Antibiotic Loaded Bone Cement in Prevention of Periprosthetic Joint Infections in Primary Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

— ALBA  

Official title:

Antibiotic Loaded Bone Cement in Prevention of Periprosthetic Joint Infections in Primary Total Knee Arthroplasty: A Register-based Multicenter Randomized Controlled Non-inferiority Trial (Acronym: ALBA Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04135170
• Other study ID #: NorwegianArthroplastyRegister
• Status: Recruiting
• Phase: Phase 2
• Start date: January 14, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2021
• Source: The Norwegian Arthroplasty Register
• Contact: Tesfaye H Leta, PhD
• Phone: +4791691925
• Email: tesfaye.hordofa.leta[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: The current evidence on the efficacy of Antibiotic Loaded Bone Cement (ALBC) in reducing the risk of periprosthetic joint infections (PJI) after primary joint reconstruction is insufficient. In several European countries, the use of ALBC is routine practice unlike in the US where ALBC use is not approved in low-risk patients. It has been claimed that the antibiotic in ALBC increase the risk of aseptic loosening, risk of systemic toxicity, allergic reaction, and bacterial resistance. Therefore we designed a double-blinded (patients and data analysts) pragmatic multicenter register-based randomized controlled non-inferiority trial to investigate the effects of ALBC compared to plain bone cement in primary total knee arthroplasty (TKA).

Methods and analysis: A minimum of 9,172 patients undergoing full-cemented primary TKA will be recruited and equally randomized into the ALBC group and the plain bone cement group. This trial will be conducted in Norwegian hospitals that routinely perform cemented primary TKA. . The primary outcome will be risk of revision surgery due to PJI at 1-year of follow-up. Secondary outcomes will be:

• risk of revision due to any reason including aseptic loosening at 1-, 6-, 10-, and 20-years of follow-up;

• patient related outcome measures (PROMs) like function, pain, satisfaction, and health-related quality of life at 1-, 6-, and 10-years of follow-up;

• risk of changes in the microbial pattern and resistance profiles of organisms cultured in subsequent revisions at 1-, 6-, 10-, and 20-years of follow-up; and

• cost-effectiveness of routine ALBC vs plain bone cement use in primary TKA. We will use 1:1 randomization with random permuted blocks and stratify by participating hospitals to randomize patients to receive ALBC or plain bone cement. Inclusion, randomization, and follow-up will be through the Norwegian Arthroplasty Register.

Ethics and dissemination: The trial has been approved by the Western Norway Regional Committees on Medical and Health Research Ethics (REK-Vest) (reference number: 2019/751/REK vest) dated: 21.06.2019. The trial results will be reported following the Consolidated Standards of Reporting Trials Extension (CONSORT Extension) reporting guideline 2010 statement for non-inferiority trials. The trial results will be reported to the public through national and international scientific conferences, participating hospitals, patient organizations, and peer-reviewed journals.

Discussion: If we find that plain bone cement is non-inferior to the ALBC, it will challenge the routine use of ALBC in primary arthroplasty, due to ecological concerns and costs. However, if routine use of ALBC is associated with a reduced risk of PJI and with minor impact on bacterial resistance, PROMs, and costs, the well-established use of prophylactic ALBC in primary arthroplasty will be supported

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9172
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients undergoing full-cemented primary TKA irrespective of the diagnosis leading to TKA

Exclusion Criteria:

• any history of infection in the knee, a need for fully stabilized or hinged TKA, a history of allergy to the antibiotics used in the cement, inability or not willing to consent for inclusion in NAR or the trial, and participation in other studies that might have pharmacological interaction with this trial.

Related Conditions & MeSH terms

• Infection
• Osteoarthritis, Knee

Intervention

Combination Product:
• ALBC vs plain bone cement
The patients undergoing full-cemented primary total knee arthroplasty are allocated to either ALBC or plain bone cement and compare the effectiveness of ALBC use vs pain bone cement bone cement without antibiotic) with respect to revision due to PJI one year after primary TKA surgery.

Locations

Country	Name	City	State
Norway	Department of Orthopeadic Surgery, Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
The Norwegian Arthroplasty Register	Helse Vest

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	risk of revision due to PJI		1-year follow-up
Secondary	risk of revision due to any reason including aseptic loosening		1-, 6-, 10-, and 20-years follow-up
Secondary	risk of changes in the microbial pattern and resistance profiles of organisms cultured in subsequent revisions		1-, 6-, 10-, and 20-years follow-up
Secondary	Change in mean scores from baseline function (in activity of daily life) on the Knee injury and Osteoarthritis Outcome Score (KOOS).		1-, 6-, and 10-years follow-up
Secondary	Change in mean scores from baselinein in Visual Analog Sale (the scores range from 0 to 100, with 0 indicating the worst possible state and 100 indicating the best possible state) for pain.		1-, 6-, and 10-years follow-up
Secondary	Change in mean scores from baseline in EQ-5D-5L for health related quality of life(HRQoL).		1-, 6-, and 10-years follow-up
Secondary	Mean scores in Visual Analog Sale ( the scores range from 0 to 100, with 0 indicating the worst possible state and 100 indicating the best possible state) for patient satisfaction.		1-, 6-, and 10-years follow-up