{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T02:58:29Z","timestamp":1791773909433,"version":"4.3.4"},"reference-count":26,"publisher":"National Institute for Health and Care Research","issue":"63","license":[{"start":{"date-parts":[[2017,10,1]],"date-time":"2017-10-01T00:00:00Z","timestamp":1506816000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["11\/146\/01"],"award-info":[{"award-number":["11\/146\/01"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title><jats:p>Developmental dysplasia of the hip (DDH) is a very common congenital disorder, and late-presenting cases often require surgical treatment. Surgical reduction of the hip may be complicated by avascular necrosis (AVN), which occurs as a result of interruption to the femoral head blood supply during treatment and can result in long-term problems. Some surgeons delay surgical treatment until the ossific nucleus (ON) has developed, whereas others believe that the earlier the reduction is performed, the better the result. Currently there is no definitive evidence to support either strategy.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-2\"><jats:title>Objectives<\/jats:title><jats:p>To determine, in children aged 12 weeks to 13 months, whether or not delayed surgical treatment of a congenitally dislocated hip reduces the incidence of AVN at 5 years of age. The main clinical outcome measures were incidence of AVN and the need for a secondary surgical procedure during 5 years\u2019 follow-up. In addition, to perform (1) a qualitative evaluation of the adopted strategy and (2) a health economic analysis based on NHS and societal costs.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-3\"><jats:title>Design<\/jats:title><jats:p>Phase III, unmasked, randomised controlled trial with qualitative and health economics analyses. Participants were randomised 1\u2009:\u20091 to undergo either early or delayed surgery.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-4\"><jats:title>Setting<\/jats:title><jats:p>Paediatric orthopaedic surgical centres in the UK.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-5\"><jats:title>Participants<\/jats:title><jats:p>Children aged 12 weeks to 13 months with DDH, either newly diagnosed or following failed splintage, and who required surgery. We had a target recruitment of 636 children.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-6\"><jats:title>Interventions<\/jats:title><jats:p>Surgical reduction of the hip performed as per the timing allocated at randomisation.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-7\"><jats:title>Main outcome measures<\/jats:title><jats:p>Primary outcome \u2013 incidence of AVN at 5 years of age (according to the Kalamchi and MacEwen classification). Secondary outcomes \u2013 need for secondary surgery, presence or absence of the ON at the time of primary treatment, quality of life for the main carer and child, and a health economics and qualitative analysis.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-8\"><jats:title>Results<\/jats:title><jats:p>The trial closed early after reaching &lt;\u20095% of the recruitment target. Fourteen patients were randomised to early treatment and 15 to delayed treatment. Implementation of rescue strategies did not improve recruitment. No primary outcome data were collected, and no meaningful conclusions could be made from the small number of non-qualitative secondary outcome data. The qualitative work generated rich data around three key themes: (1) access to, and experiences of, primary and secondary care; (2) the impact of surgery on family life; and (3) participants\u2019 experiences of being in the trial.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-9\"><jats:title>Limitations<\/jats:title><jats:p>Overoptimistic estimates of numbers of eligible patients seen at recruiting centres during the planning of the trial, as well as an overestimation of the recruitment rate, may have also contributed to unrealistic expectations on achievable patient numbers.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-10\"><jats:title>Future work<\/jats:title><jats:p>There may be scope for investigation using routinely available data.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-11\"><jats:title>Conclusions<\/jats:title><jats:p>Hip \u2019Op has highlighted the importance of accurate advance information on numbers of available eligible patients, as well as support from all participating investigators when conducting surgical research. Despite substantial consultation with parents of children in the planning stage, the level of non-participation experienced during recruitment was much higher than anticipated. The qualitative work has emphasised the need for appropriate advice and robust support for parents regarding the \u2018real-life\u2019 aspects of managing children with DDH.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-12\"><jats:title>Trial registration<\/jats:title><jats:p>Current Controlled Trials ISRCTN76958754.