Single postoperative infusion of zoledronic acid to improve patient-reported outcome after hip or knee replacement : study protocol for a randomised, controlled, double-blinded clinical trial
(2020) In BMJ Open 10(9).- Abstract
INTRODUCTION: In Sweden, roughly 3000 patients are reoperated each year due to pain and loss of function related to a loosened hip or knee prosthesis. These reoperations are strenuous for the patient, technically demanding and costly for the healthcare system. Any such reoperation that can be prevented would be of great benefit. Bisphosphonates are drugs that inhibit osteoclast function. Several clinical trials suggest that bisphosphonates lead to improved implant fixation and one small study even indicates better functional outcome. Furthermore, in epidemiological studies, bisphosphonates have been shown to decrease the rate of revision for aseptic loosening by half. Thus, there are several indirect indications that bisphosphonates... (More)
INTRODUCTION: In Sweden, roughly 3000 patients are reoperated each year due to pain and loss of function related to a loosened hip or knee prosthesis. These reoperations are strenuous for the patient, technically demanding and costly for the healthcare system. Any such reoperation that can be prevented would be of great benefit. Bisphosphonates are drugs that inhibit osteoclast function. Several clinical trials suggest that bisphosphonates lead to improved implant fixation and one small study even indicates better functional outcome. Furthermore, in epidemiological studies, bisphosphonates have been shown to decrease the rate of revision for aseptic loosening by half. Thus, there are several indirect indications that bisphosphonates could improve patient-reported outcome, but no firm evidence. METHODS AND ANALYSIS: This is a pragmatic randomised, placebo-controlled, double-blinded, academic clinical trial of a single postoperative dose of zoledronic acid, in patients younger than 80 years undergoing primary total hip or knee replacement for osteoarthritis. Participants will be recruited from two orthopaedic departments. All surgeries will be performed, and study drugs given at Motala Hospital, Sweden. The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up. Secondary outcomes will be investigated at 1 year, 3 years and 6 years, and stratified for hip and knee implants. These secondary endpoints are supportive, exploratory or explanatory. A total of 1000 patients will be included in the study. ETHICS AND DISSEMINATION: The study has been approved by the Regional Ethical Review Board in Linköping (DNR 2015/286-31). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for pharmacological trials. The results will be submitted for publication in peer-reviewed academic journals and disseminated to patient organisations and the media. TRIAL REGISTRATION NUMBER: EudraCT: No 2015-001200-55; Pre-results.
(Less)
- author
- Brandt, Jonathan ; Ledin, Håkan ; Ranstam, Jonas LU ; Roos, Ewa LU ; Aspenberg, Per LU and Schilcher, Jörg
- organization
- publishing date
- 2020-09-30
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- adult orthopaedics, hip, knee
- in
- BMJ Open
- volume
- 10
- issue
- 9
- article number
- e040985
- publisher
- BMJ Publishing Group
- external identifiers
-
- scopus:85092506410
- pmid:32998932
- ISSN
- 2044-6055
- DOI
- 10.1136/bmjopen-2020-040985
- language
- English
- LU publication?
- yes
- id
- 4f3db9bc-9599-4dd3-b831-530a3da7b215
- date added to LUP
- 2021-01-25 15:31:38
- date last changed
- 2024-04-04 00:49:39
@article{4f3db9bc-9599-4dd3-b831-530a3da7b215,
abstract = {{<p>INTRODUCTION: In Sweden, roughly 3000 patients are reoperated each year due to pain and loss of function related to a loosened hip or knee prosthesis. These reoperations are strenuous for the patient, technically demanding and costly for the healthcare system. Any such reoperation that can be prevented would be of great benefit. Bisphosphonates are drugs that inhibit osteoclast function. Several clinical trials suggest that bisphosphonates lead to improved implant fixation and one small study even indicates better functional outcome. Furthermore, in epidemiological studies, bisphosphonates have been shown to decrease the rate of revision for aseptic loosening by half. Thus, there are several indirect indications that bisphosphonates could improve patient-reported outcome, but no firm evidence. METHODS AND ANALYSIS: This is a pragmatic randomised, placebo-controlled, double-blinded, academic clinical trial of a single postoperative dose of zoledronic acid, in patients younger than 80 years undergoing primary total hip or knee replacement for osteoarthritis. Participants will be recruited from two orthopaedic departments. All surgeries will be performed, and study drugs given at Motala Hospital, Sweden. The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up. Secondary outcomes will be investigated at 1 year, 3 years and 6 years, and stratified for hip and knee implants. These secondary endpoints are supportive, exploratory or explanatory. A total of 1000 patients will be included in the study. ETHICS AND DISSEMINATION: The study has been approved by the Regional Ethical Review Board in Linköping (DNR 2015/286-31). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for pharmacological trials. The results will be submitted for publication in peer-reviewed academic journals and disseminated to patient organisations and the media. TRIAL REGISTRATION NUMBER: EudraCT: No 2015-001200-55; Pre-results.</p>}},
author = {{Brandt, Jonathan and Ledin, Håkan and Ranstam, Jonas and Roos, Ewa and Aspenberg, Per and Schilcher, Jörg}},
issn = {{2044-6055}},
keywords = {{adult orthopaedics; hip; knee}},
language = {{eng}},
month = {{09}},
number = {{9}},
publisher = {{BMJ Publishing Group}},
series = {{BMJ Open}},
title = {{Single postoperative infusion of zoledronic acid to improve patient-reported outcome after hip or knee replacement : study protocol for a randomised, controlled, double-blinded clinical trial}},
url = {{http://dx.doi.org/10.1136/bmjopen-2020-040985}},
doi = {{10.1136/bmjopen-2020-040985}},
volume = {{10}},
year = {{2020}},
}