OsteoarthritisNCT04496102
Cemented vs Cementless in Bilateral TKA
A study testing Triathlon in people with Osteoarthritis and Total Knee Arthroplasty, run by Thammasat University at 1 site in Thailand.
Trial summary
To compare the functional outcomes between cemented and cementless TKA in bilateral knee replacement patient. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis, Total Knee Arthroplasty
- What is being tested?
- Triathlon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2020to Mar 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA status 1 or 2
- Diagnosed with bilateral osteoarthritis of the knees
- Participant understand and consent to the protocol of the trial
Who cannot join
- Morbid obesity (BMI >40)
- Inflammatory arthritis
- Osteoporosis
- Metabolic bone disease
- Bone defect that seen from radiographs
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Thammasat University
Khlong Luang, Changwat Pathum Thani, 12120
supakit kanitnate, M.D., +66899853635, naypeng@hotmail.com
Nattapol Tammachote, M.D.
About this study
Official title: Comparison of Efficacy Between Cemented and Cementless Total Knee Arthroplasty in Bilateral Total Knee Arthroplasty. A Prospective Randomized Controlled Trial
To compare the functional outcomes between cemented and cementless TKA in bilateral knee replacement patient.
Read the detailed description
To compare early functional outcomes, radiographic finding and operative time between cemented and cementless modern implant in sequential bilateral total kee arthroplasty.
- Conditions
- Osteoarthritis, Total Knee Arthroplasty
- Being tested
- Triathlon
- Keywords
- cemented, cementless, total knee arthroplasty, short term outcome, functional outcome
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriathlonDevice
Modern TKA design (Triathlon) with patellar resurfacing
| Study group | Role | What they receive |
|---|---|---|
| Cemented TKA | Active comparator | Cemented TKA (Triathlon, Stryker) include patellar resurfacing Receives: Device: Triathlon |
| Cementless TKA | Experimental | Cementless TKA (Triathlon Tritanium, Stryker) include patellar resurfacing Receives: Device: Triathlon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare mean Forgotten joint score between 2 groups
The total score ranges from 0-100, where a high score is the best outcome
Measured: at 1 year
Secondary outcomes (6)
Operative time
Measured: intra-operative assessment
modified the Western Ontario and McMaster Universities Osteoarthritis Index score
The total score ranges from 0-96, where a high score is the worse outcome
Measured: post-op 2, 6 week, 3, 6, 12 month
Pain level
VAS for pain (0-100)
Measured: Once daily 1-14 days after surgery then once a week until 3 months
Range of knee motion
flexion and extension (degrees) which measured by long goniometer
Measured: post-op 2, 6 week, 3, 6, 12 month
complication
such as fracture, infection, stiffness
Measured: until 1 year after surgery
Radiological finding
Radiolucent line at femoral, tibial and patellar components which measured from radiolucent intervals (measured in millimetres) between the cement or prostheses and the bone according to the knee society total knee arthroplasty roentgenographic evaluation and scoring system
Measured: post-op 2, 6 week, 3, 6, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start1 Mar 2020
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supakit Kanitnate, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496102
- Sponsor's protocol ID
- OrthoTU12
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tanariyakul Y, Kanitnate S, Tammachote N. Cementless and Cemented Total Knee Arthroplasties Have Similar Outcomes but Cementless Patellar Component Migration was Observed in a Paired Randomized Control Trial. J Arthroplasty. 2024 May;39(5):1266-1272. doi: 10.1016/j.arth.2023.10.055. Epub 2023 Nov 2.
PubMed 37924989
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy Between Cemented and Cementless Total Knee Arthroplasty in Bilateral Total Knee Arthroplasty. A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04496102
- Acronym / sponsor ID
- OrthoTU12
- Conditions
- Osteoarthritis, Total Knee Arthroplasty
- Keywords
- cemented, cementless, total knee arthroplasty, short term outcome, functional outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 3 Aug 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.
To compare the functional outcomes between cemented and cementless TKA in bilateral knee replacement patient.
Detailed description
To compare early functional outcomes, radiographic finding and operative time between cemented and cementless modern implant in sequential bilateral total kee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemented TKA | Active comparator | Device: TriathlonCemented TKA (Triathlon, Stryker) include patellar resurfacing |
| Cementless TKA | Experimental | Device: TriathlonCementless TKA (Triathlon Tritanium, Stryker) include patellar resurfacing |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA status 1 or 2
- Diagnosed with bilateral osteoarthritis of the knees
- Participant understand and consent to the protocol of the trial
Key exclusion criteria (5 listed)
- Morbid obesity (BMI >40)
- Inflammatory arthritis
- Osteoporosis
- Metabolic bone disease
- Bone defect that seen from radiographs
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 |
|---|---|---|
| TriathlonModern TKA design (Triathlon) with patellar resurfacing | Device | Cemented TKA, Cementless TKA |
Primary outcome
Compare mean Forgotten joint score between 2 groups
Time frame: at 1 year
The total score ranges from 0-100, where a high score is the best outcome
6 secondary outcomes
Operative time
Time frame: intra-operative assessment
modified the Western Ontario and McMaster Universities Osteoarthritis Index score
Time frame: post-op 2, 6 week, 3, 6, 12 month
Pain level
Time frame: Once daily 1-14 days after surgery then once a week until 3 months
Range of knee motion
Time frame: post-op 2, 6 week, 3, 6, 12 month
complication
Time frame: until 1 year after surgery
Radiological finding
Time frame: post-op 2, 6 week, 3, 6, 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Derived from this study: PubMed 37924989Tanariyakul Y, Kanitnate S, Tammachote N. Cementless and Cemented Total Knee Arthroplasties Have Similar Outcomes but Cementless Patellar Component Migration was Observed in a Paired Randomized Control Trial. J Arthroplasty. 2024 May;39(5):1266-1272. doi: 10.1016/j.arth.2023.10.055. Epub 2023 Nov 2.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triathlon in people with Osteoarthritis and Total Knee Arthroplasty, run by Thammasat University at 1 site in Thailand.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Aug 2020. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Supakit Kanitnate, M.D. (+66899853635, naypeng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare mean Forgotten joint score between 2 groups (time frame: at 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 NCT04496102, which also lists 1 linked publication.
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 3 Aug 2020.