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

Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06032507
• Other study ID #: IIBSP-HPL-2021-90
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: September 10, 2024

Study information

• Verified date: September 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 10, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 89 Years

Eligibility

Inclusion Criteria:

• Age >60 years

• Age <89 years

• Clinical symptoms of knee osteoarthritis

• Failed conservative treatment

Exclusion Criteria:

• Metal allergies

• Active or latent knee sepsis

• Extensor mechanism dysfunction

• Morbid obesity

• Several peripheral vascular disease

• Noncompliance due to major psychiatric or neurological disorders.

Related Conditions & MeSH terms

• Knee

Intervention

Procedure:
• Bone lavage previous to cementation
Bone lavage previous to cementation in total knee arthroplasty

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

References & Publications (9)

14. The Knee Society total knee arthroplasty roentgenographic evaluation and scoring system - PubMed. https://pubmed.ncbi.nlm.nih.gov/2805502/. Accessed March 17, 2021.

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, Avon). 2012 May;27(4):372-6. doi: 10.1016/j.clinbiomech.2011.10.006. Epub 2011 Nov 1. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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