- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04496102
Cemented vs Cementless in Bilateral TKA
July 30, 2020 updated by: Supakit Kanitnate, Thammasat University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: supakit kanitnate, M.D.
- Phone Number: +66899853635
- Email: naypeng@hotmail.com
Study Locations
-
-
Pathum Thani
-
Khlong Luang, Pathum Thani, Thailand, 12120
- Recruiting
- Thammasat University
-
Contact:
- supakit kanitnate, M.D.
- Phone Number: +66899853635
- Email: naypeng@hotmail.com
-
Principal Investigator:
- Nattapol Tammachote, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA status 1 or 2
- Diagnosed with bilateral osteoarthritis of the knees
- Participant understand and consent to the protocol of the trial
Exclusion Criteria:
- Morbid obesity (BMI >40)
- Inflammatory arthritis
- Osteoporosis
- Metabolic bone disease
- Bone defect that seen from radiographs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Cemented TKA
Cemented TKA (Triathlon, Stryker) include patellar resurfacing
|
Modern TKA design (Triathlon) with patellar resurfacing
|
EXPERIMENTAL: Cementless TKA
Cementless TKA (Triathlon Tritanium, Stryker) include patellar resurfacing
|
Modern TKA design (Triathlon) with patellar resurfacing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative time
Time Frame: intra-operative assessment
|
intra-operative assessment
|
|
modified the Western Ontario and McMaster Universities Osteoarthritis Index score
Time Frame: post-op 2, 6 week, 3, 6, 12 month
|
The total score ranges from 0-96, where a high score is the worse outcome
|
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
|
VAS for pain (0-100)
|
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
|
flexion and extension (degrees) which measured by long goniometer
|
post-op 2, 6 week, 3, 6, 12 month
|
complication
Time Frame: until 1 year after surgery
|
such as fracture, infection, stiffness
|
until 1 year after surgery
|
Radiological finding
Time Frame: post-op 2, 6 week, 3, 6, 12 month
|
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
|
post-op 2, 6 week, 3, 6, 12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2020
Primary Completion (ANTICIPATED)
December 1, 2020
Study Completion (ANTICIPATED)
March 1, 2021
Study Registration Dates
First Submitted
July 17, 2020
First Submitted That Met QC Criteria
July 30, 2020
First Posted (ACTUAL)
August 3, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 3, 2020
Last Update Submitted That Met QC Criteria
July 30, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OrthoTU12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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