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| Name | Class |
|---|---|
| Hopital Charles Lemoyne | OTHER |
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Knee replacement surgery is a surgery designed to treat severe arthritis of the knee. However, as many as 20% of patients are not satisfied with the results of their surgery. To place the knee replacement in correct position, the kinematic alignment method, which tries to reproduce the patient normal anatomy, has shown promise in improving the satisfaction after knee replacement surgery. It is not known if using a robotic arm to assist in surgery is better than the traditional method when trying to recreate kinematic alignment.
The goal of this study is to learn if robotic assisted surgery is better than traditional method for knee replacement done using kinematic alignment. The main questions the study tries to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kinematic knee replacement with traditional instruments | Active Comparator | Patients will undergo kinematic aligned knee replacement done using traditional instruments and cut guides |
|
| Robotic-assisted kinematic knee replacement | Experimental | Patients will undergo kinematic aligned knee replacement done using robotic assistance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kinematic aligned total knee replacement | Procedure | Replacement of worn knee cartilage using a prosthesis. The alignment is determined according to the patient's anatomy and ligament balance. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic alignment of the knee | Long leg anteroposterior views of both legs and lateral knee radiographs will be used to measure knee alignment and position of the knee replacement hardware. The angles measured and analyzed will be:
| Pre-operative alignement and 6 months post-operative alignement. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Patient questionnaire (42 questions) evaluating knee pain, symptoms, function, recreational activities and knee-related quality of life. The questionnaire is score over 100 points, with a higher score meaning better knee function. | Pre-operative, 6 weeks, 6 months, 12 months, 24 months post-operative |
| Forgotten joint score | A 12-questions form asking patients if they forget about their joint during activities of daily living. | Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-op |
| Joint perception question | A single item question asking participants how they perceive their operated knee, from "like a native or natural joint" to "like a nonfunctional joint". | Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Pain visual analog scale | Pain rated on a 10 cm visual analog scale from "no pain" to "worst pain imaginable" | Pre-op, 6 weeks, 6, 12, 24 months |
| Subjective Assessment Numeric Evaluation Scale (SANE) |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative procedures | During surgery, the knee for additional intra-operative procedures to obtain a stable knee replacement will be noted:
| At the time of surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuel Larrivée, MD, MSc, FRCSC | Contact | 450-466-4333 | 2 | samuel.larrivee@usherbrooke.ca |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33547914 | Background | Zhang J, Ndou WS, Ng N, Gaston P, Simpson PM, Macpherson GJ, Patton JT, Clement ND. Robotic-arm assisted total knee arthroplasty is associated with improved accuracy and patient reported outcomes: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2022 Aug;30(8):2677-2695. doi: 10.1007/s00167-021-06464-4. Epub 2021 Feb 6. | |
| 32234326 |
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Anonymous individual patient data will be shared only with a direct request to the study principal investigator.
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Double-blind randomized controlled-trial
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Statistician will be blinded to the intervention
Single question evaluation scale asking the patient to rate their knee function from 0 (no function) to 100 (completely normal function)
| Pre-op, 6 weeks, 6, 12, 24 months |
| Knee range of motion | Maximum passive flexion and extension measured with goniometer | Pre, 6 weeks, 6 and 12 months post-op |
| Knee stability | Anterior drawer, posterior drawer, valgus stress, varus stress. Instability rated for each test 1 to 3 by treating surgeon. | Pre-op, 6 weeks, 6 and 12 months post-op |
| Surgical cost |
Total cost of implants and equipment used will be calculated at the end of each surgical case. |
| At the time of surgery |
| Surgical time | The time from first incision to skin closure will be noted at each surgery. | At the time of surgery |
| Intra-operative complications | The incidence of intra-operative complications will be noted:
| At the time of surgery |
| Agarwal N, To K, McDonnell S, Khan W. Clinical and Radiological Outcomes in Robotic-Assisted Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2020 Nov;35(11):3393-3409.e2. doi: 10.1016/j.arth.2020.03.005. Epub 2020 Mar 11. |
| 36403396 | Background | Van Essen J, Stevens J, Dowsey MM, Choong PF, Babazadeh S. Kinematic alignment results in clinically similar outcomes to mechanical alignment: Systematic review and meta-analysis. Knee. 2023 Jan;40:24-41. doi: 10.1016/j.knee.2022.11.001. Epub 2022 Nov 17. |
| 24986944 | Background | Dossett HG, Estrada NA, Swartz GJ, LeFevre GW, Kwasman BG. A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. Bone Joint J. 2014 Jul;96-B(7):907-13. doi: 10.1302/0301-620X.96B7.32812. |
| 37165209 | Background | Turan K, Camurcu Y, Kezer M, Uysal Y, Kizilay YO, Ucpunar H, Temiz A. A comparison of robotic-assisted and manual techniques in restricted kinematically aligned total knee arthroplasty: coronal alignment improvement with no significant clinical differences. Knee Surg Sports Traumatol Arthrosc. 2023 Nov;31(11):4673-4679. doi: 10.1007/s00167-023-07426-8. Epub 2023 May 10. |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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