Dataset Information

Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial.

ABSTRACT:

Objectives

To determine whether patient reported outcomes improve after single stage versus two stage revision surgery for prosthetic joint infection of the hip, and to determine the cost effectiveness of these procedures.

Design

Pragmatic, parallel group, open label, randomised controlled trial.

Setting

High volume tertiary referral centres or orthopaedic units in the UK (n=12) and in Sweden (n=3), recruiting from 1 March 2015 to 19 December 2018.

Participants

140 adults (aged ≥18 years) with a prosthetic joint infection of the hip who required revision (65 randomly assigned to single stage and 75 to two stage revision).

Interventions

A computer generated 1:1 randomisation list stratified by hospital was used to allocate participants with prosthetic joint infection of the hip to a single stage or a two stage revision procedure.

Main outcome measures

The primary intention-to-treat outcome was pain, stiffness, and functional limitations 18 months after randomisation, measured by the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes included surgical complications and joint infection. The economic evaluation (only assessed in UK participants) compared quality adjusted life years and costs between the randomised groups.

Results

The mean age of participants was 71 years (standard deviation 9) and 51 (36%) were women. WOMAC scores did not differ between groups at 18 months (mean difference 0.13 (95% confidence interval -8.20 to 8.46), P=0.98); however, the single stage procedure was better at three months (11.53 (3.89 to 19.17), P=0.003), but not from six months onwards. Intraoperative events occurred in five (8%) participants in the single stage group and 20 (27%) in the two stage group (P=0.01). At 18 months, nine (14%) participants in the single stage group and eight (11%) in the two stage group had at least one marker of possible ongoing infection (P=0.62). From the perspective of healthcare providers and personal social services, single stage revision was cost effective with an incremental net monetary benefit of £11 167 (95% confidence interval £638 to £21 696) at a £20 000 per quality adjusted life years threshold (£1.0; $1.1; €1.4).

Conclusions

At 18 months, single stage revision compared with two stage revision for prosthetic joint infection of the hip showed no superiority by patient reported outcome. Single stage revision had a better outcome at three months, fewer intraoperative complications, and was cost effective. Patients prefer early restoration of function, therefore, when deciding treatment, surgeons should consider patient preferences and the cost effectiveness of single stage surgery.

Trial registration

ISRCTN registry ISRCTN10956306.

SUBMITTER: Blom AW

PROVIDER: S-EPMC9645409 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial.

Blom Ashley W AW Lenguerrand Erik E Strange Simon S Noble Sian M SM Beswick Andrew D AD Burston Amanda A Garfield Kirsty K Gooberman-Hill Rachael R Harris Shaun R S SRS Kunutsor Setor K SK Lane J Athene JA MacGowan Alasdair A Mehendale Sanchit S Moore Andrew J AJ Rolfson Ola O Webb Jason C J JCJ Wilson Matthew M Whitehouse Michael R MR

BMJ (Clinical research ed.) 20221031

<h4>Objectives</h4>To determine whether patient reported outcomes improve after single stage versus two stage revision surgery for prosthetic joint infection of the hip, and to determine the cost effectiveness of these procedures.<h4>Design</h4>Pragmatic, parallel group, open label, randomised controlled trial.<h4>Setting</h4>High volume tertiary referral centres or orthopaedic units in the UK (n=12) and in Sweden (n=3), recruiting from 1 March 2015 to 19 December 2018.<h4>Participants</h4>140 a ...[more]

PMID: 36316046

Similar Datasets

Project description:Deep prosthetic hip infection is a devastating complication of hip replacement surgery, and treatment often involves multiple revision surgeries with antibiotic chemotherapy to control the infection. The aim of this study was to explore patients' experiences of early and longer-term recovery after one-stage or two-stage revision with an excised hip, a temporary cement spacer or a custom-made articulating spacer. We interviewed 32 participants taking part in a surgical trial at two time points (2-4 months and 18 months) following one- or two-stage revision surgery. The analytic approach was inductive using the constant comparative method to generate themes from the data. Participants' early recovery after revision was characterised by a long hospital stay with burdensome antibiotics and limited physiotherapy provision. Participants undergoing two-stage revision with an excised hip or a cement spacer described severe mobility restrictions which affected all aspects of their lives, while those undergoing one-stage revision, or two-stage revision with an articulating spacer were more mobile and independent, with some limitations. Participants with a cement spacer also reported more pain than other treatment groups, while those with an articulating spacer appeared to perceive that their recovery was slow. At 18 months, participants in all groups described both improvements and losses in mobility and functional ability. Participants in all treatment groups expressed considerable emotional resilience during recovery from revision, which may be linked to opportunities to talk with the trial personnel. Participants identified the need for better information and psychological and physical support. Experience of recovery differs after one- and two-stage revision, and further in relation to the use of spacers. Mobility, function, independence and pain are important aspects of recovery which affect all aspects of day-to-day life. Increased information and more opportunities to talk and share experiences may provide psychological support during recovery.

Project description:Background Two-stage revision arthroplasty is the gold standard for treating chronic prosthetic joint infection (PJI), but there has been limited analysis of the costs incurred beyond the index procedure and how additional complications and/or surgeries impact the cost of care. Methods The electronic health record was queried for patients who underwent a total hip arthroplasty complicated by PJI and then underwent removal of the prosthesis with implantation of an antibiotic-impregnated articulating cement spacer. Patient demographics, surgical variables, hospital readmissions, emergency department (ED) visits, and postoperative complications were recorded. Data on total costs were collected with an internal accounting database. The average follow-up duration was 3.35 years. Results Univariate analyses showed statistically significant differences between outcome groups (reimplantation, reimplantation requiring later revision, retained spacer, and Girdlestone resection arthroplasty) in total overall costs, ED visit costs, and postoperative costs at 1 and 2 years after the initial spacer placement. The median total cost at 2 years for each group was $38,865 ($29,144-49,471) (reimplantation), $79,223 ($53,442-100,152) (reimplantation with revision), $54,096 ($20,872-73,903) (retained spacer), $62,134 ($52,135-101,546) (Girdlestone). Patients who underwent successful reimplantation requiring no further surgery had significantly lower total costs than patients who needed revision surgeries after reimplantation ($38,865 [$29,144-49,471] vs $79,223 [$53,442-100,152], P = .007). Patients with a Girdlestone resection arthroplasty had higher total costs at 1 year ($59,708 [$41,781-80,916] vs $33,093 [$27,237-40,429], P = .043) and higher costs attributable to ED visits at 2 years than the reimplantation group ($23,581 [$14,029-41,519] vs $15,307 [$6291-29,119], P = .009). Conclusions A significant variation exists among total costs for the 2-stage treatment of hip PJI when stratified by the final outcome.

Dataset Information

Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial.

Objectives

Design

Setting

Participants

Interventions

Main outcome measures

Results

Conclusions

Trial registration

Publications

Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial.

Similar Datasets

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