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-13\"><jats:title>Funding<\/jats:title><jats:p>This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in<jats:italic>Health Technology Assessment<\/jats:italic>; Vol. 21, No. 63. See the NIHR Journals Library website for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta21630","type":"journal-article","created":{"date-parts":[[2017,10,25]],"date-time":"2017-10-25T12:39:23Z","timestamp":1508935163000},"page":"1-84","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Timing of surgical intervention for developmental dysplasia of the hip: a randomised controlled trial (Hip \u2019Op)"],"prefix":"10.3310","volume":"21","clinical-trial-number":[{"clinical-trial-number":"isrctn76958754","registry":"10.18810\/isrctn","type":"results"}],"author":[{"given":"Charlotte L","family":"Williams","sequence":"first","affiliation":[{"name":"Southampton Clinical Trials Unit, School of Medicine, University of Southampton, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susie","family":"Weller","sequence":"additional","affiliation":[{"name":"Faculty of Health Sciences, University of Southampton, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Roberts","sequence":"additional","affiliation":[{"name":"Faculty of Health Sciences, University of Southampton, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabel","family":"Reading","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, University of Southampton, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Cook","sequence":"additional","affiliation":[{"name":"Wessex Institute, University of Southampton, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louisa","family":"Little","sequence":"additional","affiliation":[{"name":"Southampton Clinical Trials Unit, School of Medicine, University of Southampton, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendy","family":"Wood","sequence":"additional","affiliation":[{"name":"Southampton Clinical Trials Unit, School of Medicine, University of Southampton, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louise","family":"Stanton","sequence":"additional","affiliation":[{"name":"Southampton Clinical Trials Unit, School of Medicine, University of Southampton, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Roposch","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Great Ormond Street Hospital for Children, Institute of Child Health, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas MP","family":"Clarke","sequence":"additional","affiliation":[{"name":"Paediatric Orthopaedics, University Hospital Southampton NHS Foundation Trust, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2017,10]]},"reference":[{"key":"key20171024154308451_ref1-bib1","doi-asserted-by":"publisher","first-page":"423","DOI":"10.1136\/archdischild-2011-301085","article-title":"Twenty years experience of selective secondary ultrasound screening for congenital dislocation of the hip","volume":"97","author":"Clarke","year":"2012","journal-title":"Arch Dis Child"},{"key":"key20171024154308451_ref1-bib2","doi-asserted-by":"crossref","first-page":"1527","DOI":"10.1136\/bmj.285.6354.1527","article-title":"Congenital hip dislocation: an increasing and still uncontrolled disability?","volume":"285","author":"Catford","year":"1982","journal-title":"Br Med J"},{"key":"key20171024154308451_ref1-bib3","doi-asserted-by":"crossref","first-page":"876","DOI":"10.2106\/00004623-198062060-00002","article-title":"Avascular necrosis following treatment of congenital dislocation of the hip","volume":"62","author":"Kalamchi","year":"1980","journal-title":"J Bone Joint Surg Am"},{"key":"key20171024154308451_ref1-bib4","doi-asserted-by":"crossref","first-page":"911","DOI":"10.2106\/JBJS.H.00096","article-title":"The effect of the femoral head ossific nucleus in the treatment of developmental dysplasia of the hip. A meta-analysis","volume":"91","author":"Roposch","year":"2009","journal-title":"J Bone Joint Surg Am"},{"key":"key20171024154308451_ref1-bib5","doi-asserted-by":"publisher","first-page":"676","DOI":"10.1097\/BPO.0b013e3181efb8c7","article-title":"Late reduction in congenital dislocation of the hip and the need for secondary surgery: radiologic predictors and confounding variables","volume":"30","author":"Bolland","year":"2010","journal-title":"J Pediatr Orthop"},{"key":"key20171024154308451_ref1-bib6","doi-asserted-by":"publisher","first-page":"1005","DOI":"10.1007\/s11136-005-5994-6","article-title":"The CarerQol instrument: a new instrument to measure care-related quality of life of informal caregivers for use in economic evaluations","volume":"15","author":"Brouwer","year":"2006","journal-title":"Qual Life Res"},{"key":"key20171024154308451_ref1-bib7","first-page":"335","article-title":"The creation, validation, and continuing development of the Oucher: a measure of pain intensity in children","volume":"7","author":"Beyer","year":"1992","journal-title":"J Pediatr Nurs"},{"key":"key20171024154308451_ref1-bib8","volume-title":"PedsQL\u2122 (Pediatric Quality of Life Inventory\u2122)","author":"Varni"},{"key":"key20171024154308451_ref1-bib9","doi-asserted-by":"publisher","first-page":"375","DOI":"10.3109\/07853890109002092","article-title":"The Health Utilities Index (HUI\u00ae) system for assessing health-related quality of life in clinical studies","volume":"33","author":"Furlong","year":"2009","journal-title":"Ann Med"},{"key":"key20171024154308451_ref1-bib10","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1002\/(SICI)1099-1050(199707)6:4<327::AID-HEC282>3.0.CO;2-W","article-title":"Pulling cost-effectiveness analysis up by its bootstraps: a non-parametric approach to confidence interval estimation","volume":"6","author":"Briggs","year":"1997","journal-title":"Health