One-stage or two-stage revision surgery for prosthetic hip joint infection--the INFORM trial: a study protocol for a randomised controlled trial

Trials
Simon StrangeAshley Blom

Abstract

Periprosthetic joint infection (PJI) affects approximately 1% of patients following total hip replacement (THR) and often results in severe physical and emotional suffering. Current surgical treatment options are debridement, antibiotics and implant retention; revision THR; excision of the joint and amputation. Revision surgery can be done as either a one-stage or two-stage operation. Both types of surgery are well-established practice in the NHS and result in similar rates of re-infection, but little is known about the impact of these treatments from the patient's perspective. The main aim of this randomised controlled trial is to determine whether there is a difference in patient-reported outcome measures 18 months after randomisation for one-stage or two-stage revision surgery. INFORM (INFection ORthopaedic Management) is an open, two-arm, multi-centre, randomised, superiority trial. We aim to randomise 148 patients with eligible PJI of the hip from approximately seven secondary care NHS orthopaedic units from across England and Wales. Patients will be randomised via a web-based system to receive either a one-stage revision or a two-stage revision THR. Blinding is not possible due to the nature of the intervention. All patie...Continue Reading

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Citations

Jun 28, 2016·Acta Orthopaedica·Eivind Witsø
Dec 4, 2019·Orthopaedic Surgery·Hao-Yang WangZong-Ke Zhou
Jun 24, 2016·Clinical Orthopaedics and Related Research·Moataz El-Husseiny, Fares S Haddad
May 2, 2018·Current Rheumatology Reports·Ashley E LevackAlberto V Carli
Aug 12, 2020·Hip International : the Journal of Clinical and Experimental Research on Hip Pathology and Therapy·Dimitrios SotiriouGösta Ullmark
May 5, 2018·British Journal of Hospital Medicine·Hosam E MatarNicholas Emms
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Mar 31, 2019·Archives of Orthopaedic and Trauma Surgery·Konstantinos Anagnostakos, Christof Meyer
Sep 27, 2018·World Journal of Orthopedics·Thomas Baad-HansenJohnny Keller
Jul 11, 2018·Current Reviews in Musculoskeletal Medicine·Fiachra E RowanFares S Haddad
Apr 7, 2018·European Journal of Epidemiology·Setor K KunutsorUNKNOWN Global Infection Orthopaedic Management Collaboration
Jan 13, 2021·The Journal of Bone and Joint Surgery. American Volume·Amit AtreyUNKNOWN GAIA (Global Arthroplasty Infection Association) Registry Group
Jun 15, 2017·Deutsches Ärzteblatt International·Christina Otto-LambertzNorma Jung
Apr 2, 2020·Materials Science & Engineering. C, Materials for Biological Applications·M-L SchröderJ Reifenrath
Feb 14, 2021·BMC Musculoskeletal Disorders·Martin Lindberg-LarsenUNKNOWN One-stage vs Two-stage Collaboration Group
Oct 2, 2021·Archives of Orthopaedic and Trauma Surgery·Annemarie L GoudBart C H van der Wal

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Methods Mentioned

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amputation

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