Back to resultsCemented vs Cementless in Bilateral TKA
Primary Purpose
Osteoarthritis, Total Knee Arthroplasty
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Triathlon
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring cemented, cementless, total knee arthroplasty, short term outcome, functional outcome
Eligibility Criteria
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
Sites / Locations
- Thammasat UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Cemented TKA
Cementless TKA
Arm Description
Cemented TKA (Triathlon, Stryker) include patellar resurfacing
Cementless TKA (Triathlon Tritanium, Stryker) include patellar resurfacing
Outcomes
Primary Outcome Measures
Compare mean Forgotten joint score between 2 groups
The total score ranges from 0-100, where a high score is the best outcome
Secondary Outcome Measures
Operative time
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
Pain level
VAS for pain (0-100)
Range of knee motion
flexion and extension (degrees) which measured by long goniometer
complication
such as fracture, infection, stiffness
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04496102
Brief Title
Cemented vs Cementless in Bilateral TKA
Official Title
Comparison of Efficacy Between Cemented and Cementless Total Knee Arthroplasty in Bilateral Total Knee Arthroplasty. A Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Total Knee Arthroplasty
Keywords
cemented, cementless, total knee arthroplasty, short term outcome, functional outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cemented TKA
Arm Type
Active Comparator
Arm Description
Cemented TKA (Triathlon, Stryker) include patellar resurfacing
Arm Title
Cementless TKA
Arm Type
Experimental
Arm Description
Cementless TKA (Triathlon Tritanium, Stryker) include patellar resurfacing
Intervention Type
Device
Intervention Name(s)
Triathlon
Intervention Description
Modern TKA design (Triathlon) with patellar resurfacing
Primary Outcome Measure Information:
Title
Compare mean Forgotten joint score between 2 groups
Description
The total score ranges from 0-100, where a high score is the best outcome
Time Frame
at 1 year
Secondary Outcome Measure Information:
Title
Operative time
Time Frame
intra-operative assessment
Title
modified the Western Ontario and McMaster Universities Osteoarthritis Index score
Description
The total score ranges from 0-96, where a high score is the worse outcome
Time Frame
post-op 2, 6 week, 3, 6, 12 month
Title
Pain level
Description
VAS for pain (0-100)
Time Frame
Once daily 1-14 days after surgery then once a week until 3 months
Title
Range of knee motion
Description
flexion and extension (degrees) which measured by long goniometer
Time Frame
post-op 2, 6 week, 3, 6, 12 month
Title
complication
Description
such as fracture, infection, stiffness
Time Frame
until 1 year after surgery
Title
Radiological finding
Description
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
Time Frame
post-op 2, 6 week, 3, 6, 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Supakit Kanitnate, M.D.
Phone
+66899853635
Email
naypeng@hotmail.com
Facility Information:
Facility Name
Thammasat University
City
Khlong Luang
State/Province
Pathum Thani
ZIP/Postal Code
12120
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
supakit kanitnate, M.D.
Phone
+66899853635
Email
naypeng@hotmail.com
First Name & Middle Initial & Last Name & Degree
Nattapol Tammachote, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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Cemented vs Cementless in Bilateral TKA
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