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Timing of surgical Intervention for developmental dysplasia of the hip: a randomised controlled trial (Hip ‘Op)

Timing of surgical Intervention for developmental dysplasia of the hip: a randomised controlled trial (Hip ‘Op)
Timing of surgical Intervention for developmental dysplasia of the hip: a randomised controlled trial (Hip ‘Op)
Background: 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 due to 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, whilst others believe that the earlier the reduction is done the better the result. Currently there is no definitive evidence to support either strategy.

Objectives: To determine, in children aged 12 weeks - 13 months, whether 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 five year follow-up. Also to perform; i) qualitative evaluation of the adopted strategy and, ii) health economic analysis based on NHS and societal costs.

Design: Phase III, unmasked randomised controlled trial with qualitative and health economics analyses. Participants were randomised 1:1 to undergo either early or delayed surgery.

Setting: Paediatric orthopaedic surgical centres in the UK.

Participants: Children aged 12 weeks - 13 months with DDH, either newly diagnosed or following failed splintage, and who required surgery. Target recruitment of 636 children.

Interventions: Surgical reduction of the hip performed as per the timing allocated at randomisation

Main outcome measures: Primary outcome - incidence of AVN at 5 years of age (Kalamchi and MacEwen classification). Secondary outcomes - 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, health economics, qualitative analysis.

Results: The trial closed early after reaching less than 5% of the target recruitment. 14 patients were randomised to early treatment and 15 to delayed. Implementation of rescue strategies did not improve recruitment. No primary outcome data were collected, and no meaningful conclusions could be made from the small amount of non-qualitative secondary outcome data. The qualitative work generated rich data around 3 key themes: access to and experiences of primary and secondary care; the impact of surgery on family life; and participants’ experiences of being in the trial.

Limitations: Over-optimistic estimates of numbers of eligible patients seen at recruiting centres during the planning of the trial, as well as an over-estimation of the recruitment rate may have also contributed to unrealistic expectations on achievable patient numbers.

Future Work: There may be scope for investigation using routinely available data

Conclusions: Hip ‘Op has highlighted how important accurate advance information on numbers of available eligible patients is, as well as support from all participating investigators is when conducting surgical research. Despite substantial consultation with parents of patients 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 ‘real life’ aspects of managing children with DDH.

Trial Registration: ISRCTN76958754

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 63. See the NIHR Journals Library website for further project information.
developmental dysplasia of the hip , DDH, ossific nucleus , ON, congenital dislocation of the hip , CDH, avascular necrosis , AVN, closed reduction, open reduction, early treatment, late treatment, intentionally delayed treatment, surgical reduction of the hip, timing of surgery for DDH
1366-5278
Williams, Charlotte L.
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Weller, Susan
6ad1e079-1a7c-41bf-8678-bff11c55142b
Roberts, Lisa
0a937943-5246-4877-bd6b-4dcd172b5cd0
Reading, Isabel
6f832276-87b7-4a76-a9ed-b4b3df0a3f66
Cook, Andrew
ab9c7bb3-974a-4db9-b3c2-9942988005d5
Little, Louisa
41f55532-898e-41a6-97c6-2802a379d684
Wood, Wendy
c7e12f30-5332-4717-a0c8-328775e06364
Stanton, Louise
8b827763-d839-4b4b-bbf2-358a84110294
Roposch, Andreas
f7449b37-9452-47e9-b695-c423b01d764b
Clarke, Nicholas M.P.
76688c21-d51e-48fa-a84d-deec66baf8ac
Williams, Charlotte L.
1f7f568c-9494-425f-8033-6947c771c884
Weller, Susan
6ad1e079-1a7c-41bf-8678-bff11c55142b
Roberts, Lisa
0a937943-5246-4877-bd6b-4dcd172b5cd0
Reading, Isabel
6f832276-87b7-4a76-a9ed-b4b3df0a3f66
Cook, Andrew
ab9c7bb3-974a-4db9-b3c2-9942988005d5
Little, Louisa
41f55532-898e-41a6-97c6-2802a379d684
Wood, Wendy
c7e12f30-5332-4717-a0c8-328775e06364
Stanton, Louise
8b827763-d839-4b4b-bbf2-358a84110294
Roposch, Andreas
f7449b37-9452-47e9-b695-c423b01d764b
Clarke, Nicholas M.P.
76688c21-d51e-48fa-a84d-deec66baf8ac

