Total Knee Arthroplasty (TKA)NCT04597684
Cemented vs. Cementless TKA
A study testing Cementless Total Knee Arthroplasty and Cemented Total Knee Arthroplasty in people with Total Knee Arthroplasty (TKA), run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
The investigators are evaluating an implant (Depuy Attune TKA) that was recently released to market with a cementless design that is yet to have long term comparative data between this cementless design or cemented options. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Total Knee Arthroplasty (TKA)
- What is being tested?
- Cementless Total Knee Arthroplasty and Cemented Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2020to 21 Oct 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evaluation for TKA at OrthoCarolina
- Evaluated and scheduled for TKA by Drs. Keith Fehring, Bo Mason, William Griffin, Thomas Fehring, or Jesse Otero
- Determined by the above surgeon to be a candidate for the Attune Posterior Stabilized knee system, with the patella to be resurfaced during surgery
- >18 years of age at enrollment
Who cannot join
- Previous surgery with hardware on the joint of interest
- >= 65 years old at the time of TKA surgery
- Previous diagnosis of inflammatory disease (RA, inflammatory arthropathy, any autoimmune disease)
- BMI <= 40
- Physician discretion due to not being able to follow standard-of-care (SOC) TKA follow up protocol
- History of contralateral TKA
- Current Tobacco Use
Trial locations and contacts
1 site in 1 country.
United States1 site
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
About this study
Official title: What Are the Results of Cemented vs. Cementless TKA With the Same Implant Design? A Randomized Clinical Trial.
The investigators are evaluating an implant (Depuy Attune TKA) that was recently released to market with a cementless design that is yet to have long term comparative data between this cementless design or cemented options. The investigators are conducting a study to compare the results of this cementless design to the cemented design of the same implant.
Read the detailed description
Aseptic Loosening remains a leading cause for revision following TKA. Cemented TKAs have shown high failure rates in obese and younger populations. There is renewed interest in biologic fixation of total knee components with a more active and younger patient population, as well as long term alternatives in obese patients receiving TKA.
Questions remain whether cemented or cementless long term fixation is superior in total knee arthroplasty in these populations.
Potential benefits of cementless fixation include preservation of bone, decreased operative times, and elimination of complications specific to cemented components. Older cementless TKA designs had higher failure rates due to poor fixation methods, patch porous coating on the implant, poor tibial locking mechanisms and the use of conventional polyethylene. The combination of these factors led to unacceptable failure rates in these devices. Newer designs have looked to improve these flaws with advances in the biologic interface, use of highly porous metals, improved locking mechanisms, and cross-linked polyethylene.
Recently, cementless implants with these improved design features have shown improved long term outcomes of cementless components versus their cemented predecessors. The combination of these improved long term outcomes in younger, more active population warrant further investigation of cementless components in TKA. There is a need for more durable, long term fixation in all implants treating obese, as well as young active patients.
The investigators are evaluating an implant (Depuy Attune TKA) that was recently released to market with a cementless design that is yet to have long term comparative data between this cementless design or cemented options. The investigators are conducting a study to compare the results of this cementless design to the cemented design of the same implant.
- Conditions
- Total Knee Arthroplasty (TKA)
- Being tested
- Cementless Total Knee Arthroplasty, Cemented Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cementless Total Knee ArthroplastyProcedure or surgery
Also called Treatment/Intervention
Total Knee Arthroplasty (TKA) with cementless knees
Cemented Total Knee ArthroplastyProcedure or surgery
Also called Control
Total Knee Arthroplasty (TKA) with cemented knees
| Study group | Role | What they receive |
|---|---|---|
| Treatment/Intervention | Active comparator | Total Knee Arthroplasty (TKA) with cementless knees Receives: Procedure: Cementless Total Knee Arthroplasty |
| Control | Active comparator | Total Knee Arthroplasty (TKA) with cemented knees Receives: Procedure: Cemented Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision for loosening
Did the subject have a revision procedure due to loosening (yes/no)
Measured: Within 20 years of study surgery
Secondary outcomes (3)
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.)
Patient-reported outcome of knee stiffness, pain, and function of daily living.
