under the lesser tes which can be painful (metatarsalgia). Hallux valgus (deviatin f the big te)) is ften accmpanied with, r mistaken fr, hallux interphalangeus, where the tip f the big te is deviated laterally (mved t ne side), althugh symptms may be similar. Defrmity may cntribute t impaired balance, which can increase the incidence f falls. Untreated hallux valgus defrmity in patients with diabetes (and ther causes f peripheral neurpathy) may lead t ulceratin, deep infectin and even belw knee amputatin. Bunins are cmmn, and mre s in advanced age and in females. Prevalence has been estimated at 23% in adults aged 18-65 years and 35.7% in thse aged ver 65 years. Ftwear ften cntributes t this prblem. Patients with hallux valgus and rigidus have wrse pain than the general ppulatin. Surgery can imprve the quality f life in this grup. Overall satisfactin rates fllwing surgery are gd (mre than 80% in mst studies), but studies are small and fllw up shrt. The exact cause f bunins is unknwn, but they tend t run in families. Wearing badly fitting shes is thught t make bunins wrse. It's als thught that bunins are mre likely t ccur in peple with unusually flexible jints, which is why bunins smetimes ccur in children. In sme cases, certain health cnditins, such as rheumatid arthritis and gut, may als be respnsible. There are a number f treatment ptins fr hallux vagus (bunins). Nn-surgical treatments include painkillers, rthtics (insles) and bunin pads. While surgery is usually effective (symptms are imprved in 85% f cases), bunins can smetimes return. Cmplicatins ccur after bunin surgery. These will depend n the type f surgery the patient has had and can include: stiffness in the te jints a delay r failure f the bne t heal r the bne healing in the wrng psitin pain under the ball f the ft damage t the nerves in the ft prlnged swelling and cntinued pain the need fr further surgery 3
Clinical Cmmissining Grup (CCG) Treatment Plicy The best way t reduce the patient s chances f develping bunins is t wear shes that fit prperly. Shes that are t tight r have high heels can frce the patient s tes tgether. Primary Care Assessment The diagnsis f a bunin is usually based n clinical findings. Nt all peple with bunins have symptms. Examine the persn bth sitting dwn and standing (standing up may exaggerate the defrmity). Lk fr: Lateral deviatin f the first te at the metatarsphalangeal (MTP) jint. Mvement f the first te twards the secnd te. Prminence f the first metatarsal head. Medial bursitis ver the first MTP jint (as a result f irritatin frm shes). Rule ut alternative diagnses, such as: Hallux rigidus (arthritis f the metatarsphalangeal jint). Gut. Sesamiditis. Fractures. Rheumatlgical disease. Neurlgical pain (may be related t diabetes). Infectin. Assessment Establish the reasn fr cnsultatin. The persn may: Require symptmatic relief nly. Have difficulty in fitting int ftwear (resulting in skin trauma). Have n symptms but dislike the lk f their ft r the type f ftwear that must be wrn t accmmdate the ft. Assess the severity f the bunin(s). Ask abut: The duratin f pain and the presence f paraesthesia (nt all peple with bunins are symptmatic).the patient may reprt medial first metatarsphalangeal (MTP) jint r plantar ft pain, which is ften wrse when wearing shes, may ccur n weight bearing, and may be described as deep and aching if assciated with jint degeneratin. The effect f symptms n the patient's lifestyle and activities. 4
Clinical Cmmissining Grup (CCG) Treatment Plicy Assess the degree f defrmity. This depends n the extent f lateral deviatin f the prximal phalanx frm the first metatarsal (this can be frmally measured using weight-bearing X-ray images, usually dne in secndary care if referral is necessary). Als check fr invlvement f the secnd te (may be at risk f dislcatin). Assess fr degenerative jint disease (which may develp in peple with lng-standing r severe bunins). Ask the persn t stand n tipte if they are able (stiffness f the first MTP jint may indicate stearthritis). Enquire abut a medical histry f diabetes, vascular disease, r