Condition category
Surgery
Date applied
28/01/2015
Date assigned
29/01/2015
Last edited
27/09/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hip replacement surgery is common, with over 86,000 cases in England and Wales in 2012. After surgery about 1% patients develop a deep infection in their artificial hip, called a prosthetic joint infection (PJI). If left untreated PJI can result in severe pain, disability and death. When an infection is found, there are two types of surgical treatment: a 1-stage revision involves removing the joint, thoroughly cleaning the infected area and implanting a new joint immediately; a 2-stage revision involves removing the joint, and delaying re-implantation for 3 to 6 months whilst treating with antibiotics. Both treatments are widely used but we don’t know which has the best long-term outcomes for patients. The aim of this study is to find out whether there is any difference in patient-reported outcomes (pain, stiffness or physical function) after 1-stage or 2-stage revision hip surgery for PJI.

Who can participate?
Patients that have a prosthetic joint infection that needs surgery.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 have 1-stage revision surgery. Those in group 2 have 2-stage revision surgery. All participants are then followed up for the next 18 months. They are asked to complete questionnaires every 3 months, to assess their hip pain and function, quality of life and any costs incurred during their treatment. They attend two appointments with a research nurse to complete questionnaires and a walk test. A small number of participants and surgeons are also interviewed about their experiences of treatment and participation in the trial. Participants who decide against the randomised trial are asked to join a monitoring group. This group have treatment-as-usual, and then complete questionnaires at home. The monitoring group provide important information on the wider population of patients with hip PJI, including patient reported outcomes, control of infection and adverse events.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
14 hospitals in the UK and 3 in Sweden (UK)

When is the study starting and how long is it expected to run for?
January 2015 to February 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mr Simon Strange

Trial website

Contact information

Type

Scientific

Primary contact

Mr Simon Strange

ORCID ID

Contact details

INFORM Programme Manager
Musculoskeletal Research Unit
Level 1
Learning and Research
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 (0)117 414 7867
simon.strange@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18159

Study information

Scientific title

A multicentre randomised trial to compare 1-stage with 2-stage revision surgery for prosthetic hip joint infection

Acronym

Study hypothesis

The aim of this study is to determine if there is any difference in patient-reported outcomes (pain, stiffness or physical function) after 1-stage or 2-stage revision hip surgery for prosthetic joint infection (PJI).

Ethics approval

NRES Committee South-West - Frenchay, 31/12/2014, ref: 14/SW/1166

Study design

Randomised; Interventional and Observational; Design type: Not specified, Treatment, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Topic: Surgery; Subtopic: Surgery; Disease: All Surgery

Intervention

Revision hip surgery
1-stage or 2-stage revision for infected prosthetic hip joint; Follow Up Length: 18 month(s)

Intervention type

Other

Phase

Drug names

Primary outcome measure

Patient-reported hip pain, stiffness, function; Timepoint(s): WOMAC at 18 months post-randomisation

Secondary outcome measures

1. Quality of life, measured using Euroquol EQ-5D-5L and HOOS
2. All hip-related complications (including continuing and reinfection) recorded throughout study period
3. Post-op pain, measured using the Brief Pain Inventory
4. Patient-reported hip function, measured using the Oxford Hip Score
5. Objective measure of hip function, measured using the 20 metre timed walk test
6. Depression and anxiety, measured using the Hospital Anxiety and Depression Score
7. Cost-effectiveness of interventions, measured using health resource use

Overall trial start date

10/02/2014

Overall trial end date

28/02/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 18 or above
2. A clinical diagnosis of prosthetic hip joint infection
3. Require revision surgery (either 1-stage or 2-stage) to treat prosthetic hip joint infection, in the opinion of the treating consultant orthopaedic surgeon
Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 228; UK Sample Size: 228; Description: RCT - 142 patients; Monitoring group - approx 80 participants

Participant exclusion criteria

1. Unable or unwilling to undergo either 1-stage or 2-stage revision surgery
2. Lack capacity to give written informed consent

Recruitment start date

19/01/2015

Recruitment end date

31/08/2018

Locations

Countries of recruitment

Sweden, United Kingdom

Trial participating centre

North Bristol NHS Trust
Trust Headquarters Beckspool Road Frenchay
Bristol
B16 1JE
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust

Sponsor details

Research & Innovation
Floor 3 Learning & Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Protocol paper
2. Trial results paper
3. Cost-effectiveness analysis paper
4. Dissemination of Best Practice Guidance

IPD sharing statement
Participant level data will be made available at the data.bris (University of Bristol Research Data repository) beginning 1 year following publication of the trial results. Access to data will ‘controlled’ and request forms can be found at http://www.bristol.ac.uk/staff/researchers/data/accessing-research-data/

Intention to publish date

09/05/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26883420

Publication citations

Additional files

Editorial Notes

27/09/2018: IPD sharing statement added. 23/07/2018: The following changes were made to the trial record: 1. The recruitment end date was changed from 31/05/2018 to 31/08/2018. 2. The overall trial end date was changed from 30/11/2019 to 28/02/2020. 3. The intention to publish date was changed from 09/02/2020 to 09/05/2020. 4. Sweden was added to the countries of recruitment. 5. The RCT recruitment target was changed from 148 to 142. 06/07/2017: The following changes were made to the trial record: 1. The overall trial start date was changed from 19/01/2015 to 10/02/2014. 2. The overall trial end date was changed from 19/01/2017 to 30/11/2019. 3. The recruitment end date was changed from 19/01/2017 to 31/05/2018. 4. The intention to publish date was changed from 01/12/2018 to 09/02/2020. 18/02/2016: Publication reference added.