Measured: PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year
The Veterans RAND 12-Item Health Survey (VR-12)
General Health survey
Measured: PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year
Radiographic evidence of loosening
Radiographic evidence of loosening
Measured: PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start29 Sep 2020
- Primary completion21 Oct 2021
- Study completion21 Oct 2021
Why it stopped: Enrollment volume below acceptable accrual rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Total Knee Arthroplasty (TKA)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith A Fehring, MD, Principal investigator, OrthoCarolina Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597684
- Sponsor's protocol ID
- HK226
- Status last verified
- Mar 2022
- First submitted
- 9 Oct 2020
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared with other researchers.
Publications
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686Miller AJ, Stimac JD, Smith LS, Feher AW, Yakkanti MR, Malkani AL. Results of Cemented vs Cementless Primary Total Knee Arthroplasty Using the Same Implant Design. J Arthroplasty. 2018 Apr;33(4):1089-1093. doi: 10.1016/j.arth.2017.11.048. Epub 2017 Dec 2.
PubMed 29275115Nam D, Lawrie CM, Salih R, Nahhas CR, Barrack RL, Nunley RM. Cemented Versus Cementless Total Knee Arthroplasty of the Same Modern Design: A Prospective, Randomized Trial. J Bone Joint Surg Am. 2019 Jul 3;101(13):1185-1192. doi: 10.2106/JBJS.18.01162.
PubMed 31274720Fricka KB, Sritulanondha S, McAsey CJ. To Cement or Not? Two-Year Results of a Prospective, Randomized Study Comparing Cemented Vs. Cementless Total Knee Arthroplasty (TKA). J Arthroplasty. 2015 Sep;30(9 Suppl):55-8. doi: 10.1016/j.arth.2015.04.049. Epub 2015 Jun 3.
PubMed 26118567Abdel MP, Bonadurer GF 3rd, Jennings MT, Hanssen AD. Increased Aseptic Tibial Failures in Patients With a BMI >/=35 and Well-Aligned Total Knee Arthroplasties. J Arthroplasty. 2015 Dec;30(12):2181-4. doi: 10.1016/j.arth.2015.06.057. Epub 2015 Jul 2.
PubMed 26220103Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.
PubMed 22398175Brown TE, Harper BL, Bjorgul K. Comparison of cemented and uncemented fixation in total knee arthroplasty. Orthopedics. 2013 May;36(5):380-7. doi: 10.3928/01477447-20130426-10.
PubMed 23672897Lombardi AV Jr, Berasi CC, Berend KR. Evolution of tibial fixation in total knee arthroplasty. J Arthroplasty. 2007 Jun;22(4 Suppl 1):25-9. doi: 10.1016/j.arth.2007.02.006.
PubMed 17570273
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Results of Cemented vs. Cementless TKA With the Same Implant Design? A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04597684
- Acronym / sponsor ID
- HK226
- Conditions
- Total Knee Arthroplasty (TKA)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment volume below acceptable accrual rate.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 22 Oct 2020 (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.
The investigators are evaluating an implant (Depuy Attune TKA) that was recently released to market with a cementless design that is yet to have long term comparative data between this cementless design or cemented options. The investigators are conducting a study to compare the results of this cementless design to the cemented design of the same implant.
Detailed description
Aseptic Loosening remains a leading cause for revision following TKA. Cemented TKAs have shown high failure rates in obese and younger populations. There is renewed interest in biologic fixation of total knee components with a more active and younger patient population, as well as long term alternatives in obese patients receiving TKA.
Questions remain whether cemented or cementless long term fixation is superior in total knee arthroplasty in these populations.
Potential benefits of cementless fixation include preservation of bone, decreased operative times, and elimination of complications specific to cemented components. Older cementless TKA designs had higher failure rates due to poor fixation methods, patch porous coating on the implant, poor tibial locking mechanisms and the use of conventional polyethylene. The combination of these factors led to unacceptable failure rates in these devices. Newer designs have looked to improve these flaws with advances in the biologic interface, use of highly porous metals, improved locking mechanisms, and cross-linked polyethylene.
Recently, cementless implants with these improved design features have shown improved long term outcomes of cementless components versus their cemented predecessors. The combination of these improved long term outcomes in younger, more active population warrant further investigation of cementless components in TKA. There is a need for more durable, long term fixation in all implants treating obese, as well as young active patients.