neurpathy, and check fr: Skin quality (ft ulceratin can ccur if there are areas f skin breakdwn). Calluses r crns (indicate pints f verlad). Pulses and sensatin. Assess ftwear, and ask what types f shes are nrmally wrn and whether there has been any recent change in ftwear. Enquire abut treatments that have already been tried, such as bunin pads r ver-thecunter analgesics Management Advise patients presenting with bunins that: They shuld wear lw-heeled, wide shes with a sft sle. Bunins can be prgressive. Nn-surgical treatments (fr example medicatin, bunin pads, rthses) may relieve symptms but d nt limit prgressin. If the patient is symptmatic: Offer ral analgesia (fr example paracetaml r a nnsteridal anti-inflammatry drug, such as ibuprfen). Advise self-care treatments fr symptmatic relief, such as bunin pads (available verthe-cunter) r ice packs. Cnsider referral t pdiatry fr ftwear advice r cnsideratin f a night splint r rthsis. Offer written infrmatin, i.e. CCG patient infrmatin leaflet. If analgesia and self-care measures are nt effective, cnsider referral. Advise the persn that: Referral fr bunin surgery is indicated fr symptmatic bunins (see eligibility criteria belw) and is nt rutinely cmmissined fr csmetic purpses. Cnservative treatment may be mre apprpriate than surgery fr sme lder peple, r peple with severe neurpathy r ther cmrbidities affecting their ability t underg surgery. 5
Clinical Cmmissining Grup (CCG) Treatment Plicy Refer fr rthpaedic r pdiatric surgery cnsultatin accrding t lcal plicy and service prvisin. Situatins where referral may be f benefit include if: The defrmity is painful and wrsening. The secnd te is invlved. The persn has difficulty btaining suitable shes. There is significant disruptin t lifestyle r activities. If the patient is referred fr cnsideratin f surgery, advise that: Surgery is usually dne as a day case. Bunin surgery is ne f the mst cmmnly-perfrmed ft and ankle prcedures. It may help relieve pain and imprve the alignment f the te in mst peple (85% 90%); hwever, there is n guarantee that the ft will be perfectly straight r pain-free after surgery. Cmplicatins after bunin surgery may include infectin, jint stiffness, transfer pain (pain under the ball f the ft), hallux varus (vercrrectin), bunin recurrence, damage t the nerves, and cntinued lng-term pain. Refer t a diabetic ft prtectin service if the persn has diabetes. 6
Clinical Cmmissining Grup (CCG) Treatment Plicy Intermediate Care Cmmunity Ft Health Service Cmmissined services must be integrated int a multidisciplinary netwrk and include the skills fr example: Muscskeletal (MSK) physitherapy Pdiatry (nn-surgical and surgical) Orthtics Rheumatlgy Orthpaedic surgery Assessment: Histry - as abve Examinatin: As abve Examine fr metatarsalgia Lesser te defrmity Overall lwer leg alignment Presence f tibialis psterir dysfunctin Investigatin - weight bearing X-rays (nly if indicated, such as t guide injectin) Management: Prviders must adpt a shared decisin making mdel, define treatment gals and take int accunt persnal circumstances. Patient infrmatin shuld be prvided. Ftwear assessment and prvisin f fflading rthtics as apprpriate. Physitherapy: Balance, prpriceptin, and cre stability, calf muscle stretches, and t treat features f tibialis psterir tendn dysfunctin. Injectins: Only indicated if inflammatin r arthritis is suspected r if patient unfit fr surgery. Cntraindicated if infectin is suspected. Radigraphs (X-rays) shuld be perfrmed prir t prcedure. Refer fr surgery: Deterirating symptms. Failure f apprpriate cnservative measures after three mnths. Persistent pain and disability nt respnding t up t 12 weeks f nn-surgical treatments; this time t include any treatment received in primary care. Patient must be prepared t underg surgery understanding that they will be ut f sedentary wrk fr 2-6 weeks and physical wrk fr 2-3 mnths and they will be unable t drive fr 6-8 weeks (2 weeks if left ft and driving autmatic car). Age, gender, smking, besity and c-mrbidity shuld nt be barriers t referral. Patients with significant c-mrbidities [systemic r lcal] shuld have treatment which ptimises these befre referral. Fr clarificatin, c-mrbidities must be managed thrugh a shared decisin making prcess with the patient, enabling patients t make jint decisins n referral and treatment. Patients wh are nt suitable fr surgery shuld be referred fr a cmplex care package. 7
