Image-based robotic (ROSA® knee system) total knee arthroplasty with inverse kinematic alignment compared to conventional total knee arthroplasty
Abstract Introduction In 2020, 368 million people globally were affected by knee osteoarthritis, and prevalence is projected to increase with 74% by 2050. Relatively high rates of dissatisfactory results after total knee arthroplasty (TKA), as reported by approximately 20% of patients, may be caused...
Saved in:
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-01-01
|
| Series: | Journal of Orthopaedic Surgery and Research |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13018-024-05427-y |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832594530041331712 |
|---|---|
| author | Henriëtte M. Eijking Isobel M. Dorling Emil H. van Haaren Roel Hendrickx Thijs Nijenhuis Martijn G.M. Schotanus Lee Bouwman Jasper Most Bert Boonen |
| author_facet | Henriëtte M. Eijking Isobel M. Dorling Emil H. van Haaren Roel Hendrickx Thijs Nijenhuis Martijn G.M. Schotanus Lee Bouwman Jasper Most Bert Boonen |
| author_sort | Henriëtte M. Eijking |
| collection | DOAJ |
| description | Abstract Introduction In 2020, 368 million people globally were affected by knee osteoarthritis, and prevalence is projected to increase with 74% by 2050. Relatively high rates of dissatisfactory results after total knee arthroplasty (TKA), as reported by approximately 20% of patients, may be caused by sub-optimal knee alignment and balancing. While mechanical alignment has traditionally been the goal, patient-specific alignment strategies are gaining interest. Robotic assistance could potentially facilitate implementation of these alignment strategies through data-based surgical planning, accurate execution of the surgical plan and validation. The clinical value of surgical assistance in diverging from mechanical alignment remains to be investigated. In the present study, robotic-assisted TKA will be performed to pursue inverse kinematic alignment (iKA) within predefined boundaries, focusing on restoring native tibia joint line. Methods This randomized controlled trial evaluates clinical effectiveness of robotic-assisted TKA (ROSA® Knee System, Zimmer Biomet, Montreal, Quebec, Canada) aiming for iKA compared to conventional TKA aiming for mechanical alignment. A total of 150 participants will be randomized (1:1) to either treatment to provide an 80% power for a 4.8-point clinically important difference in the primary outcome measure, the Oxford Knee Score (OKS) 12 months after surgery. Allocation was achieved using computer-based randomization. Outcomes will be analyzed using linear mixed models with time and group as main factors and interaction-term. Secondary outcomes include clinical metrics (leg alignment, implant and patient survival), surgical parameters (adverse events, surgery duration, blood loss, hospital stay length, medication use), patient-reported outcomes (symptoms, quality of life, pain), mobility and physical activity measurements, metabolic syndrome, cost-efficacy, and gait and continuous glucose monitoring. Ethics and dissemination This study has been approved by the Medical Ethical Committee Zuyd and Zuyderland Medical Centre (NL79161.096.21/METCZ20220006), September 2022. Trial registration number NCT05685693 (clinicaltrials.gov). |
| format | Article |
| id | doaj-art-161bc901d2fe46748683ce468636f5fa |
| institution | Kabale University |
| issn | 1749-799X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Orthopaedic Surgery and Research |
| spelling | doaj-art-161bc901d2fe46748683ce468636f5fa2025-01-19T12:32:41ZengBMCJournal of Orthopaedic Surgery and Research1749-799X2025-01-0120111110.1186/s13018-024-05427-yImage-based robotic (ROSA® knee system) total knee arthroplasty with inverse kinematic alignment compared to conventional total knee arthroplastyHenriëtte M. Eijking0Isobel M. Dorling1Emil H. van Haaren2Roel Hendrickx3Thijs Nijenhuis4Martijn G.M. Schotanus5Lee Bouwman6Jasper Most7Bert Boonen8Excellence Center for Hip & Knee Arthroplasty, Department of Orthopedic Surgery, Zuyderland Medical CenterExcellence Center for Hip & Knee Arthroplasty, Department of Orthopedic Surgery, Zuyderland Medical CenterExcellence Center for Hip & Knee Arthroplasty, Department of Orthopedic Surgery, Zuyderland Medical CenterExcellence Center for Hip & Knee Arthroplasty, Department of Orthopedic Surgery, Zuyderland Medical CenterExcellence Center for Hip & Knee Arthroplasty, Department of Orthopedic Surgery, Zuyderland Medical CenterExcellence Center for Hip & Knee Arthroplasty, Department of Orthopedic Surgery, Zuyderland Medical CenterDepartment Clinical Engineering, Faculty of Science and Engineering, Medicine and Life Sciences (FHML), Maastricht UniversityExcellence Center for Hip & Knee Arthroplasty, Department of Orthopedic Surgery, Zuyderland Medical CenterExcellence Center for Hip & Knee Arthroplasty, Department of Orthopedic Surgery, Zuyderland Medical CenterAbstract Introduction In 2020, 368 million people globally were affected by knee osteoarthritis, and prevalence