The investigators are evaluating an implant (Depuy Attune TKA) that was recently released to market with a cementless design that is yet to have long term comparative data between this cementless design or cemented options. The investigators are conducting a study to compare the results of this cementless design to the cemented design of the same implant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment/Intervention | Active comparator | Procedure: Cementless Total Knee ArthroplastyTotal Knee Arthroplasty (TKA) with cementless knees |
| Control | Active comparator | Procedure: Cemented Total Knee ArthroplastyTotal Knee Arthroplasty (TKA) with cemented knees |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Evaluation for TKA at OrthoCarolina
- Evaluated and scheduled for TKA by Drs. Keith Fehring, Bo Mason, William Griffin, Thomas Fehring, or Jesse Otero
- Determined by the above surgeon to be a candidate for the Attune Posterior Stabilized knee system, with the patella to be resurfaced during surgery
- >18 years of age at enrollment
Key exclusion criteria (7 listed)
- Previous surgery with hardware on the joint of interest
- >= 65 years old at the time of TKA surgery
- Previous diagnosis of inflammatory disease (RA, inflammatory arthropathy, any autoimmune disease)
- BMI <= 40
- Physician discretion due to not being able to follow standard-of-care (SOC) TKA follow up protocol
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 |
|---|---|---|
| Cementless Total Knee ArthroplastyAlso: Treatment/InterventionTotal Knee Arthroplasty (TKA) with cementless knees | Procedure or surgery | Treatment/Intervention |
| Cemented Total Knee ArthroplastyAlso: ControlTotal Knee Arthroplasty (TKA) with cemented knees | Procedure or surgery | Control |
Primary outcome
Revision for loosening
Time frame: Within 20 years of study surgery
Did the subject have a revision procedure due to loosening (yes/no)
3 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.)
Time frame: PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year
The Veterans RAND 12-Item Health Survey (VR-12)
Time frame: PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year
Radiographic evidence of loosening
Time frame: PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year
Results and safety
The study was stopped early (reason given: Enrollment volume below acceptable accrual rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Background: PubMed 29275115Miller AJ, Stimac JD, Smith LS, Feher AW, Yakkanti MR, Malkani AL. Results of Cemented vs Cementless Primary Total Knee Arthroplasty Using the Same Implant Design. J Arthroplasty. 2018 Apr;33(4):1089-1093. doi: 10.1016/j.arth.2017.11.048. Epub 2017 Dec 2.
- Background: PubMed 31274720Nam D, Lawrie CM, Salih R, Nahhas CR, Barrack RL, Nunley RM. Cemented Versus Cementless Total Knee Arthroplasty of the Same Modern Design: A Prospective, Randomized Trial. J Bone Joint Surg Am. 2019 Jul 3;101(13):1185-1192. doi: 10.2106/JBJS.18.01162.
- Background: PubMed 26118567Fricka KB, Sritulanondha S, McAsey CJ. To Cement or Not? Two-Year Results of a Prospective, Randomized Study Comparing Cemented Vs. Cementless Total Knee Arthroplasty (TKA). J Arthroplasty. 2015 Sep;30(9 Suppl):55-8. doi: 10.1016/j.arth.2015.04.049. Epub 2015 Jun 3.
- Background: PubMed 26220103Abdel MP, Bonadurer GF 3rd, Jennings MT, Hanssen AD. Increased Aseptic Tibial Failures in Patients With a BMI >/=35 and Well-Aligned Total Knee Arthroplasties. J Arthroplasty. 2015 Dec;30(12):2181-4. doi: 10.1016/j.arth.2015.06.057. Epub 2015 Jul 2.
- Background: PubMed 22398175Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.
- Background: PubMed 23672897Brown TE, Harper BL, Bjorgul K. Comparison of cemented and uncemented fixation in total knee arthroplasty. Orthopedics. 2013 May;36(5):380-7. doi: 10.3928/01477447-20130426-10.
- Background: PubMed 17570273Lombardi AV Jr, Berasi CC, Berend KR. Evolution of tibial fixation in total knee arthroplasty. J Arthroplasty. 2007 Jun;22(4 Suppl 1):25-9. doi: 10.1016/j.arth.2007.02.006.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared with other researchers.
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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.
Keith A Fehring, MD principal investigator
OrthoCarolina Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cementless Total Knee Arthroplasty and Cemented Total Knee Arthroplasty in people with Total Knee Arthroplasty (TKA), run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
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 7 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: stopped early, as of the sponsor's last update on 8 Apr 2022. 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 United States. 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 was stopped early (reason given: Enrollment volume below acceptable accrual rate.). Results are not available in the source record.
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?
Revision for loosening (time frame: Within 20 years of study surgery). 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 NCT04597684, which also lists 8 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 8 Apr 2022.