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Clinical Trials/NCT04496102
NCT04496102UnknownNot Applicable

Comparison of Efficacy Between Cemented and Cementless Total Knee Arthroplasty in Bilateral Total Knee Arthroplasty. A Prospective Randomized Controlled Trial

Thammasat University1 site in 1 country50 target enrollmentStarted: March 1, 2020Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Locations
1
Primary Endpoint
Compare mean Forgotten joint score between 2 groups
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
50 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Cemented TKA

Active Comparator

Cemented TKA (Triathlon, Stryker) include patellar resurfacing

Intervention: Triathlon (Device)

Cementless TKA

Experimental

Cementless TKA (Triathlon Tritanium, Stryker) include patellar resurfacing

Intervention: Triathlon (Device)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Radiological finding(post-op 2, 6 week, 3, 6, 12 month)
  • Pain level(Once daily 1-14 days after surgery then once a week until 3 months)
  • Operative time(intra-operative assessment)
  • modified the Western Ontario and McMaster Universities Osteoarthritis Index score(post-op 2, 6 week, 3, 6, 12 month)
  • complication(until 1 year after surgery)
  • Range of knee motion(post-op 2, 6 week, 3, 6, 12 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Supakit Kanitnate

Principal Investigator

Thammasat University

Study Sites (1)

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