KneeNCT06032507
Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty
A study testing Bone lavage previous to cementation in people with Knee, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee
- What is being tested?
- Bone lavage previous to cementation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >60 years
- Age <89 years
- Clinical symptoms of knee osteoarthritis
- Failed conservative treatment
Who cannot join
- Metal allergies
- Active or latent knee sepsis
- Extensor mechanism dysfunction
- Morbid obesity
- Several peripheral vascular disease
- Noncompliance due to major psychiatric or neurological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty - A Randomized Clinical Trial
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.
Read more
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
- Being tested
- Bone lavage previous to cementation
- Keywords
- Total Knee Arthroplasty Cementation, Bone cement penetration, High Pressure Pulsatile Lavage, Pulsatile lavage, Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone lavage previous to cementationProcedure or surgery
Bone lavage previous to cementation in total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Pulsed lavagegroup | Experimental | Bone cementation with previous high-pressure pulsatile lavage Receives: Procedure: Bone lavage previous to cementation |
| Non-pulsed lavage group | Experimental | Bone cementation with previous manual rinsing lavage Receives: Procedure: Bone lavage previous to cementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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-.
Measured: 48 hours postoperative xrays
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Mar 2022
- Primary completion1 Mar 2023
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for KneeStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 100 patients undergoing primary TKA
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032507
- Sponsor's protocol ID
- IIBSP-HPL-2021-90
- Status last verified
- Sep 2023
- First submitted
- 23 Feb 2022
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 12439231Peters 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.
PubMed 12671498Maistrelli 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.
PubMed 7634612Clarius 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.
PubMed 22051198Jaeger 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.
PubMed 23790498Ritter 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.
PubMed 828866614. The Knee Society total knee arthroplasty roentgenographic evaluation and scoring system - PubMed. https://pubmed.ncbi.nlm.nih.gov/2805502/. Accessed March 17, 2021.
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.
PubMed 32780155Schlegel 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.
PubMed 25082179Ramirez-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.
PubMed 41188974
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06032507
- Acronym / sponsor ID
- IIBSP-HPL-2021-90
- Conditions
- Knee
- Keywords
- Total Knee Arthroplasty Cementation, Bone cement penetration, High Pressure Pulsatile Lavage, Pulsatile lavage, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 100 patients undergoing primary TKA
| Arm | Type | Receives |
|---|---|---|
| Pulsed lavagegroup | Experimental | Procedure: Bone lavage previous to cementationBone cementation with previous high-pressure pulsatile lavage |
| Non-pulsed lavage group | Experimental | Procedure: Bone lavage previous to cementationBone cementation with previous manual rinsing lavage |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >60 years
- Age <89 years
- Clinical symptoms of knee osteoarthritis
- Failed conservative treatment
Key exclusion criteria (6 listed)
- Metal allergies
- Active or latent knee sepsis
- Extensor mechanism dysfunction
- Morbid obesity
- Several peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone lavage previous to cementationBone lavage previous to cementation in total knee arthroplasty | Procedure or surgery | Non-pulsed lavage group, Pulsed lavagegroup |
Primary outcome
Cumulative bone cement penetration
Time frame: 48 hours postoperative xrays
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-.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 12439231Sharkey 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.
- Background: PubMed 12671498Peters 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.
- Background: PubMed 7634612Maistrelli 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.
- Background: PubMed 22051198Clarius 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.
- Background: PubMed 23790498Jaeger 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.
- Background: PubMed 8288666Ritter 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.
- Background14. The Knee Society total knee arthroplasty roentgenographic evaluation and scoring system - PubMed. https://pubmed.ncbi.nlm.nih.gov/2805502/. Accessed March 17, 2021.
- Background: PubMed 32780155Wing 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.
- Background: PubMed 25082179Schlegel 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.
- Derived from this study: PubMed 41188974Ramirez-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone lavage previous to cementation in people with Knee, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative bone cement penetration (time frame: 48 hours postoperative xrays). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06032507, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.