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
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 prevent...
Saved in:
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2020-09-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e040985.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1841554376386150400 |
|---|---|
| author | Jonas Ranstam Jörg Schilcher Ewa Roos Jonathan Brandt Håkan Ledin Per Aspenberg |
| author_facet | Jonas Ranstam Jörg Schilcher Ewa Roos Jonathan Brandt Håkan Ledin Per Aspenberg |
| author_sort | Jonas Ranstam |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-28527a10429c4ceeade2218725a51b87 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-28527a10429c4ceeade2218725a51b872025-01-08T13:55:09ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-040985Single postoperative infusion of zoledronic acid to improve patient-reported outcome after hip or knee replacement: study protocol for a randomised, controlled, double-blinded clinical trialJonas Ranstam0Jörg Schilcher1Ewa Roos2Jonathan Brandt3Håkan Ledin4Per Aspenberg5Department of Clinical sciences, Lund University, Lund, Sweden1 Department of Orthopaedics and Department of Biomedical and Clinical Sciences, Faculty of Health Science, Linköping University Hospital, Linkoping, SwedenResearch Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, DenmarkDepartment of Orthopaedic Surgery, Capio Specialistvård Motala, Motala, SwedenDepartment of Orthopaedic Surgery, Capio Specialistvård Motala, Motala, Swedenprofessor of orthopaedics, Linköping University, SwedenIntroduction 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.https://bmjopen.bmj.com/content/10/9/e040985.full |
| spellingShingle | Jonas Ranstam Jörg Schilcher Ewa Roos Jonathan Brandt Håkan Ledin Per Aspenberg 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 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 | https://bmjopen.bmj.com/content/10/9/e040985.full |
| work_keys_str_mv | AT jonasranstam singlepostoperativeinfusionofzoledronicacidtoimprovepatientreportedoutcomeafterhiporkneereplacementstudyprotocolforarandomisedcontrolleddoubleblindedclinicaltrial AT jorgschilcher singlepostoperativeinfusionofzoledronicacidtoimprovepatientreportedoutcomeafterhiporkneereplacementstudyprotocolforarandomisedcontrolleddoubleblindedclinicaltrial AT ewaroos singlepostoperativeinfusionofzoledronicacidtoimprovepatientreportedoutcomeafterhiporkneereplacementstudyprotocolforarandomisedcontrolleddoubleblindedclinicaltrial AT jonathanbrandt singlepostoperativeinfusionofzoledronicacidtoimprovepatientreportedoutcomeafterhiporkneereplacementstudyprotocolforarandomisedcontrolleddoubleblindedclinicaltrial AT hakanledin singlepostoperativeinfusionofzoledronicacidtoimprovepatientreportedoutcomeafterhiporkneereplacementstudyprotocolforarandomisedcontrolleddoubleblindedclinicaltrial AT peraspenberg singlepostoperativeinfusionofzoledronicacidtoimprovepatientreportedoutcomeafterhiporkneereplacementstudyprotocolforarandomisedcontrolleddoubleblindedclinicaltrial |