is projected to increase with 74% by 2050. Relatively high rates of dissatisfactory results after total knee arthroplasty (TKA), as reported by approximately 20% of patients, may be caused by sub-optimal knee alignment and balancing. While mechanical alignment has traditionally been the goal, patient-specific alignment strategies are gaining interest. Robotic assistance could potentially facilitate implementation of these alignment strategies through data-based surgical planning, accurate execution of the surgical plan and validation. The clinical value of surgical assistance in diverging from mechanical alignment remains to be investigated. In the present study, robotic-assisted TKA will be performed to pursue inverse kinematic alignment (iKA) within predefined boundaries, focusing on restoring native tibia joint line. Methods This randomized controlled trial evaluates clinical effectiveness of robotic-assisted TKA (ROSA® Knee System, Zimmer Biomet, Montreal, Quebec, Canada) aiming for iKA compared to conventional TKA aiming for mechanical alignment. A total of 150 participants will be randomized (1:1) to either treatment to provide an 80% power for a 4.8-point clinically important difference in the primary outcome measure, the Oxford Knee Score (OKS) 12 months after surgery. Allocation was achieved using computer-based randomization. Outcomes will be analyzed using linear mixed models with time and group as main factors and interaction-term. Secondary outcomes include clinical metrics (leg alignment, implant and patient survival), surgical parameters (adverse events, surgery duration, blood loss, hospital stay length, medication use), patient-reported outcomes (symptoms, quality of life, pain), mobility and physical activity measurements, metabolic syndrome, cost-efficacy, and gait and continuous glucose monitoring. Ethics and dissemination This study has been approved by the Medical Ethical Committee Zuyd and Zuyderland Medical Centre (NL79161.096.21/METCZ20220006), September 2022. Trial registration number NCT05685693 (clinicaltrials.gov).https://doi.org/10.1186/s13018-024-05427-yRobotic surgeryKnee osteoarthritisTotal knee arthroplastyInverse kinematic alignment |
| spellingShingle | Henriëtte M. Eijking Isobel M. Dorling Emil H. van Haaren Roel Hendrickx Thijs Nijenhuis Martijn G.M. Schotanus Lee Bouwman Jasper Most Bert Boonen Image-based robotic (ROSA® knee system) total knee arthroplasty with inverse kinematic alignment compared to conventional total knee arthroplasty Journal of Orthopaedic Surgery and Research Robotic surgery Knee osteoarthritis Total knee arthroplasty Inverse kinematic alignment |
| title | Image-based robotic (ROSA® knee system) total knee arthroplasty with inverse kinematic alignment compared to conventional total knee arthroplasty |
| title_full | Image-based robotic (ROSA® knee system) total knee arthroplasty with inverse kinematic alignment compared to conventional total knee arthroplasty |
| title_fullStr | Image-based robotic (ROSA® knee system) total knee arthroplasty with inverse kinematic alignment compared to conventional total knee arthroplasty |
| title_full_unstemmed | Image-based robotic (ROSA® knee system) total knee arthroplasty with inverse kinematic alignment compared to conventional total knee arthroplasty |
| title_short | Image-based robotic (ROSA® knee system) total knee arthroplasty with inverse kinematic alignment compared to conventional total knee arthroplasty |
| title_sort | image based robotic rosa r knee system total knee arthroplasty with inverse kinematic alignment compared to conventional total knee arthroplasty |
| topic | Robotic surgery Knee osteoarthritis Total knee arthroplasty Inverse kinematic alignment |
| url | https://doi.org/10.1186/s13018-024-05427-y |
| work_keys_str_mv | AT henriettemeijking imagebasedroboticrosakneesystemtotalkneearthroplastywithinversekinematicalignmentcomparedtoconventionaltotalkneearthroplasty AT isobelmdorling imagebasedroboticrosakneesystemtotalkneearthroplastywithinversekinematicalignmentcomparedtoconventionaltotalkneearthroplasty AT emilhvanhaaren imagebasedroboticrosakneesystemtotalkneearthroplastywithinversekinematicalignmentcomparedtoconventionaltotalkneearthroplasty AT roelhendrickx imagebasedroboticrosakneesystemtotalkneearthroplastywithinversekinematicalignmentcomparedtoconventionaltotalkneearthroplasty AT thijsnijenhuis imagebasedroboticrosakneesystemtotalkneearthroplastywithinversekinematicalignmentcomparedtoconventionaltotalkneearthroplasty AT martijngmschotanus imagebasedroboticrosakneesystemtotalkneearthroplastywithinversekinematicalignmentcomparedtoconventionaltotalkneearthroplasty AT leebouwman imagebasedroboticrosakneesystemtotalkneearthroplastywithinversekinematicalignmentcomparedtoconventionaltotalkneearthroplasty AT jaspermost imagebasedroboticrosakneesystemtotalkneearthroplastywithinversekinematicalignmentcomparedtoconventionaltotalkneearthroplasty AT bertboonen imagebasedroboticrosakneesystemtotalkneearthroplastywithinversekinematicalignmentcomparedtoconventionaltotalkneearthroplasty |