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Early total knee arthroplasty (TKA) implant systems most frequently used an all-polyethylene cemented tibial component1. Based on finite-element analysis studies reporting superior force distribution compared with conventional all-polyethylene components, metal-backed tibial baseplates have dominated the TKA implant market since the middle of the 1980's2. These modular implants provided excellent long-term implant survivorship3.
As TKA became increasingly successful, younger patients increasingly became eligible. Increasing life expectancy has raised the concern that cemented TKAs may not withstand prolonged use, particularly in younger patients4. Patients younger than 65 years are projected to account for more than 50% of patients undergoing TKA by 2016 and to more than 50% of patients undergoing revision surgery by 2011. The number of total knee revisions in the United States is expected to increase from 38,300 in 2005 to 268,200 in 20305.
Many authors have reported excellent and equivalent results of cemented and cementless TKA6-8. Despite these encouraging reports, the major concern with cementless TKA has been the tibial component, and, therefore, the preference for many surgeons still remains to cement the tibial component9,10. The femoral component may be the most suitable for cementless fixation11-13. However, the best femoral method of fixation is still being discussed. Currently, the decision to cement or not to cement the femoral component is based on the surgeon's preference14.
The current study was designed to compare the hybrid NexGen LPS (Zimmer Inc, Warsaw, IN) and the cemented NexGen LPS. The purpose of this study is to establish whether the hybrid NexGen LPS leads to equally successful results as the cemented TKA gold standard
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid NEXGEN LPS | Experimental | Noncemented femoral component with cemented tibial component with the NexGen LPS Total Knee Arthroplasty |
|
| Cemented NEXGEN LPS | Sham Comparator | Cemented femoral component with cemented tibial component with the NexGen LPS Total Knee Arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty | Procedure | Use of an uncemented femoral component or a cemented femoral component randomly assigned. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative functional outcome as measured by the Knee and Osteoarthritis Outcome Score (KOOS) and compare if hybrid NexGen LPS TKA leads to equally successful results as the cemented NexGen LPS TKA. | The current study will be designed as equivalence trial. The amount of allowable difference is the margin that defines the "zone of indifference" within which the interventions are considered equivalent. The KOOS has a Minimally Clinically Important Difference (MCID) of 8 - 10 points, and the standard deviation in a cohort of TKA patients is ca. 15 points. The null hypothesis (of non-equivalence) of the study is that functional outcome at 10 years of follow-up in the hybrid group is not equal to the functional outcome at 10 years of follow-up in the cemented group, or: H: ϑ ≤ ϑ0 - δ1 or ϑ ≥ ϑ0 + δ1, versus the equivalence assumption that functional outcome at 10 years of follow-up in the hybrid group is equivalent to the functional outcome at 10 years of follow-up in the cemented group: K: ϑ0 - δ1 < ϑ < ϑ0 + δ1. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and extend of radiolucent lines (RLL) as measured by standard radiography. | Radiography: x-rays will be taken during visit 4 and visits 7-10. Conventional anteroposterior and lateral radiographs will be taken at designated time-points. In order to obtain "true orthogonal" radiographs and to reduce the probability of false-negative findings, the lateral image will be obtained under fluoroscopic control. Postoperative radiographs will assess component position and alignment, the incidence and location of radiolucent lines using the Knee Society TKA radiographic evaluation system. |
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Inclusion Criteria:
Patients may be included in the study only if they meet the following criteria:
Note: patient can only enter the project with one knee
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesus Moreta, MD, FEBOT | Hospital Galdakao-Usansolo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Galdakao-Usansolo | Galdakao | Bizkaia | 48980 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9926947 | Result | Nilsson KG, Karrholm J, Carlsson L, Dalen T. Hydroxyapatite coating versus cemented fixation of the tibial component in total knee arthroplasty: prospective randomized comparison of hydroxyapatite-coated and cemented tibial components with 5-year follow-up using radiostereometry. J Arthroplasty. 1999 Jan;14(1):9-20. doi: 10.1016/s0883-5403(99)90196-1. | |
| 16156464 |
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There is no plan to share data
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| NEXGEN LPS total knee arthroplasty | Device | Hybrid (non cemented femoral component, cemented tibial component) NEXGEN LPS total knee arthroplasty versus Cemented NEXGEN LPS total knee arthroplasty (both components are cemented). |
|
| Up to 10 years. |
| Postoperative functional outcome as measured by Knee Society Score. | The KSS is a questionnaire validate in Spanish.The study regimen for each patient will consist of a screening / baseline phase (Visit 1), follow-up visits (Visits 3 - 9) and a conclusion visit (Visit 10). All procedures specified in this protocol must be documented in the patient's record and on the corresponding Case Report Form (CRF). | up until 10 years of follow up |
| Carlsson A, Bjorkman A, Besjakov J, Onsten I. Cemented tibial component fixation performs better than cementless fixation: a randomized radiostereometric study comparing porous-coated, hydroxyapatite-coated and cemented tibial components over 5 years. Acta Orthop. 2005 Jun;76(3):362-9. |
| 16331023 | Result | Huddleston JI, Wiley JW, Scott RD. Zone 4 femoral radiolucent lines in hybrid versus cemented total knee arthroplasties: are they clinically significant? Clin Orthop Relat Res. 2005 Dec;441:334-9. doi: 10.1097/01.blo.0000180452.11048.b8. |
| 17259414 | Result | Uvehammer J, Karrholm J, Carlsson L. Cemented versus hydroxyapatite fixation of the femoral component of the Freeman-Samuelson total knee replacement: a radiostereometric analysis. J Bone Joint Surg Br. 2007 Jan;89(1):39-44. doi: 10.1302/0301-620X.89B1.17974. |
| 15457426 | Result | Illgen R, Tueting J, Enright T, Schreibman K, McBeath A, Heiner J. Hybrid total knee arthroplasty: a retrospective analysis of clinical and radiographic outcomes at average 10 years follow-up. J Arthroplasty. 2004 Oct;19(7 Suppl 2):95-100. doi: 10.1016/j.arth.2004.06.022. |
| 19571079 | Result | Dunbar MJ, Wilson DA, Hennigar AW, Amirault JD, Gross M, Reardon GP. Fixation of a trabecular metal knee arthroplasty component. A prospective randomized study. J Bone Joint Surg Am. 2009 Jul;91(7):1578-86. doi: 10.2106/JBJS.H.00282. |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |