Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty

NCT06032507 | Completed DMC

• 1 other identifier: IIBSP-HPL-2021-90
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background 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.

Conditions

Knee

Keywords

Total Knee Arthroplasty Cementation; Bone cement penetration; High Pressure Pulsatile Lavage; Pulsatile lavage; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Cumulative bone cement penetration

  The cumulative bone cement penetration was radiologically assessed in AP and lateral radiograph views in 10 zones according to the Knee Society Scoring System (for each zone, \<4 = nonprogressive, 5-9 = risk of progression, \>10 = risk of failure) - minimum 0, maximum non established-.

  48 hours postoperative xrays

Study Arms (2)

Pulsed lavagegroup

EXPERIMENTAL

Bone cementation with previous high-pressure pulsatile lavage

Procedure: Bone lavage previous to cementation

Non-pulsed lavage group

EXPERIMENTAL

Bone cementation with previous manual rinsing lavage

Procedure: Bone lavage previous to cementation

Interventions

Bone lavage previous to cementation PROCEDURE

Bone lavage previous to cementation in total knee arthroplasty

Non-pulsed lavage group; Pulsed lavagegroup

Eligibility Criteria

• Age: 60 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>60 years
• Age \<89 years
• Clinical symptoms of knee osteoarthritis
• Failed conservative treatment

You may not qualify if:

• Metal allergies
• Active or latent knee sepsis
• Extensor mechanism dysfunction
• Morbid obesity
• Several peripheral vascular disease
• Noncompliance due to major psychiatric or neurological disorders.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Related Publications (10)

• 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.

  PMID: 12439231 BACKGROUND

• 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.

  PMID: 12671498 BACKGROUND

• 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.

  PMID: 7634612 BACKGROUND

• 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.

  PMID: 22051198 BACKGROUND

• 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.

  PMID: 23790498 BACKGROUND

• 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.

  PMID: 8288666 BACKGROUND

• Ewald FC. The Knee Society total knee arthroplasty roentgenographic evaluation and scoring system. Clin Orthop Relat Res. 1989 Nov;(248):9-12.

  PMID: 2805502 BACKGROUND

• 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.

  PMID: 32780155 BACKGROUND

• 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.

  PMID: 25082179 BACKGROUND

• 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.

  PMID: 41188974 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 100 patients undergoing primary TKA

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: September 13, 2023
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: September 10, 2024
• Last Updated: November 18, 2025

Record last verified: 2023-09

Locations

ES (1)