Total Knee ArthroplastyNCT02798432
Hybrid Versus Cemented TKA Using the NexGen LPS Prosthesis
A study testing Total knee arthroplasty and NEXGEN LPS total knee arthroplasty in people with Total Knee Arthroplasty, run by Jesus Moreta Suarez at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Total knee arthroplasty and NEXGEN LPS total knee arthroplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be included in the study only if they meet the following criteria:
- Patient is able to provide informed consent.
- Patient is between 18 and 75 years of age.
- Patients are willing and able to attend all follow-up visits and complete all study requirements. They must agree to comply with all study related procedure, including understanding and adhering to the rehabilitation protocol.
- Patient has primary or secondary knee osteoarthritis.
- Patient has sufficient bone quality for total knee arthroplasty.
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- Patient is in stable health.
- Female patients are not pregnant at times of surgery and do not plan on becoming pregnant during the study.
- Note: patient can only enter the project with one knee
Who cannot join
- Neuromuscular or vascular disease in the affected leg.
- Patients with osteoporosis based on former diagnosis or preoperative DEXA-scan.
- Fracture sequelae or previous HTO or previous extensive knee surgery.
- Patients with need of a stem-elongation.
- Patients who cannot refrain from taking NSAID post-operatively.
- Patients with metabolic bone disease.
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- Patients with renal disease.
- Patients with rheumatoid arthritis.
- Postmenopausal women in estrogenic hormone substitution
- Patients with a continuous need of systemic cortisone treatment.
- Non-Spanish citizenship.
- Patients who do not comprehend the Spanish language (read and speak).
- Senile dementia.
- Alcohol abuse - defined as men drinking more than 21 units a week and women drinking more than 14 units a week.
- Drug abuse.
- Major psychiatric disease.
- Metastatic cancer disease and treatment with radiation therapy or chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Hybrid and Cemented TKA Using the NexGen LPS Prosthesis
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.
Read more
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
- Conditions
- Total Knee Arthroplasty
- Being tested
- Total knee arthroplasty, NEXGEN LPS total knee arthroplasty
- Keywords
- Total Knee Arthroplasty, Hybrid, Cemented, Fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Use of an uncemented femoral component or a cemented femoral component randomly assigned.
NEXGEN LPS total knee arthroplastyDevice
Hybrid (non cemented femoral component, cemented tibial component) NEXGEN LPS total knee arthroplasty versus Cemented NEXGEN LPS total knee arthroplasty (both components are cemented).
| Study group | Role | What they receive |
|---|---|---|
| Hybrid NEXGEN LPS | Experimental | Noncemented femoral component with cemented tibial component with the NexGen LPS Total Knee Arthroplasty Receives: Procedure: Total knee arthroplasty; Device: NEXGEN LPS total knee arthroplasty |
| Cemented NEXGEN LPS | Sham comparator | Cemented femoral component with cemented tibial component with the NexGen LPS Total Knee Arthroplasty Receives: Procedure: Total knee arthroplasty; Device: NEXGEN LPS total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 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).
Measured: up until 10 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionMar 2018
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jesus Moreta Suarez
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Jesus Moreta Suarez, Hospital Galdakao-Usansolo
- Investigators
- Jesus Moreta, MD, FEBOT, Principal investigator, Hospital Galdakao-Usansolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798432
- Sponsor's protocol ID
- CSE2013-07K
- Status last verified
- Jul 2018
- First submitted
- 20 Apr 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no plan to share data
Publications
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.
PubMed 9926947Carlsson 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.
PubMed 16156464Huddleston 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.
PubMed 16331023Uvehammer 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.
PubMed 17259414Illgen 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.
PubMed 15457426Dunbar 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.
PubMed 19571079
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Hybrid and Cemented TKA Using the NexGen LPS Prosthesis
- ClinicalTrials.gov ID
- NCT02798432
- Acronym / sponsor ID
- CSE2013-07K
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Hybrid, Cemented, Fixation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Jesus Moreta SuarezOther government
- Study start
- Jun 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Jun 2016 (estimated)
- 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid NEXGEN LPS | Experimental | Procedure: Total knee arthroplasty, Device: NEXGEN LPS total knee arthroplastyNoncemented femoral component with cemented tibial component with the NexGen LPS Total Knee Arthroplasty |
| Cemented NEXGEN LPS | Sham comparator | Procedure: Total knee arthroplasty, Device: NEXGEN LPS total knee arthroplastyCemented femoral component with cemented tibial component with the NexGen LPS Total Knee Arthroplasty |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient is able to provide informed consent.
- Patient is between 18 and 75 years of age.
- Patients are willing and able to attend all follow-up visits and complete all study requirements. They must agree to comply with all study related procedure, including understanding and adhering to the rehabilitation protocol.
- Patient has primary or secondary knee osteoarthritis.
- Patient has sufficient bone quality for total knee arthroplasty.
Key exclusion criteria (17 listed)
- Neuromuscular or vascular disease in the affected leg.
- Patients with osteoporosis based on former diagnosis or preoperative DEXA-scan.
- Fracture sequelae or previous HTO or previous extensive knee surgery.
- Patients with need of a stem-elongation.
- Patients who cannot refrain from taking NSAID post-operatively.
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 |
|---|---|---|
| Total knee arthroplastyUse of an uncemented femoral component or a cemented femoral component randomly assigned. | Procedure or surgery | Cemented NEXGEN LPS, Hybrid NEXGEN LPS |
| NEXGEN LPS total knee arthroplastyHybrid (non cemented femoral component, cemented tibial component) NEXGEN LPS total knee arthroplasty versus Cemented NEXGEN LPS total knee arthroplasty (both components are cemented). | Device | Cemented NEXGEN LPS, Hybrid NEXGEN LPS |
Primary outcome
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.
Time frame: 1 year
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.
2 secondary outcomes
Incidence and extend of radiolucent lines (RLL) as measured by standard radiography.
Time frame: Up to 10 years.
Postoperative functional outcome as measured by Knee Society Score.
Time frame: up until 10 years of follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Results publication: PubMed 9926947Nilsson 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.
- Results publication: PubMed 16156464Carlsson 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.
- Results publication: PubMed 16331023Huddleston 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.
- Results publication: PubMed 17259414Uvehammer 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.
- Results publication: PubMed 15457426Illgen 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.
- Results publication: PubMed 19571079Dunbar 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.
- Individual participant dataSharing planned: No. There is no plan to share data
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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.
Jesus Moreta, MD, FEBOT principal investigator
Hospital Galdakao-Usansolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty and NEXGEN LPS total knee arthroplasty in people with Total Knee Arthroplasty, run by Jesus Moreta Suarez 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 9 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 2 Aug 2018. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
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. (time frame: 1 year). 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 NCT02798432, which also lists 6 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 2 Aug 2018.