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

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ClinicalTrials.gov Identifier: NCT04135170
Recruitment Status : Not yet recruiting
First Posted : October 22, 2019
Last Update Posted : June 1, 2020
Sponsor:
Collaborator:
Helse Vest
Information provided by (Responsible Party):
Asst. professor Tesfaye Hordofa Leta (Nurse, Postdoc fellow), The Norwegian Arthroplasty Register

Brief 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 single-blinded 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 11,008 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


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Combination Product: ALBC vs plain bone cement Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11008 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients undergoing full-cemented primary TKA in any Norwegian hospitals are eligible for participation irrespectively of the diagnosis leading to TKA. and randomly assigned to receive ALBC (control group) or plain bone cement (experimental group).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: This is a double blinded, non-inferiority register-based multicenter randomized controlled trial study. To ensure blinding of the patients, all patients are operated by the same surgical method and the type of cement is unknown to the patients. In this study, blinding of the surgeon is not possible because the surgeon recognizes the cement type and has to document the type of cement in the registration form. We believe the primary endpoint of this trial is not likely to be influenced by the surgeon knowledge of the cement used in the index surgery. The data analyst will be blinded for groups until the entire trial analysis has been completed to minimize the risk of bias that may be introduced during the statistical analysis because of the selective use and reporting of statistical tests.
Primary Purpose: Prevention
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)
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Plain bone cement 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.

Active Comparator: Antibiotic loaded bone cement 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.




Primary Outcome Measures :
  1. risk of revision due to PJI [ Time Frame: 1-year follow-up ]

Secondary Outcome Measures :
  1. risk of revision due to any reason including aseptic loosening [ Time Frame: 1-, 6-, 10-, and 20-years follow-up ]
  2. risk of changes in the microbial pattern and resistance profiles of organisms cultured in subsequent revisions [ Time Frame: 1-, 6-, 10-, and 20-years follow-up ]
  3. Change in mean scores from baseline function (in activity of daily life) on the Knee injury and Osteoarthritis Outcome Score (KOOS). [ Time Frame: 1-, 6-, and 10-years follow-up ]
  4. 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. [ Time Frame: 1-, 6-, and 10-years follow-up ]
  5. Change in mean scores from baseline in EQ-5D-5L for health related quality of life(HRQoL). [ Time Frame: 1-, 6-, and 10-years follow-up ]
  6. 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. [ Time Frame: 1-, 6-, and 10-years follow-up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135170


Contacts
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Contact: Tesfaye H Leta, PhD +4791691925 tesfaye.hordofa.leta@helse-bergen.no
Contact: Ove Furnes, MD/PhD +4790840088 ove.nord.furnes@helse-bergen.no

Sponsors and Collaborators
The Norwegian Arthroplasty Register
Helse Vest
Investigators
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Study Chair: Ove Furnes, MD/PhD The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital
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Responsible Party: Asst. professor Tesfaye Hordofa Leta (Nurse, Postdoc fellow), Associate professor/ postdoc fellowship, The Norwegian Arthroplasty Register
ClinicalTrials.gov Identifier: NCT04135170    
Other Study ID Numbers: NorwegianArthroplastyRegister
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asst. professor Tesfaye Hordofa Leta (Nurse, Postdoc fellow), The Norwegian Arthroplasty Register:
Register based randomized control trial
Non-inferiority
Total knee arthroplasty
Antibiotic loaded bone cement
Plain bone cement
Antibiotic resistance bacteria
Periprosthetic joint infection
Patient reported outcome measure
Health related quality of life
Pain
Function
Satisfaction
Revision surgery
Primary surgery
Additional relevant MeSH terms:
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Infection
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases