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

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

Study Locations

    • Pathum Thani
      • Khlong Luang, Pathum Thani, Thailand, 12120
        • Recruiting
        • Thammasat University
        • Contact:
        • 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.

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

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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