Economics"},{"key":"key20171024154308451_ref1-bib11","doi-asserted-by":"crossref","first-page":"e145","DOI":"10.2106\/JBJS.J.01623","article-title":"Functional outcomes in children with osteonecrosis secondary to treatment of developmental dysplasia of the hip","volume":"93","author":"Roposch","year":"2011","journal-title":"J Bone Joint Surg Am"},{"key":"key20171024154308451_ref1-bib12","doi-asserted-by":"crossref","first-page":"295","DOI":"10.1097\/01.blo.0000223975.13960.2d","article-title":"The role of the ossific nucleus in the treatment of established hip dislocation","volume":"449","author":"Roposch","year":"2006","journal-title":"Clin Orthop Relat Res"},{"issue":"20","key":"key20171024154308451_ref1-bib13","doi-asserted-by":"crossref","DOI":"10.3310\/hta2200","article-title":"Primary total hip replacement surgery: a structured review of outcomes and modelling of cost-effectiveness associated with different prostheses","volume":"2","author":"Fitzpatrick","year":"1999","journal-title":"Health Technol Assess"},{"issue":"26","key":"key20171024154308451_ref1-bib14","doi-asserted-by":"crossref","DOI":"10.3310\/hta12260","article-title":"A systematic review of the clinical effectiveness and cost-effectiveness and economic modelling of minimal incision total hip replacement approaches in the management of arthritic disease of the hip","volume":"12","author":"de Verteuil","year":"2008","journal-title":"Health Technol Assess"},{"key":"key20171024154308451_ref1-bib15","doi-asserted-by":"crossref","DOI":"10.1093\/oso\/9780198526629.001.0001","volume-title":"Decision Modelling for Health Economic Evaluation","author":"Briggs","year":"2006"},{"key":"key20171024154308451_ref1-bib16","volume-title":"Hip Op Patient Information Video","author":"SCTU","year":"2014"},{"key":"key20171024154308451_ref1-bib17","doi-asserted-by":"publisher","first-page":"283","DOI":"10.1186\/s13063-016-1391-4","article-title":"Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI)","volume":"17","author":"Donovan","year":"2016","journal-title":"Trials"},{"key":"key20171024154308451_ref1-bib18","volume-title":"Household Disposable Income and Inequality","author":"Office for National Statistics","year":"2016"},{"key":"key20171024154308451_ref1-bib19","volume-title":"Maternity and Paternity Rights Survey and Women Returners Survey 2009\/10","author":"Chanfreau","year":"2011"},{"key":"key20171024154308451_ref1-bib20","volume-title":"Sibling Development: Implications for Mental Health Practitioners","author":"Caspi","year":"2010"},{"key":"key20171024154308451_ref1-bib21","doi-asserted-by":"publisher","first-page":"45","DOI":"10.1016\/j.socscimed.2016.08.042","article-title":"Social class, employment status and inequality in psychological well-being in the UK: cross-sectional and fixed effects analyses over two decades","volume":"167","author":"Richards","year":"2016","journal-title":"Soc Sci Med"},{"key":"key20171024154308451_ref1-bib22","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1186\/1745-6215-11-31","article-title":"Reasons for participating in randomised controlled trials: conditional altruism and considerations for self","volume":"11","author":"McCann","year":"2010","journal-title":"Trials"},{"key":"key20171024154308451_ref1-bib23","doi-asserted-by":"crossref","first-page":"1337","DOI":"10.1016\/S0277-9536(97)00063-4","article-title":"Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial","volume":"45","author":"Snowdon","year":"1997","journal-title":"Soc Sci Med"},{"key":"key20171024154308451_ref1-bib24","doi-asserted-by":"crossref","first-page":"709","DOI":"10.1016\/S0277-9536(01)00197-6","article-title":"\u2018Why don\u2019t they just tell me straight, why allocate it?\u2019 The struggle to make sense of participating in a randomised controlled trial","volume":"55","author":"Featherstone","year":"2002","journal-title":"Soc Sci Med"},{"key":"key20171024154308451_ref1-bib25","doi-asserted-by":"crossref","first-page":"36","DOI":"10.7748\/ns.29.44.36.e9251","article-title":"Use of diaries in research","volume":"29","author":"Snowden","year":"2015","journal-title":"Nurs Stand"},{"key":"key20171024154308451_ref1-bib26","volume-title":"The Potentials and Pitfalls of using Skype for Qualitative (Longitudinal) Interviews","author":"Weller","year":"2015"}],"container-title":["Health Technology Assessment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/publications\/hta21630\/hta21630.xml","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2002749","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/publications\/hta21630\/hta21630.xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2011364","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,6,28]],"date-time":"2024-06-28T00:55:26Z","timestamp":1719536126000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/hta\/hta21630"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,10]]},"references-count":26,"journal-issue":{"issue":"63","published-online":{"date-parts":[[2017,10]]}},"alternative-id":["10.3310\/hta21630"],"URL":"https:\/\/doi.org\/10.3310\/hta21630","relation":{},"ISSN":["1366-5278","2046-4924"],"issn-type":[{"value":"1366-5278","type":"print"},{"value":"2046-4924","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,10]]},"assertion":[{"value":"This content has been made freely available to all.","name":"free","label":"Free to read"}]}}