Clinical Cmmissining Grup (CCG) Treatment Plicy Secndary Care Assessment: Histry - as abve, diagnsis cnfirmed. Examinatin - as abve, ther pathlgies excluded. Investigatins: Weight bearing X-rays and; Further imaging (e.g.: Ultrasund, MRI) as indicated. Management: Prviders must adpt a shared decisin making mdel, define treatment gals and take int accunt persnal circumstances, all alternatives MUST be discussed. Patient infrmatin shuld be prvided. Surgery: Criteria fr interventin are the same as the criteria fr referral. MUST NOT be undertaken fr prphylactic r csmetic reasns. Shuld be undertaken by rthpaedic surgens trained in ft and ankle surgery r Health and Care Prfessins Cuncil registered pdiatric surgens (CCPST), integrated int a multi-disciplinary netwrk. Is usually day case r 23-hur admissin, unless clinical r scial circumstances dictate therwise. A minimum f 3 utpatient fllw up appintments by apprpriately experienced ft and ankle clinicians. Review f standing radigraphs within 8 weeks by surgen. It is recmmended that PROM (Patient Reprted Outcme Measures) scres be recrded at least 12 mnths fllwing surgical episde. There are a number f surgical ptins.. The prcedure selected will depend n: patient symptms/signs and patient chice having cnsidered with the surgen the risk and benefits f each. These require apprpriate facilities. There is n cnclusive evidence fr the superirity f ne peratin ver anther. Surgery is simpler and mre successful in the earlier stages f defrmity. Recurrence f defrmity after buninsurgery ccurs in 8-15% f patients. Nn-unin f fusin fr hallux rigidus ccurs in up t 10% f cases. Cmplex surgery (e.g. cmplex revisin infectin with bne lss avascular necrsis and neurlgical defrmity) must be undertaken by surgens with a recrded interest in cmplex ft and ankle surgery wrking in high vlume centre with apprpriate facilities. Minimal access techniques must nly be undertaken as part f a research prject r where special arrangements fr audit are in place (NICE IPG 332). In cases f pst-perative cmplicatins, primary care shuld ideally be able t refer the patient back t the same surgical team, shuld the patient want this. Patients shuld be infrmed that the decisin t have surgery can be a dynamic prcess and a decisin t nt underg surgery des nt exclude them frm having surgery at a future time pint. 8
Clinical Cmmissining Grup (CCG) Treatment Plicy Eligibility Criteria: Surgery fr Asymptmatic Hallux Valgus (Bunins) is nt rutinely cmmissined. If the patient has diagnsed diabetes and presents with an asymptmatic bunin the patient shuld be referred t a cmmunity ft health service. Surgery fr Symptmatic Hallux Valgus (Bunins) will be funded in the fllwing circumstances: The patient has a cnfirmed diagnsis f a bunin AND The patient has deterirating symptms AND ALL Cnservative measures have failed after three mnths AND The patient is experiencing persistent pain and disability due t the hallux valgus, which is causing functinal impairment and has nt respnded fllwing 12 weeks f cnservative measures AND The patient must be prepared t underg surgery, understanding that they will be ut f sedentary wrk fr 2-6 weeks and physical wrk fr 2-3 mnths and they will be unable t drive fr 6-8 weeks (2 weeks if left ft and driving autmatic car) AND Weight bearing X-rays have been undertaken prir t surgery. AND The prvider has adpted a shared decisin making mdel, with defined treatment gals and has taken int accunt persnal circumstances, with ALL alternatives discussed with the patient ANDThe prcedure will be undertaken by rthpaedic surgens trained in ft and ankle surgery r Health and Care Prfessins Cuncil registered pdiatric surgens (CCPST), integrated int a multi-disciplinary netwrk. Deterirating symptms are defined