NCT04496102

Brief Summary

To compare the functional outcomes between cemented and cementless TKA in bilateral knee replacement patient.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

July 17, 2020

Last Update Submit

July 30, 2020

Conditions

OsteoarthritisTotal Knee Arthroplasty

Keywords

cementedcementlesstotal knee arthroplastyshort term outcomefunctional outcome

Outcome Measures

Primary Outcomes (1)

  • Compare mean Forgotten joint score between 2 groups

    The total score ranges from 0-100, where a high score is the best outcome

    at 1 year

Secondary Outcomes (6)

  • Operative time

    intra-operative assessment

  • modified the Western Ontario and McMaster Universities Osteoarthritis Index score

    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

  • Range of knee motion

    post-op 2, 6 week, 3, 6, 12 month

  • complication

    until 1 year after surgery

  • +1 more secondary outcomes

Study Arms (2)

Cemented TKA

ACTIVE COMPARATOR

Cemented TKA (Triathlon, Stryker) include patellar resurfacing

Device: Triathlon

Cementless TKA

EXPERIMENTAL

Cementless TKA (Triathlon Tritanium, Stryker) include patellar resurfacing

Device: Triathlon

Interventions

TriathlonDEVICE

Modern TKA design (Triathlon) with patellar resurfacing

Cemented TKACementless TKA

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA status 1 or 2
  • Diagnosed with bilateral osteoarthritis of the knees
  • Participant understand and consent to the protocol of the trial

You may not qualify if:

  • Morbid obesity (BMI \>40)
  • Inflammatory arthritis
  • Osteoporosis
  • Metabolic bone disease
  • Bone defect that seen from radiographs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thammasat University

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Supakit Kanitnate, M.D.

CONTACT

+66899853635naypeng@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 17, 2020

First Posted

August 3, 2020

Study Start

March 1, 2020

Primary Completion

December 1, 2020

Study Completion

March 1, 2021

Last Updated

August 3, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)