Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA

NCT05530551 | Active Not Recruiting

• 1 other identifier: ProHipQ Osteoarthritis
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 36

Brief Summary

Aim: To compare the effect of one single dose versus multiple doses of prophylactic antibiotics administered within 24 hours, on the development of PJI in patients with osteoarthritis undergoing primary THA. The study is designed as a cross-over, cluster randomized, non-inferiority trial. All Danish orthopedic surgery departments performing primary THA with the majority being within inclusion criteria will be involved: Based on national quality databases, two-year cohorts of approximately 20,000 primary THAs conducted at all public and private orthopedic departments in Denmark, this includes 36 sites corresponding to a total of 39 departments.

Conditions

Osteoarthritis, Hip; Total Hip Arthroplasty; Prosthetic-joint Infection

Keywords

Antibiotic Prophylaxis; OA; Osteoarthritis; Osteoarthritis, Hip; Total Hip Replacement; Total Hip Arthroplasty; Prosthetic Joint Infection; PJI; Cluster Randomized Controlled Trial; Randomized Controlled Trial; RCT; THA

Outcome Measures

Primary Outcomes (1)

• Incidence of Prosthetic joint infections (PJI)

  The definition of PJI is based on revision surgery. Revision surgery is defined as a new surgical intervention the first time after the primary intervention including debridement alone or in combination with complete or partial removal or exchange of the implant. 1. Two or more intraoperative deep-tissue samples of phenotypically indistinguishable bacteria isolated from at least 3 deep-tissue samples 2. One or more positive intraoperative samples from a closed fluid aspirate AND a biopsy (fluid AND tissue) of phenotypically indistinguishable bacteria isolated 3. A PJI when an indication of deep infection is reported to The Danish Hip Arthroplasty Registry (DHR) by the surgeon upon revision surgery

  Within 90 days from index surgery

Secondary Outcomes (9)

• Number of patients with one or more Serious Adverse Events (SAEs)

  Within 90 days from index surgery

• Incidence of Potential PJI referred to as PJI-likely

  Within 90 days from index surgery

• Length of hospital stay (LOS)

  Within 90 days from index surgery

• Incidence of Major Adverse Cardiovascular Events (MACE)

  Within 90 days from index surgery

• Hospital-treated infections (excluding Surgical Site infections)

  Within 90 days from index surgery

Other Outcomes (4)

• Incremental cost-effectiveness

  Within 90 days from index surgery

• Rate of revision after THA

  Within 1 year from index surgery

• Mortality rate after index surgery

  Within 1 year from index surgery

Study Arms (2)

Treatment A, Single-dose practice

EXPERIMENTAL

One preoperative single dose of either Dicloxacillin/Cloxacillin 2g OR Cefuroxime 1.5g administered intravenously prior to surgical incision. As the study is a non-inferiority trial, we have chosen the Experimental design category.

Other: Antibiotic dosage practice

Treatment B, Multiple-dose practice

ACTIVE COMPARATOR

One preoperative dose of either Dicloxacillin/Cloxacillin 2g OR Cefuroxime 1.5g administered intravenously prior to surgical incision followed by 3 postoperative doses of Dicloxacillin/Cloxacillin 1g x 3 OR Cefuroxime 750mg x 3 within 24 hours after the preoperative dose.

Other: Antibiotic dosage practice

Interventions

Antibiotic dosage practice OTHER

Patient inclusion starts day one, cross-over of departments from treatment A (single-dose) to B (multiple-dose) or vice versa after one year and end of inclusion happens after 2 years. All centers in Denmark use either Cloxacillin/Dicloxacillin, Cefuroxime or both drugs as standard prophylactic antibiotic practice for THA. In cases of cephalosporin allergy or general beta lactam allergy, the antibiotic clindamycin may be administered. In this trial, patients will be administered the standard prophylactic antibiotic practice of either single-dose (A) or multiple-doses (B) of antibiotics administered at each respective cluster that respective year. Both practices of dose administration for antibiotic prophylaxis (i.e. single- or multiple-dose) follow current standards of treatment and are based on present clinical practice guidelines.

Treatment A, Single-dose practice; Treatment B, Multiple-dose practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All patients receiving a primary Total Hip Arthroplasty (THA) due to primary and secondary causes of osteoarthritis

You may not qualify if:

• Patients receiving a primary THA due to either acute or sequelae of proximal femoral or acetabular fractures
• Patients receiving a primary THA due to bone tumor or metastasis

Sponsors & Collaborators

• Soren Overgaard: lead
• University of Copenhagen: collaborator
• University Hospital Bispebjerg and Frederiksberg: collaborator
• Odense University Hospital: collaborator
• Aarhus University Hospital: collaborator
• University of Aarhus: collaborator
• Sygehus Lillebaelt: collaborator

Study Sites (36)

Department of Orthopedic Surgery, Hospital of Southern Jutland, Aabenraa and Sønderborg

Aabenraa, 6200/6400, Denmark

Location

Capio Private Hospital, Aalborg

Aalborg, 9000, Denmark

Location

Department of Orthopedic Surgery, Aalborg, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Aleris Private Hospital, Aarhus

