Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty
NCT ID: NCT06032507
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2022-03-01
2024-09-10
Brief Summary
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Bone irrigation is essential in cemented total knee arthroplasty surgical technique in order to improve cement penetration and interdigitation into cancellous bone, that is going to determine the strength of the bone-cement interface.
Purpose
To report the effect of high-pressure pulsatile lavage versus manual rinsing on bone cement penetration in total knee arthroplasty.
Methods
This is a single-centre, prospective, randomized, controlled clinical trial. The study included 100 patients undergoing primary total knee arthroplasty. All patients meeting inclusion criteria were randomly assigned to the pulsed lavage or non-pulsed lavage group. The cumulative bone cement penetration was radiologically assessed in antero posterior and lateral radiograph views in 10 zones according to the Knee Society Scoring System. A statistical analysis was performed between both groups comparing bone cement penetration cumulative scores.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pulsed lavagegroup
Bone cementation with previous high-pressure pulsatile lavage
Bone lavage previous to cementation
Bone lavage previous to cementation in total knee arthroplasty
Non-pulsed lavage group
Bone cementation with previous manual rinsing lavage
Bone lavage previous to cementation
Bone lavage previous to cementation in total knee arthroplasty
Interventions
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Bone lavage previous to cementation
Bone lavage previous to cementation in total knee arthroplasty
Eligibility Criteria
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Inclusion Criteria
* Age \<89 years
* Clinical symptoms of knee osteoarthritis
* Failed conservative treatment
Exclusion Criteria
* Active or latent knee sepsis
* Extensor mechanism dysfunction
* Morbid obesity
* Several peripheral vascular disease
* Noncompliance due to major psychiatric or neurological disorders.
60 Years
89 Years
ALL
Yes
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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References
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Sharkey PF, Hozack WJ, Rothman RH, Shastri S, Jacoby SM. Insall Award paper. Why are total knee arthroplasties failing today? Clin Orthop Relat Res. 2002 Nov;(404):7-13. doi: 10.1097/00003086-200211000-00003.
Peters CL, Craig MA, Mohr RA, Bachus KN. Tibial component fixation with cement: full- versus surface-cementation techniques. Clin Orthop Relat Res. 2003 Apr;(409):158-68. doi: 10.1097/01.blo.0000058638.94987.20.
Maistrelli GL, Antonelli L, Fornasier V, Mahomed N. Cement penetration with pulsed lavage versus syringe irrigation in total knee arthroplasty. Clin Orthop Relat Res. 1995 Mar;(312):261-5.
Clarius M, Seeger JB, Jaeger S, Mohr G, Bitsch RG. The importance of pulsed lavage on interface temperature and ligament tension force in cemented unicompartmental knee arthroplasty. Clin Biomech (Bristol). 2012 May;27(4):372-6. doi: 10.1016/j.clinbiomech.2011.10.006. Epub 2011 Nov 1.
Jaeger S, Seeger JB, Schuld C, Bitsch RG, Clarius M. Tibial cementing in UKA: a three-dimensional analysis of the bone cement implant interface and the effect of bone lavage. J Arthroplasty. 2013 Oct;28(9 Suppl):191-4. doi: 10.1016/j.arth.2013.05.014. Epub 2013 Jun 21.
Ritter MA, Herbst SA, Keating EM, Faris PM. Radiolucency at the bone-cement interface in total knee replacement. The effects of bone-surface preparation and cement technique. J Bone Joint Surg Am. 1994 Jan;76(1):60-5. doi: 10.2106/00004623-199401000-00008.
Ewald FC. The Knee Society total knee arthroplasty roentgenographic evaluation and scoring system. Clin Orthop Relat Res. 1989 Nov;(248):9-12.
Wing N, Van Zyl N, Wing M, Corrigan R, Loch A, Wall C. Reliability of three radiographic classification systems for knee osteoarthritis among observers of different experience levels. Skeletal Radiol. 2021 Feb;50(2):399-405. doi: 10.1007/s00256-020-03551-4. Epub 2020 Aug 11.
Schlegel UJ, Bishop NE, Puschel K, Morlock MM, Nagel K. Comparison of different cement application techniques for tibial component fixation in TKA. Int Orthop. 2015 Jan;39(1):47-54. doi: 10.1007/s00264-014-2468-x. Epub 2014 Aug 1.
Ramirez-Bermejo E, Fa-Binefa M, Pilco-Inga J, Jordan-Sales M, Aguilera-Roig X, Gonzalez-Rodriguez JC. Effect of high-pressure pulsatile lavage versus manual rinsing on bone cement penetration in total knee arthroplasty: a randomized clinical trial. Knee Surg Relat Res. 2025 Nov 4;37(1):47. doi: 10.1186/s43019-025-00298-x.
Other Identifiers
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IIBSP-HPL-2021-90
Identifier Type: -
Identifier Source: org_study_id
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