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The present randomized controlled trial is designed to compare one novel total knee replacement (TKR) design and two conventional TKR designs in terms of functional outcome. 80 patients will be randomized in each of the three arms (240 altogether).
The study will compare the short-term functional outcome (at 2 years) of TKR performed with a novel TKR design (Persona , Zimmer, Warsaw, IN, USA) against TKRs performed with two conventional designs (PFC, DePuy, Warsaw, IN, USA and Nexgen, Zimmer, Warsaw, IN, USA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFC Total Knee Replacement | Active Comparator | PFC, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital. |
|
| NexGen Total Knee Replacement | Active Comparator | NexGen, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital. |
|
| Persona Total Knee Replacement | Active Comparator | Persona, Novel design Perioperative treatment will be carried out according to routine protocol of the hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NexGen | Device | Comparing two conventional designs and one novel design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in patient reported outcome measures scores (PROMs), Functional improvement | Oxford Knee Score (OKS) | preoperative, postoperative at 2-3 months, at 1 year and at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in PROMs, Functional improvement | Forgotten Joint Score (FJS) | preoperative, postoperative at 2-3 months, at 1 year and at 2 years |
| Changes in health-related quality of life (HRQoL) | 15D |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tero Irmola, MD | Coxa, Hospital for Joint Replacement | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coxa, Hospital for Joint Replacement | Tampere | Pirkanmaa | 33101 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15118039 | Background | Ethgen O, Bruyere O, Richy F, Dardennes C, Reginster JY. Health-related quality of life in total hip and total knee arthroplasty. A qualitative and systematic review of the literature. J Bone Joint Surg Am. 2004 May;86(5):963-74. doi: 10.2106/00004623-200405000-00012. | |
| 17453401 | Background | Rasanen P, Paavolainen P, Sintonen H, Koivisto AM, Blom M, Ryynanen OP, Roine RP. Effectiveness of hip or knee replacement surgery in terms of quality-adjusted life years and costs. Acta Orthop. 2007 Feb;78(1):108-15. doi: 10.1080/17453670610013501. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Patients will be recruited from Coxa outpatient clinic according to inclusion and exclusion criteria. The participating orthopedic surgeons will recruit patients along their out-patient work. The indications for the surgical treatment in the study will follow the routine clinical guidelines of the hospital. When TKR surgery is decided, the eligible patients will be informed and those willing to participate will be randomized into one of the three implant groups.
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Patients will be operated upon using the implant allocated in randomization. Participants are blinded to the implant design used for their operation. Staff at the ward is also blinded. And the physiotherapists conducting the follow-up visits (at 2-3 months, 1 year and 2 years, i.e. the outcome assessors) are also blinded to the allocation.
| Persona | Device | Comparing two conventional designs and one novel design |
|
| PFC | Device | Comparing two conventional designs and one novel design |
|
| preoperative, postoperative at 2-3 months, at 1 year and at 2 years |
| Changes in activity rating scale | UCLA activity score | preoperative, postoperative at 2-3 months, at 1 year and at 2 years |
| Changes in pain scale measurement | VAS pain scale | preoperative, postoperative at 2-3 months, at 1 year and at 2 years |
| 23307684 | Background | Jenkins PJ, Clement ND, Hamilton DF, Gaston P, Patton JT, Howie CR. Predicting the cost-effectiveness of total hip and knee replacement: a health economic analysis. Bone Joint J. 2013 Jan;95-B(1):115-21. doi: 10.1302/0301-620X.95B1.29835. |
| 17403800 | Background | Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222. |
| 19844772 | Background | Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9. |
| 20798443 | Background | Scott CE, Howie CR, MacDonald D, Biant LC. Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010 Sep;92(9):1253-8. doi: 10.1302/0301-620X.92B9.24394. |
| 22357571 | Background | Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012. |
| 24262431 | Background | Giesinger K, Hamilton DF, Jost B, Holzner B, Giesinger JM. Comparative responsiveness of outcome measures for total knee arthroplasty. Osteoarthritis Cartilage. 2014 Feb;22(2):184-9. doi: 10.1016/j.joca.2013.11.001. Epub 2013 Nov 18. |