fr the purpses f this plicy as the fllwing: mderate r severe pain AND functinal impairment AND redness/sreness OR Bigger demrmatin, 2 nd te affected/lifting OR Callus under 2 nd MTPJ. Cnservative measures are defined fr the purpses f this plicy as the fllwing: Ensure ftwear is apprpriate (lwer heels; wider fitting shes; mulded shes) AND the patient has been advised n and has trialled patient directed apprach (bunin pads, ver the cunter analgesia, ice t relieve pain and inflammatin) AND referral t pdiatry fr fflading rthtics has been exhausted AND the patient has been prvided with the patient leaflet. Functinal impairment is defined as interfering with activities f daily living, i.e. sleeping; eating; walking. N.B.: Current evidence n the efficacy f surgical crrectin f hallux valgus using minimal access techniques is limited and incnsistent. In additin, the evidence relates t a range f different surgical techniques. The evidence n safety is inadequate. (NICE 2010). 9
Clinical Cmmissining Grup (CCG) Treatment Plicy Therefre, surgical crrectin f hallux valgus using minimal access techniques is Nt Rutinely Cmmissined in any circumstances. N.B. The evidence review undertaken demnstrated gd fllw-up data regarding patient reprted utcmes, but an area fr further research was identified regarding lnger-term fllw-up data. Therefre prviders undertaking surgery fr bunins will be required t submit a reprt t the CCG which encmpasses fllw-up patient reprted utcmes at 1 year; 2 years; 3 years; 4 years & 5 years. This means (fr patients wh DO NOT meet the abve criteria ) the CCG will nly fund the treatment if an Individual Funding Request (IFR) applicatin prves exceptinal clinical need and that is supprted by the CCG. 10
Clinical Cmmissining Grup (CCG) Treatment Plicy Guidance: British Orthpaedic Ft & Ankle Sciety, British Orthpaedic Assciatin (BOA), Ryal Cllege f Surgens f England (RCSEng) 2017. Cmmissining Guide: Painful Defrmed Great Te in Adults. Crevisier, X., Assal, M., & Stanekva, K. (2016). Hallux valgus, ankle stearthrsis and adult acquired flatft defrmity: a review f three cmmn ft and ankle pathlgies and their treatments. EFORT Open Reviews, 1(3), 58 64. http://di.rg/10.1302/2058-5241.1.000015 ElMakki Ahmed, M.1, Tamimi, A.O., Mahadi, S.I., Widatalla, A.H., Shawer, M.A. (2010). Hallux ulceratin in diabetic patients. Jurnal f Ft and Ankle Surgery. Jan-Feb;49(1):2-7. di: 10.1053/j.jfas.2009.07.005 Ferrari, J. (2009). Bunins. BMJ Clinical Evidence, 2009, 1112. Harb, Z., Kkkinakis, M., Ismail, H., & Spence, G. (2015). Adlescent hallux valgus: a systematic review f utcmes fllwing surgery. Jurnal f Children s Orthpaedics, 9(2), 105 112. http://di.rg/10.1007/s11832-015-0655-y Klugarva J, Hd V, Bath-Hextall F, Klugar M, Mareckva J, Kelnarva Z. (2017). Effectiveness f surgery fr adults with hallux valgus defrmity: a systematic review. JBI Database f Systematic Reviews and Implementatin Reprts. Jun;15(6):1671-1710. di: 10.11124/JBISRIR-2017-003422. NHS Chices. 2017. Bunins. https://www.nhs.uk/cnditins/bunin/ NICE 2016. Clinical Knwledge Summaries. Bunins. https://cks.nice.rg.uk/bunins#!scenarirecmmendatin:1 NICE Guideline, N. 19. Diabetic ft prblems: preventin and management. Natinal Institute fr Health and Care Excellence (UK); 2015 August. NICE 2010. Surgical crrectin f hallux valgus using minimal access techniques. Interventinal prcedures guidance. IPG332. nice.rg.uk/guidance/ipg332 Nix, S., Smith, M., & Vicenzin, B. (2010). Prevalence f hallux valgus in the general ppulatin: a systematic review and meta-analysis. Jurnal f Ft and Ankle Research, 3, 21. http://di.rg/10.1186/1757-1146-3-21 Surgical crrectin f hallux valgus using minimal access techniques. Interventinal prcedures guidance [IPG332]. Natinal Institute fr Health and Care Excellence (UK). February 2010. Klugarva J, Hd V, Bath-Hextall F, Klugar M, Mareckva J, Kelnarva Z. (2017). Effectiveness f surgery fr adults with hallux valgus defrmity: a systematic review. JBI Database f Systematic Reviews and Implementatin Reprts. Jun;15(6):1671-1710. di: 10.11124/JBISRIR-2017-003422. 11