Aarhus, 8200, Denmark

Location

Deaprtment of Orthopaedic Surgery, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Capio Private Hospital, Aarhus

Aarhus C, 8000, Denmark

Location

Capio Private Hospital, Gildhøj

Brøndby, 2605, Denmark

Location

Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital - Bispebjerg and Frederiksberg

Copenhagen NV, 2400, Denmark

Location

Adeas Private Hospital, Parken

Copenhagen Ø, 2100, Denmark

Location

Department of Orthopedic Surgery, Esbjerg, Hospital of South West Jutland

Esbjerg, 6700, Denmark

Location

Department of Orthopedic Surgery, Farsø, Aalborg University Hospital

Farsø, 9640, Denmark

Location

CPH Private Hospital

Farum, 3520, Denmark

Location

Department of Orthopedic Surgery, Frederikshavn, Aalborg University Hospital

Frederikshavn, 9900, Denmark

Location

Department of Orthopedic Surgery, Grindsted, Hospital of South West Jutland

Grindsted, 7200, Denmark

Location

Capio Private Hospital, Hellerup and Odense

Hellerup, 2900/5000, Denmark

Location

Department of Orthopaedic Surgery, Gentofte, Copenhagen University Hospital - Herlev and Gentofte

Hellerup, 2900, Denmark

Location

Department of Orthopaedic Surgery, Herlev, Copenhagen University Hospital - Herlev and Gentofte

Herlev, 2730, Denmark

Location

Department of Orthopedic Surgery, Gødstrup Regional Hospital

Herning, 7400, Denmark

Location

Department of Orthopedic Surgery, Hillerød, Copenhagen University Hospital - North Zealand

Hillerød, 3400, Denmark

Location

Department of Orthopedic Surgery, Copenhagen University Hospital - Holbæk

Holbæk, 4300, Denmark

Location

Department of Orthopedic Surgery, Horsens Regional Hospital, Denmark

Horsens, 8700, Denmark

Location

Department of Orthopedic Surgery, Hvidovre, Copenhagen University Hospital - Amager and Hvidovre

Hvidovre, 2650, Denmark

Location

Acure Private Hospital

Kongens Lyngby, 2800, Denmark

Location

Kollund Private Hospital, Kollund

Kruså, 6340, Denmark

Location

Department of Orthopedic Surgery, Zealand University Hospital, Køge

Køge, 4600, Denmark

Location

Department of Orthopedic Surgery, Copenahegn University Hospital - Nykøbing F

Nykøbing Falster, 4800, Denmark

Location

Department for Planned Orthopaedic Surgery, Næstved, Copenhagen University Hospital - Næstved, Slagelse and Ringsted

Næstved, 4700, Denmark

Location

Department of Orthopedic Surgery and Traumatology, Odense University Hospital and Svendborg Hospital

Odense, 5000/5700, Denmark

Location

Deparmtent of Orthopedic Surgery, Randers Regional Hospital

Randers, 8930, Denmark

Location

Aleris Private Hospital, Ringsted

Ringsted, 4100, Denmark

Location

Department of Surgery, Copenhagen University Hospital - Bornholm

Rønne, 3700, Denmark

Location

Center for Planned Surgery, Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

Aleris Private Hospital, Søborg

Søborg, 2860, Denmark

Location

Department of Orthopedics, Lillebaelt Hospital, Vejle

Vejle, 7100, Denmark

Location

Mølholm Private Hospital, Vejle

Vejle, 7100, Denmark

Location

Deparmtent of Orthopedic Sugery, Viborg Regional Hospital

Viborg, 8800, Denmark

Location

Related Publications (1)

• Abedi AA, Varnum C, Pedersen AB, Gromov K, Hallas J, Iversen P, Jakobsen T, Jimenez-Solem E, Kidholm K, Kjerulf A, Lange J, Odgaard A, Rosenvinge FS, Solgaard S, Sperling K, Stegger M, Christensen R, Overgaard S. Effect of single versus multiple prophylactic antibiotic doses on prosthetic joint infections following primary total hip arthroplasty in patients with osteoarthritis at public and private hospitals in Denmark: protocol for a nationwide cross-over, cluster randomised, non-inferiority trial [The Pro-Hip-Quality Trial]. BMJ Open. 2023 Aug 21;13(8):e071487. doi: 10.1136/bmjopen-2022-071487.

  PMID: 37604637 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Armita A Abedi, MD

  Copenhagen University Hospital Bispebjerg, Department of Orthopaedic Surgery and Traumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding will not be applicable, because it is considered infeasible to expose participants and clinical personnel to this in either of the groups since any specific clinic will follow their allocated specific (single- or multiple-dose) routine during an entire 1-year period and their routine treatment of any complication (before switching).
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor, DMSc

Model Details: The Pro-Hip-Quality Trial is a Cluster Randomized Trial with an embedded Cross-Over Design where each clinical center (C: 1, 2, 3, …., 36 individual sites) will be running a specific intervention (i.e. single- or multiple-dose antibiotics) throughout 12 months, and the subsequent year the clinical department will automatically switch to the opposite intervention (i.e. multiple- or single-dose antibiotics).

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 7, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication, no end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

DK (36)