| 23109630 | Background | Hamilton DF, Gaston P, Simpson AH. Is patient reporting of physical function accurate following total knee replacement? J Bone Joint Surg Br. 2012 Nov;94(11):1506-10. doi: 10.1302/0301-620X.94B11.30081. |
| 22000572 | Background | Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13. |
| 23688851 | Background | Thienpont E, Opsomer G, Koninckx A, Houssiau F. Joint awareness in different types of knee arthroplasty evaluated with the Forgotten Joint score. J Arthroplasty. 2014 Jan;29(1):48-51. doi: 10.1016/j.arth.2013.04.024. Epub 2013 May 18. |
| 24269097 | Background | Klit J, Jacobsen S, Rosenlund S, Sonne-Holm S, Troelsen A. Total knee arthroplasty in younger patients evaluated by alternative outcome measures. J Arthroplasty. 2014 May;29(5):912-7. doi: 10.1016/j.arth.2013.09.035. Epub 2013 Oct 1. |
| 24201900 | Background | Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1744-58. doi: 10.1007/s00167-013-2750-2. Epub 2013 Nov 8. |
| 18679762 | Background | Singh JA, Gabriel S, Lewallen D. The impact of gender, age, and preoperative pain severity on pain after TKA. Clin Orthop Relat Res. 2008 Nov;466(11):2717-23. doi: 10.1007/s11999-008-0399-9. Epub 2008 Aug 5. |
| 23702267 | Background | Perez-Prieto D, Gil-Gonzalez S, Pelfort X, Leal-Blanquet J, Puig-Verdie L, Hinarejos P. Influence of depression on total knee arthroplasty outcomes. J Arthroplasty. 2014 Jan;29(1):44-7. doi: 10.1016/j.arth.2013.04.030. Epub 2013 May 20. |
| 24493186 | Background | Hanusch BC, O'Connor DB, Ions P, Scott A, Gregg PJ. Effects of psychological distress and perceptions of illness on recovery from total knee replacement. Bone Joint J. 2014 Feb;96-B(2):210-6. doi: 10.1302/0301-620X.96B2.31136. |
| 25339125 | Background | Dowsey MM, Nikpour M, Dieppe P, Choong PF. Associations between pre-operative radiographic osteoarthritis severity and pain and function after total hip replacement : Radiographic OA severity predicts function after THR. Clin Rheumatol. 2016 Jan;35(1):183-9. doi: 10.1007/s10067-014-2808-7. Epub 2014 Oct 24. |
| 23573200 | Background | Keurentjes JC, Fiocco M, So-Osman C, Onstenk R, Koopman-Van Gemert AW, Poll RG, Kroon HM, Vliet Vlieland TP, Nelissen RG. Patients with severe radiographic osteoarthritis have a better prognosis in physical functioning after hip and knee replacement: a cohort-study. PLoS One. 2013;8(4):e59500. doi: 10.1371/journal.pone.0059500. Epub 2013 Apr 3. |
| 24187370 | Background | Berend KR, Lombardi AV Jr, Adams JB. Which total knee replacement implant should I pick? Correcting the pathology: the role of knee bearing designs. Bone Joint J. 2013 Nov;95-B(11 Suppl A):129-32. doi: 10.1302/0301-620X.95B11.32835. |
| 23997134 | Background | van der Voort P, Pijls BG, Nouta KA, Valstar ER, Jacobs WC, Nelissen RG. A systematic review and meta-regression of mobile-bearing versus fixed-bearing total knee replacement in 41 studies. Bone Joint J. 2013 Sep;95-B(9):1209-16. doi: 10.1302/0301-620X.95B9.30386. |
| 24981991 | Background | Becker R, Hirschmann MT, Karlsson J. Does implant design and surgical technique improve the clinical outcome in total knee arthroplasty? Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1716-8. doi: 10.1007/s00167-014-3145-8. No abstract available. |
| 24903823 | Background | Nunley RM, Nam D, Berend KR, Lombardi AV, Dennis DA, Della Valle CJ, Barrack RL. New total knee arthroplasty designs: do young patients notice? Clin Orthop Relat Res. 2015 Jan;473(1):101-8. doi: 10.1007/s11999-014-3713-8. |
| 22844046 | Background | Baker PN, Deehan DJ, Lees D, Jameson S, Avery PJ, Gregg PJ, Reed MR. The effect of surgical factors on early patient-reported outcome measures (PROMS) following total knee replacement. J Bone Joint Surg Br. 2012 Aug;94(8):1058-66. doi: 10.1302/0301-620X.94B8.28786. |
| 24502700 | Background | Piepers MJ, van Hove RP, van den Bekerom MP, Nolte PA. Do refinements to original designs improve outcome of total knee replacement? A retrospective cohort study. J Orthop Surg Res. 2014 Feb 6;9:7. doi: 10.1186/1749-799X-9-7. |
| 20932707 | Background | Pritchett JW. Patients prefer a bicruciate-retaining or the medial pivot total knee prosthesis. J Arthroplasty. 2011 Feb;26(2):224-8. doi: 10.1016/j.arth.2010.02.012. Epub 2010 Oct 6. |
| 31604440 | Derived | Irmola T, Kangas J, Eskelinen A, Niemelainen M, Huhtala H, Mattila VM, Moilanen T. Functional outcome of total knee replacement: a study protocol for a prospective, double-blinded, parallel-group randomized, clinical controlled trial of novel, personalized and conventional implants. BMC Musculoskelet Disord. 2019 Oct 12;20(1):443. doi: 10.1186/s12891-019-2830-7. |
| D012216 |
| Rheumatic Diseases |