Williams, Charlotte L., Weller, Susan, Roberts, Lisa, Reading, Isabel, Cook, Andrew, Little, Louisa, Wood, Wendy, Stanton, Louise, Roposch, Andreas and Clarke, Nicholas M.P. (2017) Timing of surgical Intervention for developmental dysplasia of the hip: a randomised controlled trial (Hip ‘Op). Health Technology Assessment, 21 (63). (doi:10.3310/hta21630).

Record type: Article

Abstract

Background: 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 due to 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, whilst others believe that the earlier the reduction is done the better the result. Currently there is no definitive evidence to support either strategy.

Objectives: To determine, in children aged 12 weeks - 13 months, whether 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 five year follow-up. Also to perform; i) qualitative evaluation of the adopted strategy and, ii) health economic analysis based on NHS and societal costs.

Design: Phase III, unmasked randomised controlled trial with qualitative and health economics analyses. Participants were randomised 1:1 to undergo either early or delayed surgery.

Setting: Paediatric orthopaedic surgical centres in the UK.

Participants: Children aged 12 weeks - 13 months with DDH, either newly diagnosed or following failed splintage, and who required surgery. Target recruitment of 636 children.

Interventions: Surgical reduction of the hip performed as per the timing allocated at randomisation

Main outcome measures: Primary outcome - incidence of AVN at 5 years of age (Kalamchi and MacEwen classification). Secondary outcomes - 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, health economics, qualitative analysis.

Results: The trial closed early after reaching less than 5% of the target recruitment. 14 patients were randomised to early treatment and 15 to delayed. Implementation of rescue strategies did not improve recruitment. No primary outcome data were collected, and no meaningful conclusions could be made from the small amount of non-qualitative secondary outcome data. The qualitative work generated rich data around 3 key themes: access to and experiences of primary and secondary care; the impact of surgery on family life; and participants’ experiences of being in the trial.

Limitations: Over-optimistic estimates of numbers of eligible patients seen at recruiting centres during the planning of the trial, as well as an over-estimation of the recruitment rate may have also contributed to unrealistic expectations on achievable patient numbers.

Future Work: There may be scope for investigation using routinely available data

Conclusions: Hip ‘Op has highlighted how important accurate advance information on numbers of available eligible patients is, as well as support from all participating investigators is when conducting surgical research. Despite substantial consultation with parents of patients 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 ‘real life’ aspects of managing children with DDH.

Trial Registration: ISRCTN76958754

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 63. See the NIHR Journals Library website for further project information.

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Accepted/In Press date: 11 June 2017
e-pub ahead of print date: 25 October 2017
Published date: 25 October 2017
Keywords: developmental dysplasia of the hip , DDH, ossific nucleus , ON, congenital dislocation of the hip , CDH, avascular necrosis , AVN, closed reduction, open reduction, early treatment, late treatment, intentionally delayed treatment, surgical reduction of the hip, timing of surgery for DDH

Identifiers

Local EPrints ID: 412314
URI: http://eprints.soton.ac.uk/id/eprint/412314
ISSN: 1366-5278
PURE UUID: 45cf589f-623e-4c19-beef-1f07bd691617
ORCID for Susan Weller: ORCID iD orcid.org/0000-0002-6839-876X
ORCID for Isabel Reading: ORCID iD orcid.org/0000-0002-1457-6532
ORCID for Andrew Cook: ORCID iD orcid.org/0000-0002-6680-439X
ORCID for Louise Stanton: ORCID iD orcid.org/0000-0001-8181-840X

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Date deposited: 17 Jul 2017 13:28
Last modified: 17 Mar 2021 02:46

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